Open-label, Multicentre Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Ceftaroline In Neonates And Young Infants With Late-onset Sepsis
Phase: PHASE2
Conditions: Late-onset Sepsis
Sponsor: Pfizer

1(88)
Clinical Study Protocol 
Drug Substance
Ceftaroline fosamil
United States (US) Investigational 
New Drug (IND) Number:
71,371
European Clinical Trials Database 
(EudraCT) Number:
2014-003243-34
Pfizer Study Code
C2661002
Astra ZenecaStudy Code
D3720C00009
Version
5.0
Phase
2
Date
25May 2017
Open-label, Multicentre Study to Evaluate the Safety, Tolerability, 
Pharmacokinetics, and Efficacy of Ceftaroline in Neonates and Young 
Infants with Late-Onset Sepsis
Sponsor:Pfizer Inc., 235East 42ndStreet, New York, NY 10017, USA (as of Version5.0) 
Prior Sponsor:AstraZeneca AB, 15185Södertälje, Sweden
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
2(88)
VERSION HISTORY
Version5.0, 25May 2017
The previous version of the protocol (Edition 4, dated 25August 2015) hasbeen revised to reflect 
change in Sponsorship to Pfizer Inc and to include the latest protocol template language of the current 
Sponsor, Pfizer.  The visit window for the Safety Follow Up (SFU) assessment was changed to 28 to 
35 days to be consistent withPfizer’s requirement to follow safety for a minimum of 28 days after the 
last dose of study therapy.  In addition, minor text changes were made to improve protocol clarity.
Version4, 25August2016
The previous version of the protocol (Edition 3, dated 16December 2015) has been 
transferred to the latest AstraZeneca designated template (Protocol Template Version 17.0). 
In addition, the following changes were incorporated into Version 4of the protocol:
Date of pediatricapprovalin the US (May 2016) and EU (June2016) was added.
Inclusion criterion5wasrevised so that patients must meet at least 1of the listedlaboratory
criteria, rather than 2of the criteria.
Followingarequest fromthe Italian Ministry of Health,ajustification was provided forthe dose 
increase to 6mg/kgthat was described in Edition 3of the protocol.
Clarification was added to the effect that theindividual dose of Ceftaroline fosamil should be 
calculated based on the patient’s first weight of the day.
Note: previous versions of the protocol were numbered “Edition 1”, “Edition 2”, etc, but “Edition” has 
now been replaced with “Version”.
Edition 3, 16December 2015
An AstraZeneca Research and Development site representative was added as a signatory to the 
revised protocol.
Clarification was provided for when ampicillin administration is mandatory.
The dose of ceftaroline fosamil to be given was increased to 6mg/kg.
The estimated date for last patient completed and studyend were updated to align with the Pediatric
Investigation Plan for ceftaroline fosamil.
Minor wording changes were added to the text as clarifications.
Note: in addition to the changes listed above, minor formatting/style changes were made.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
3(88)
Edition 2, 23April 2015
1. The definition of preterm neonate wasrevised in order to align with the World Health 
Organization definition of preterm neonates used world-wide. The age requirement for 
Cohort 2(term neonates) wastherefore revisedfrom gestational age ≥38weeks to 
gestational age ≥37weeks.The age requirement for Cohort 3(preterm neonates) was 
revised from gestational age ≥34to <38weeks togestational age ≥34to <37weeks.
2. The discrepancy between units and values for white blood cell and platelet counts in the 
inclusion criteria wascorrected.
3. The definition of Study Day wasclarified –Study Days were to be calculated starting from 
the onset of the first dose of study therapy, in 24-hour increments.
In addition, some minor typographic errors werecorrected.
Edition 1, 18November 2013
Initial creation 
This amendment incorporates all revisions to date, including amendments made at the request 
of country health authorities and institutional boards (IRBs)/ethics committees (ECs).
This submission document contains confidential commercial information, disclosure of which 
is prohibited without providing advance notice to the Sponsorand opportunity to object.
The clinical study protocol is publicly registered and the results are disclosed and/or published 
according to the Sponsor publication policyand in compliance with prevailing laws and 
regulations.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
4(88)
PROTOCOL SYNOPSIS
Open-label, Multicentre Study to Evaluate the Safety, Tolerability, 
Pharmacokinetics, and Efficacy of Ceftaroline in Neonates and Young 
Infants with Late-Onset Sepsis
International Co-ordinating Investigator
The name and contact details of the International Co-ordinating Investigator will be 
communicated by the Sponsor or Sponsor representative to all study centres and any 
applicable regulatory authorities via a certified letter.
Study site(s) and number of patients planned
The study will be conducted in approximately 30centres worldwide.  At least 24patients 
evaluable for safety will be enrolled and treated within the following age cohorts:
Cohort 1: young infants aged >28days to <60days (n=8)
Cohort 2: term neonates (defined as gestational age ≥37weeks) aged 7to ≤28days 
(n=8)
Cohort 3: preterm neonates (defined as gestational age ≥34to <37weeks) aged 
7to≤28days (n=8).
Study period
Estimated date of first patient enrolled
Q12015
Estimated date of last patient completed
December 2017
Study design
This is a multicentre, multinational, open-label, single treatment arm study of intravenous (IV) 
ceftaroline fosamil and ampicillin, plus an optional aminoglycoside of choice, in hospitalized 
neonates and young infants aged 7to <60days with late-onset sepsis (LOS).
Baseline assessments for study eligibility will occur within 36hours before administration of 
the first dose of study therapy.  Study Day 1is defined as the 24-hour period starting at the 
onset of the first administration of study therapy.  Thereafter, subsequent Study Days are to 
follow the same pattern.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
5(88)
Safety assessments will occur throughout the study.  Clinical outcome evaluations will occur 
at End-of-Therapy (EOT; within 24hours after completion of last infusion) and Test-of-Cure 
(TOC; 8to 15days after the last dose of study therapy).
Objectives
Primary Objective:
Outcome Measure:
To evaluate the safety and tolerability of 
ceftaroline for the treatment of LOS in 
neonates and young infants aged 7to <60days
Safety assessments will include adverse events (AEs), 
serious adverse events (SAEs), deaths, and 
discontinuations due to AEs.
Secondary Objective:
Outcome Measure :
To evaluate the pharmacokineticprofile of 
ceftaroline in neonates and young infants aged 
7to <60days with LOS
Concentrations of ceftaroline fosamil, ceftaroline, and 
ceftaroline M-1in plasma (and if available, 
concentrations of ceftaroline and ceftaroline M-1in 
cerebrospinal fluid [CSF])  
To evaluate the efficacy of ceftaroline for the 
treatment of LOS in neonates and young 
infants aged 7to <60days
Efficacy outcome measures will include clinical 
outcome at EOT and TOC in the Modified 
Intent-to-Treat (MITT) Analysis Set.  
Target patientpopulation
Male or female patients, gestational age ≥34weeks, and chronological age 7to <60days with 
a diagnosis of sepsis within 36hours before enrolment, defined as the presence of at least 
2clinical criteria and at least 1laboratory criterionin the presence of or as a result of 
suspected or proven bacterial infection that requires IV antibiotic therapy.
Duration of treatment
Patient participation will require up to 49days.  The total duration of study therapy is 48hours 
(minimum) to 14days (maximum).  Hospitalization is required while on IV study therapy.  
Baseline assessments for study eligibility will occur within 36hours before the first dose of 
study therapy.  The Safety Follow-up(SFU) assessments will occur 28to 35days after the last 
dose of study therapy.
Investigational product, dosage and mode of administration
Ceftaroline fosamil will be given at a dose of 6mg/kg IV over 60(± 10) minutes every 
8hours (q8h) (±1hour).  IV ampicillin and optional aminoglycoside will be given as per 
standard of care.  If the presence of an organism that requires treatment with ampicillin cannot 
be excluded, then the use of IV ampicillin for the first 48hours is mandatory.  If the resultsof 
additional microbiology, polymerase chain reaction (PCR) or other investigations indicate that 
ampicillin during the first 48hours of treatment is not required, then its use is at the discretion 
of the investigator.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
6(88)
Statistical methods
Descriptive statistics (number, mean, standard deviation, median, minimum, and maximum) 
will be provided for continuous variables, and frequency distributions (counts and 
percentages) will be shown for categorical variables.  All variables will be summarized overall 
and by age cohort.  Listings of individual patients’ data will also be produced.
The primary objective of this study is to evaluate the safety and tolerability of ceftaroline in 
neonates and young infants with LOS and the study is not powered for formal statistical 
inference.  The Safety Analysis Set will include all patients who received any amount of 
ceftaroline fosamil.  Safety parameters include AEs, SAEs, deaths, clinical laboratory 
parameters, and vital signs.  For each safety parameter, the last assessment made before the 
first dose of study therapy will be used as the baseline for all analyses.  The incidence of 
adverse events (AEs), serious adverse events (SAEs), deaths, and discontinuations due to AEs 
will be summarized overall and within each age cohort, by system organ class and preferred 
term according to the Medical Dictionary for Regulatory Activities (MedDRA), by 
relationship to the study therapy, and by severity.
Efficacy outcomes will be summarized descriptively using the modified Intent-to-treat 
(MITT) Analysis Set, which will include all patients who receive any amount of ceftaroline 
fosamil and who meet minimal disease criteria of LOS.  An assessment of clinical outcome 
will be made by the investigator at EOT.  Possible outcomes are clinical cure, clinical failure 
or indeterminate.  A favourable clinical outcome is clinical cure.  An outcome of clinical 
failure at EOT will be carried forward to TOC.  A further assessment of clinical outcome will 
be made at TOC.
Per-patientmicrobiological response at TOC will be determined programmatically based on 
individual outcomes for each baseline pathogen.  In order for a patient to have a favourable 
microbiological response, the outcome for each baseline pathogen must be favourable 
(eradicated or presumed eradicated).  If the outcome for any pathogen is unfavourable 
(persistence or presumed persistence), the patient will be considered to have an unfavourable 
microbiological response.
Summaries of demographics and other baseline characteristics will be provided.  The 
incidence of AEs, SAEs, deaths, and discontinuations due to AEs will be summarized by 
system organ class and preferred term according to the Medical Dictionary for Regulatory 
Activities, by relationship to study therapy, and by severity.  Descriptive statistics of observed 
results and the change from baseline to selected postbaseline time points will be presented for 
clinical laboratory results and vital signs.  The incidence of selected potentially clinically 
significant laboratory results will be summarized.
The pharmacokinetic (PK) Analysis Set will include all patients who receive a known amount 
of ceftaroline fosamil and who have had at least 1PK sample collected.  The PK data 
acquisition and analysis strategy in this study entails the use of a sparse PK sampling 
schedule, conducted only at selected investigational centres.  Plasma concentrations of 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
7(88)
ceftaroline fosamil, ceftaroline and ceftaroline M-1, and cerebrospinal fluid (CSF) 
concentrations of ceftaroline and ceftaroline M-1will be listed by age cohort.  Ceftaroline 
plasma concentration data, along with other information including demographic data, will be 
combined with appropriate data from other clinical studies and analysed using a population 
PK approach and reported separately.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
8(88)
TABLE OF CONTENTS
PAGE
LIST OF TABLES..................................................................................................................14
LIST OF FIGURES.................................................................................................................14
1. INTRODUCTION...............................................................................................................18
1.1. Background and rationale for conducting this study..............................................18
1.2. Rationale for study design, doses and control groups.............................................19
1.3. Benefit/risk and ethical assessment........................................................................20
1.4. Study Design...........................................................................................................22
2. STUDY OBJECTIVES.......................................................................................................24
2.1. Primary objective....................................................................................................24
2.2. Secondary objectives..............................................................................................24
2.3. Safety objectives.....................................................................................................24
2.4. Exploratory objectives (not applicable)..................................................................24
3. PATIENT SELECTION, ENROLMENT, RANDOMISATION, RESTRICTIONS, 
DISCONTINUATION AND WITHDRAWAL.................................................................24
3.1. Inclusion criteria.....................................................................................................24
3.2. Exclusion criteria....................................................................................................25
3.3. Patient enrolment....................................................................................................26
3.4. Procedures for handling incorrectly enrolled patients............................................27
3.5. Methods for assigning treatment groups.................................................................27
3.5.1. Stratification by age and cohort..................................................................27
3.5.2. Assignment to PK schedule........................................................................27
3.6. Methods for ensuring blinding................................................................................28
3.7. Methods for unblinding...........................................................................................28
3.8. Restrictions.............................................................................................................28
3.9. Discontinuation of investigational product.............................................................28
3.9.1. Procedures for discontinuation of a patient from investigational 
product.............................................................................................................28
3.9.1.1. Discontinuations Due to Safety................................................28
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
9(88)
3.9.1.2. Discontinuations Due to Insufficient Therapeutic Effect.........29
3.10. Criteria for withdrawal..........................................................................................30
3.10.1. Screen failures..........................................................................................30
3.10.2. Withdrawal of the informed consent........................................................31
3.11. Discontinuation of the study.................................................................................31
3.12. Sponsor’s Qualified Medical Personnel................................................................31
4. STUDY PLAN AND TIMING OF PROCEDURES..........................................................32
4.1. Baseline...................................................................................................................35
4.1.1. Baseline assessments..................................................................................35
4.1.1.1. Clinical assessments..................................................................35
4.1.1.2. Laboratory assessments............................................................36
4.1.1.3. Microbiological assessments....................................................36
4.2. Treatment period.....................................................................................................37
4.2.1. StudyDay 1(starts with onset of study drug administration)....................37
4.2.1.1. Study therapy administration....................................................37
4.2.1.2. Clinical assessments -after at least 1dose of study therapy....37
4.2.1.3. Laboratory assessments -after at least 1dose of study 
therapy...............................................................................................38
4.2.1.4. Microbiological assessments -after at least 1dose of study 
therapy...............................................................................................38
4.2.2. Study Day 2(starts 24hours after onset of study drug administration).....38
4.2.2.1. Study therapy administration....................................................38
4.2.2.2. Clinical assessments -any time during study day....................39
4.2.2.3. Laboratory assessments -any time during study day...............39
4.2.2.4. PK procedures...........................................................................39
4.2.2.5. Microbiological assessments -any time during study day.......40
4.2.3. Study Day 3(starts 48hours after onset of study drug administration).....40
4.2.3.1. Study therapy administration....................................................40
4.2.3.2. Clinical assessments -any time during study day....................41
4.2.3.3. Laboratory assessments -any timeduring study day...............41
4.2.3.4. Microbiological assessments -any time during study day.......41
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
10(88)
4.2.3.5. PK procedures...........................................................................42
4.2.4. Study Days 4through 14(starts 72hours after onset of study drug 
administration and an extra 24hours for each day thereafter)........................42
4.2.4.1. Study therapy administration....................................................42
4.2.4.2. Clinical assessments -any time during study day....................42
4.2.4.3. Laboratory assessments -any time during study day...............43
4.2.4.4. Microbiological assessments -any time during study day.......43
4.2.4.5. PK procedures...........................................................................43
4.2.5. End-of-Therapy (EOT)...............................................................................43
4.2.5.1. Clinical assessments -after the last dose of study therapy.......44
4.2.5.2. Laboratory assessments -after the last dose of study 
therapy...............................................................................................44
4.2.5.3. Microbiological assessments -after the last dose of study 
therapy...............................................................................................45
4.3. Follow-up period.....................................................................................................45
4.3.1. Test-of-Cure (TOC)....................................................................................45
4.3.1.1. Clinical assessments..................................................................45
4.3.1.2. Laboratory assessments............................................................46
4.3.1.3. Microbiological assessments....................................................46
4.3.2. Safety Follow-Up (SFU)............................................................................46
4.3.2.1. If SFU conducted via telephone................................................46
4.3.2.2. If SFU conducted in person......................................................47
5. STUDY ASSESSMENTS...................................................................................................47
5.1. Efficacy assessments...............................................................................................47
5.2. Microbiological assessments..................................................................................48
5.2.1. Blood sample for culture............................................................................48
5.2.2. Urine sample for culture.............................................................................48
5.2.3. Cerebrospinal fluid for culture...................................................................48
5.2.4. Other specimens and tissue samples for culture.........................................49
5.3. Safety assessments..................................................................................................49
5.3.1. Laboratory safety assessments...................................................................49
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
11(88)
5.3.2. Other clinical assessments..........................................................................50
5.3.3. Adverse events...........................................................................................51
5.4. Pharmacokinetics....................................................................................................51
5.4.1. Collection of blood samples.......................................................................51
5.4.2. Collection of cerebrospinal fluid samples..................................................52
5.4.3. Determination of drug concentration.........................................................52
5.4.4. Storage and destruction of pharmacokinetic samples................................52
5.5. Pharmacodynamics (not applicable).......................................................................53
5.6. Pharmacogenetics (not applicable).........................................................................53
5.7. Biomarker analysis (not applicable).......................................................................53
5.8. Volume of blood.....................................................................................................53
6. ADVERSE EVENT REPORTING AND MEDICAL MANAGEMENT..........................53
6.1. Requirements..........................................................................................................53
6.1.1. Additional Details On Recording Adverse Events on the CRF.................55
6.1.2. Eliciting Adverse Event Information.........................................................55
6.1.3. Withdrawal From the Study Due to Adverse Events.................................55
6.1.4. Time Period for Collecting AE/SAE Information......................................55
6.1.4.1. Reporting SAEs to Pfizer Safety...............................................55
6.1.4.2. Recording Non-serious AEs and SAEs on the CRF.................56
6.1.5. Causality Assessment.................................................................................56
6.1.6. Sponsor’s Reporting Requirements to Regulatory Authorities..................56
6.2. Definitions...............................................................................................................56
6.2.1. Adverse Events...........................................................................................56
6.2.2. Abnormal Test Findings.............................................................................57
6.2.3. Serious Adverse Events..............................................................................58
6.2.4. Hospitalization............................................................................................58
6.3. Severity Assessment...............................................................................................60
6.4. Special Situations....................................................................................................60
6.4.1. Potential Cases of Drug-Induced Liver Injury...........................................60
6.4.2. Exposure to the Investigational Product During Pregnancy or
Breastfeeding, and Occupational Exposure.....................................................62
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
12(88)
6.4.2.1. Exposure During Pregnancy.....................................................62
6.4.2.2. Exposure During Breastfeeding................................................62
6.4.2.3. Occupational Exposure.............................................................62
6.4.3. Medication Errors and Lack of Efficacy....................................................62
6.4.3.1. Medication Errors.....................................................................63
6.4.3.2. Lack of Efficacy........................................................................63
6.5. Study governance and oversight.............................................................................63
6.5.1. Data and Safety Monitoring Board............................................................63
7. INVESTIGATIONAL PRODUCT AND OTHER TREATMENTS..................................64
7.1. Identity of investigational product(s)......................................................................64
7.1.1. Ceftaroline Fosamil....................................................................................64
7.1.1.1. Directions for Use.....................................................................64
7.1.1.2. Drug Storage.............................................................................64
7.1.2. Ampicillin and Optional Aminoglycoside.................................................65
7.2. Dose and treatment regimens..................................................................................65
7.2.1. Ceftaroline fosamil.....................................................................................65
7.2.2. Ampicillin...................................................................................................65
7.2.3. Aminoglycoside..........................................................................................65
7.2.4. Dose adjustment.........................................................................................66
7.3. Labelling.................................................................................................................66
7.4. Storage....................................................................................................................66
7.5. Compliance.............................................................................................................67
7.6. Accountability.........................................................................................................67
7.6.1. Study drug handling and disposal..............................................................67
7.7. Concomitant and other treatments..........................................................................67
7.7.1. Other concomitant treatment......................................................................68
8. STATISTICAL ANALYSES..............................................................................................68
8.1. Statistical considerations.........................................................................................68
8.2. Sample size estimate...............................................................................................68
8.3. Definitions of analysis sets.....................................................................................68
8.3.1. Intent-to-treat analysis set..........................................................................68
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
PFIZER CONFIDENTIAL
13(88)
8.3.2. Safety analysis set......................................................................................68
8.3.3. Modified intent-to-treat (MITT) analysis set.............................................68
8.3.4. Pharmacokinetic (PK) analysis set.............................................................68
8.4. Outcome measures for analyses..............................................................................69
8.4.1. Efficacy response definitions.....................................................................69
8.4.1.1. Clinical outcome at End-of-Therapy........................................69
8.4.1.2. Clinical outcome at Test-of-Cure..............................................70
8.4.2. Microbiological response definitions.........................................................71
8.4.2.1. Microbiological Outcome at Test-of-Cure................................71
8.5. Methods for statistical analyses..............................................................................72
8.5.1. Analysis of the study population and patient characteristics.....................72
8.5.2. Analysis of the primary variable................................................................72
8.5.3. Analysis of the secondary variables...........................................................73
8.5.3.1. Pharmacokinetic sample collection and analyses.....................73
8.6. Interim Analysis......................................................................................................73
9. STUDY AND DATA MANAGEMENT............................................................................74
9.1. Training of study site personnel..............................................................................74
9.2. Monitoring of the study..........................................................................................74
9.2.1. Source data.................................................................................................75
9.2.2. Study agreements.......................................................................................75
9.2.3. Archiving of study documents...................................................................75
9.2.3.1. Data handling and record keeping............................................76
9.3. Study timetable and end of study............................................................................77
9.3.1. Study completion........................................................................................77
9.3.2. Guidance to investigators on when to end study therapy...........................77
9.3.3. Study termination by Sponsor and termination criteria..............................78
9.4. Data management....................................................................................................78
10. ETHICAL AND REGULATORY REQUIREMENTS....................................................79
10.1. Ethical conduct of the study..................................................................................79
10.2. Patient data protection...........................................................................................80
10.3. Ethics and regulatory review................................................................................80
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
14(88)
10.4. Informed consent..................................................................................................81
10.5. Changes to the protocol and informed consent form............................................82
10.6. Audits and inspections..........................................................................................82
10.7. Reporting of safety issues and serious breaches of the protocol or ICH GCP.....83
10.8. Publication of study results...................................................................................83
10.9. Communication of results by the Sponsor............................................................83
10.9.1. Publications by investigators....................................................................84
11. LIST OF REFERENCES...................................................................................................86
APPENDIX A
INTERNATIONAL AIRLINE TRANSPORTATION 
ASSOCIATION (IATA) 6.2GUIDANCE DOCUMENT.................................................88
LIST OF TABLES
Table 1
Study Plan detailing the procedures.....................................................................33
Table 2
Laboratory Safety Variables.................................................................................50
Table 3
Volume of blood per patient.................................................................................53
Table 4
Clinical outcome categories at End-of-Therapy...................................................70
Table 5
Clinical outcome categories at Test-of-Cure........................................................71
Table 6
Per-pathogen microbiological outcomes categories at End of Treatment and 
Test-of-Cure.........................................................................................................72
LIST OF FIGURES
Figure 1
Study Diagram......................................................................................................23
Figure 2
Study Analysis Sets..............................................................................................69
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
15(88)
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS
The following abbreviations and special terms are used in this study Clinical Study Protocol.
Abbreviation or 
special term
Explanation
ABSSSI
Acute bacterial skin and skin structure infections
AE
Adverse event
ALT
Alanine aminotransferase
AST
Aspartate aminotransferase
AUC0-24h
Area under the curvefrom 0to 24hours
BE
Base excess
CA
Competent Authority
CABP
Community acquired bacterial pneumonia
CAP
Community-acquired pneumonia
CBC
Complete blood count
CRF
Case report form
Cmax
Maximum concentration
CNS
Central nervous system
CRF
Case Report Form (electronic/paper)
CRP
C-reactive protein
CRS
Catheter-related sepsis
CSA
Clinical Study Agreement
CSF
Cerebrospinal fluid
CSR
Clinical Study Report
CT
Computed tomography 
CXR
Chest radiograph  
DILI
Drug-induced liver injury
DSMB
Data and Safety Monitoring Board  
EDC
Electronic data capture 
EOT
End-of-Therapy 
EudraCT
European Clinical Trials Database
FDA
Food and Drug Administration 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
16(88)
Abbreviation or 
special term
Explanation
GCP
Good Clinical Practice
GMP
Good Manufacturing Practice 
HIV
Human immunodeficiency virus
IB
Investigator’s Brochure
ICH
International Conference on Harmonisation
IEC
Independent Ethics Committee
IND
Investigational New Drug
International 
Co-ordinating 
investigator
If a studyis conducted in several countries the International Co-ordinating 
Investigator is the Investigator co-ordinating the investigators and/or 
activities internationally  
IP
Investigational product 
IRB
Institutional Review Board
ITT
Intent-to-treat  
IV
Intravenous
IXRS
Interactive voice/web response system
LOS
Late-onset sepsis
MedDRA
Medical Dictionary for Regulatory Activities 
MIC
Minimum inhibitory concentration
MITT
Modified intent-to-treat (MITT) 
MRI
Magnetic resonance imaging
MRSA
Methicillin-resistant Staphylococcus aureus
NEC
Necrotizing enterocolitis
PCR
Polymerase chain reaction
PCS
Potentially clinically significant
PI
Principal Investigator 
PK
Pharmacokinetic
PTA
Probability of target attainment
q8h
Every 8hours
q12h
Every 12hours
SAE
Serious adverse event 
SAP
Statistical analysis plan 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
17(88)
Abbreviation or 
special term
Explanation
SFU
Safety follow-up
SPC
Summary of product characteristics
Tbili
Total bilirubin
TOC
Test-of-Cure 
ULN
Upper limit of normal
US
United States
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
18(88)
1.INTRODUCTION
1.1.Background and rationalefor conducting this study
Ceftaroline is a β-lactam antibiotic of the cephalosporin class with broad-spectrum activity 
against gram-positive bacteria including methicillin resistant Staphylococcus aureus (MRSA) 
and penicillin-resistant S. pneumonia (PRSP), as well as against common gram-negative 
bacteria.  Ceftaroline inhibits bacterial cell wall biosynthesis by binding to 1or more 
penicillin-binding proteins, which inhibits their function and causes the bacteria to die.  
Ceftaroline exhibits unique properties that distinguish it from other β-lactams due to its high 
affinity for PBP2a in MRSA, and PBP2x in PRSP that contribute to its potent antibacterial 
activity against these organisms.
Teflaro®(ceftaroline fosamil, the prodrug of ceftaroline) is indicated in adult and pediatric
patients 2months of age and older for the treatment of acute bacterial skin and skin structure 
infections (ABSSSI) and for the treatment of community-acquired bacterial pneumonia 
(CABP).  Teflaro was approved in the US for ABSSSI and CABP in adults in October 2010.  
Pediatricapproval in the US was May 2016.  In August 2012, it was approved as Zinforo™ 
for use in adults for the treatment of complicated skin and soft tissue infection and 
community-acquired pneumonia (CAP) in the European Union and Chile.  Pediatricapproval 
in the European Union was June 2016.  Since 2012, Zinforo™ has been approved in over 
50countries, including Russia, Australia, Malaysia, and Singapore, and approval is being 
sought in additional countries.  Refer to the current ceftaroline fosamil Investigator’s Brochure 
(IB) and ceftaroline fosamil product information18,19for summaries of the nonclinical, 
microbiology, pharmacology, and clinical studies.
A pediatricdevelopment program to evaluate the use of ceftaroline fosamil in children under 
18years old is currently underway.  Two Phase I studies designed to assess the safety, 
tolerability, and pharmacokinetics (PK) of ceftaroline fosamil in children have been 
completed (Study P903-15in adolescent patients aged 12to 17years and Study P903-21in 
children aged from birth to <12years).  The program includes three completed studies in 
patients from 2months to <18years of age: 2Phase 2/3studies (Study P903-23in ABSSSI 
and Study P903-31in CABP requiring hospitalization) and a Phase 4study (Study P903-24in 
complicated CABP). 
Late-onset sepsis (LOS), or sepsis neonatorum, is a severe infectious disease, one of the main 
causes of mortality andmorbidity among neonates and young infants around the world, and 
has different epidemiology, microbiology, and pathophysiology than other age populations.
1,8
The purpose of this study is to assess the safety, tolerability, PK, and efficacy of ceftaroline 
fosamil and ampicillin, plus an optional aminoglycoside of choice, in neonates and young 
infants with LOS.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
19(88)
1.2.Rationale for study design, doses and control groups
This open-label, multicentre, multinational, single treatment arm study will evaluate the 
safety, tolerability, PK, and efficacy of ceftaroline in the target population, neonates and 
young infants with LOS.  Pediatricpatients (7to <60days) with suspected or confirmed LOS 
will be enrolled in this study.
The aetiology of LOS is nosocomial or community acquired.  Ceftaroline has activity against 
common gram-positive pathogens, including MRSA, and gram-negative pathogens including 
Enterobacteriaceae (with the exception of those producing extended-spectrum β-lactamase), 
which makes it appropriate for use in community-acquired and nosocomial infections.
5,14,18
Immediate administration of antibiotic therapy with broad-spectrum activity is critical in 
patients with LOS.  The purpose of therapy is to prevent morbidity and decrease mortality 
which is likely to happen without therapy or with inadequate therapy.  Starting the appropriate 
antibacterial drug without delay, while awaiting culture results, decreases mortality rate 
dramatically.4,10  As therapy must be prescribed as soon as possible, the choice of drugs 
should be made empirically based on epidemiology and possible aetiology agent.  The priority 
should be given to bactericidal drugs with broad-spectrum coverage of gram-positive and 
gram negative microorganisms. 
Ceftaroline, with its broad-spectrum activity has the potential to provide a valuable therapeutic 
option in the treatment of LOS.  Ceftaroline was well tolerated in adult and pediatricclinical 
trials and has a safety profile consistent with available marketed cephalosporins, a class of 
antibiotics with a long history of clinical use.
The combination of ampicillin and an optional aminoglycoside of choice was chosen as the 
recommended empirical therapy because of its ability to achieve maximum coverage of 
gram-positive andgram-negative pathogens of LOS and as an effective standard of care 
antibiotic therapy for this indication, which is accepted in clinical practice 
worldwide.2,9,11,15,16,17
The dosing regimen for ceftaroline (6mg/kg q8h as a 1-hour infusion)was chosen based on a 
population PK model updated with PK data from three multiple dose safety and efficacy 
studies in children from 2months to <18years (Studies P903-23, P903-31and P903-24).13  
These data have been used in conjunction with adult patient and healthy volunteer data and 
data from single dose ceftaroline PK studies conducted in children from neonates to 
<18years. The ceftaroline population PK model incorporates allometric scaling for body 
weight and maturation of renal function.  This model was used in Monte Carlo simulations to 
choose and justify the dose regimens for children from 2months to 18years, now included on 
the European Summary of Product Characteristics (SmPC)and US Food and Drug
Administration(FDA)label.  The same model hasbeen used to predict doses for children 
<2months, including pre-term neonates (with a post-menstrual age of 28to 41weeks). 
Post-menstrual age is defined as gestational age plus chronological age.  Various dosing 
regimens simulated using body weights for each simulated patient were predicted based on 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
20(88)
age in accordance with either CDC growth charts
7for neonates that were born to term orin 
accordance with intrauterine growth curves
12for preterm and to-term neonates (gestational 
age 32-40weeks).  One hundredsimulations were performed for each dose with 
600(300male and 300female) patients from each age group.  The age groups were 
categorised as follows: 28to <30, 30to <32, 32to <34, 34to <36, 36to<38, 38to 
<40post-menstrual weeks, 0to <1, 1to <2, 2to <6, 6to <12, 12to <18, 18to<24months.
Using this model, several dose regimens have been assessed and a dose of 6mg/kg ceftaroline 
fosamil q8h as a 1-hour infusion is predicted to achieve >90% probability of target attainment
(PTA)for minimum inhibitory concentrations (MICs)≤2mg/L.  Predicted ceftaroline 
exposures (based on steady-state maximum concentration [Cmax]and area under the curve 
from 0to24hours[AUC0-24h]) in pediatricpatients younger than 2months old and of 
gestational age 32-48weeks dosed with 6mg/kg q8h as a 1-hour infusion do not appreciably 
exceed ceftaroline exposures in adults dosed with the currently approved ceftaroline fosamil 
regimen of 600mg every 12hours (q12h). The median steady-state ceftaroline C
maxvalues in 
pediatricpatients in this age range dosed with the proposed regimen are predicted to be less 
than the median C
maxvalue in adults dosed with 600mg q12h.  Median steady-state 
ceftaroline AUC
0-24hvalues in pediatricpatients younger than 2months old and of gestational 
age 32-48weeks dosed with the proposed regimen are predicted to be no more than 
17%higher than the median adult value. 
Based on these findings, the updated model has been used to optimise the dose(6mg/kg q8h 
as a 1-hour infusion). 
1.3.Benefit/risk and ethical assessment
Patients enrolled into this clinical study will have LOS of sufficient severity to require 
hospitalization and treatment with IV antibiotics.  The potential benefit to patients 
participating in this study is that they will receive effective antibiotic therapy for their 
infection.  The potential benefit of this study, in general, is theidentification of a new addition 
to the available antibiotic therapy that is a safe and effective treatment for LOS, in the face of 
the changing pattern of antibiotic resistance. 
It is possible that ceftaroline fosamil and ampicillin will not prove to bea sufficiently effective 
treatment for LOS.  This risk is mitigated by the possible option of adding an aminoglycoside, 
by close monitoring of study patients, and by management with appropriate therapies as 
determined by the investigator providing treatment.
The risk considerations for this study encompass the known and potential risks for ceftaroline 
fosamil, as well as those risks associated with other treatments that may be administered as 
described in this protocol (ampicillin and optional aminoglycoside).  As the risks for these 
marketed products are widely available in their respective prescribing information, these risks 
will not be discussed within this section.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
21(88)
The risks for use of ceftaroline fosamil in children <2months of age have not been fully 
elucidated; however it is assumed that known or potential risks for ceftaroline fosamil should 
include those identified from adult use and in clinical studies in adults and in children and 
adolescents.  Additional risk information for ceftaroline fosamilis located in the Investigator’s 
Brochure.
The full risk profile for ceftaroline fosamil is described in the prescribing information for the 
product.  Important risks as laid out in the warnings and precautions in product labelling for 
ceftaroline fosamilinclude:
Hypersensitivity reactions:  though patients with hypersensitivity reactions to β lactam 
antibiotics are excluded from the trial, first-time episodes of such reactions could 
occur.
Antibiotic-associated diarrhoea: Clostridium difficile-associated diarrhoeahas been 
reported for nearly all systemic antibacterial agents, including ceftaroline fosamil, and 
may range in severity from mild diarrhoea to fatal colitis.
Direct Coombs
' Test Seroconversion: seroconversion from a negative to a positive test 
result occurred in more patients receiving ceftaroline fosamil than comparator drugs in 
pooled data from 4Phase III clinical trials.  If anaemia develops during or after 
treatment with ceftaroline fosamil, drug-induced haemolytic anaemia should be 
considered.
Development of Drug-Resistant Bacteria: prescribing ceftaroline fosamil in the 
absence of a proven or strongly suspected bacterial infection is unlikely to provide 
benefit to the patient and increases the risk of the development of drug-resistant 
bacteria.
Adverse Reactions: in the four pooled Phase III clinical trials, SAEs occurred in 
98/1300(7.5%) of patients receiving ceftaroline fosamil and 100/1297(7.7%) of 
patients receiving comparator drugs.  Treatment discontinuation due to adverse events 
occurred in 35/1300(2.7%) of patients receiving ceftaroline fosamil and 
48/1297(3.7%) of patients receiving comparator drugs with the most common adverse 
events leading to discontinuation being hypersensitivity for both treatment groups at a 
rate of 0.3% in the ceftaroline fosamil group and 0.5% in the comparator group.
No adverse reactions occurred in greater than 5% of patients receiving ceftaroline 
fosamil.  The most common adverse reactions occurring in >2% of patients receiving 
ceftaroline fosamil in the pooled Phase 3clinical trials were diarrhea, nausea, and rash.
No clinical drug-drug interaction studies have been conducted with ceftaroline fosamil.  There 
is minimal potential for drug-drug interactions between ceftaroline fosamil and 
CYP450substrates, inhibitors, or inducers; drugs known to undergo active renal secretion; 
and drugs that may alter renal blood flow.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
22(88)
Safety and effectiveness in pediatricpatients <2months of age have not been established.
Dosage adjustment is required in patients with moderateor severe renal impairment and in 
patients with end-stage renal disease (CrCl <15mL/min).
The PK of ceftaroline in patients with hepatic impairment has not been established.
1.4.Study Design 
This will be an open-label, single arm study with no randomization.  The study will be 
conducted in approximately 30centres worldwide.  At least 24patients with LOS will be 
enrolled and treated within three age cohorts of 8patients: young infants aged >28days to 
<60days; term neonates aged 7to ≤28days; and preterm neonates aged 7to ≤28days. 
Study therapy consists of standard of care ampicillin plus an optional aminoglycoside of 
choice, with the addition of intravenous (IV) ceftaroline fosamil, and will be given to all 
patients.  If the presence of an organism that requires treatment with ampicillin cannot be 
excluded, then the use of IV ampicillin for the first 48hours is mandatory.  If the resultsof 
additional microbiology, polymerase chain reaction (PCR) or other investigations indicate that 
ampicillin during the first 48hours of treatment is not required, then its use is at the discretion 
of the investigator. 
Ceftaroline fosamil will be given at a dose of 6mg/kg IV over 60(± 10) minutes q8h 
(±1hour). 
Patient participation will require up to 49days.  The total duration of study therapy is 48hours 
(minimum) to 14days (maximum).  Hospitalization is required during IV study therapy.  
Baseline assessments for study eligibility will occur within 36hours before the first dose of 
study therapy.  The Safety Follow-up(SFU) assessments will occur 28to 35days after the last 
dose of study therapy.
Safety assessments will be done throughout the study.  Between Day 2and Day 14, 2blood 
samples will be collected for PK analysis.  The efficacy of ceftaroline will be evaluated based 
on the clinical outcome (clinical cure, clinical failure or intermediate) at end of therapy (EOT) 
and test-of-cure (TOC) assessment. 
An external Data and Safety Monitoring Board (DSMB) will review data on a regular basis to 
assess the safety of all patients enrolled in this and other ongoing pediatricstudies 
(Section6.5.1).
The study design is described in the Study Diagram (Figure 1).
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
23(88)
Figure 1 Study Diagram
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
24(88)
2.STUDY OBJECTIVES
2.1.Primary objective
Primary Objective:
Outcome Measure:
To evaluate the safety and tolerability of 
ceftaroline for the treatment of LOS in 
neonatesand young infants aged 7to <60days
Safety evaluations will be conducted in the Safety 
Analysis Set and assessments will include AEs, 
SAEs, deaths, and discontinuations due to AEs.
2.2.Secondary objectives
Secondary Objective:
Outcome Measure :
To evaluatethe PK profile of ceftaroline in 
neonates and young infants aged 7to <60days 
with LOS
Concentrations of ceftarolinefosamil, ceftaroline,and 
ceftaroline M-1in plasma (and if available, 
concentrations of ceftaroline and ceftaroline M-1in 
cerebrospinalfluid [CSF])  
Evaluate the efficacy of ceftaroline for the 
treatment of LOS in neonates and young 
infants aged 7to <60days
Efficacy outcome measures will include clinical 
outcome at EOT and TOC in the Modified 
Intent-to-Treat (MITT) Analysis Set.  
2.3.Safety objectives
Safety is the primary objective.
2.4.Exploratory objectives(not applicable)  
3.PATIENT SELECTION, ENROLMENT, RANDOMISATION, RESTRICTIONS, 
DISCONTINUATION AND WITHDRAWAL 
This study can fulfill its objectives only if appropriate subjects are enrolled.  The following 
eligibility criteria are designed to select subjects for whom participation in the study is 
considered appropriate.  All relevant medical and nonmedical conditions should be taken into 
consideration when deciding whether a particularsubject is suitable for this protocol.
Subject eligibility should be reviewed and documented by the investigator or appropriate 
member his/hersite study team before subjects are included in the study.  Each patientshould 
meet all of the inclusion criteria and none of the exclusion criteria for this study.  Under no 
circumstances can there be exceptions to this rule.
3.1.Inclusion criteria
For inclusion in the study patients should fulfil the following criteria:
1. Informed consent in writing from parent(s) or other legally-acceptable representative(s)
2. Male or female, gestational age ≥34weeks, and chronological age 7to <60days at the 
time of screening
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
25(88)
3. Diagnosis of sepsis within 36hours before enrolment, defined as the presence of at least 
2clinical criteriaand at least 1laboratory criterionin the presence of or as a result of 
suspected or proven bacterial infection that requires IV antibiotic therapy.
4. Patients must meet at least 2of the following clinical criteria:
a. Hypothermia (<36°C) OR fever (>38.5°C)
b. Bradycardia OR tachycardia OR rhythm instability
c. Urine output 0.5to 1mL/kg/h OR hypotension OR mottled skin OR impaired 
peripheral perfusion
d. Petechial rash OR sclerema neonatorum
e. New onset or worsening of apnoea episodes OR tachypnoea episodes OR increased 
oxygen requirements OR requirement for ventilation support
f. Feeding intolerance OR poor sucking OR abdominal distension
g. Irritability
h. Lethargy
i. Hypotonia.
5. Patients must meet at least 1of the following laboratory criteria:
a. White blood cell count ≤4.0× 109/L OR ≥20.0× 109/L
b.Immature to total neutrophil ratio >0.2
c. Platelet count ≤100× 109/L
d. C-reactive protein (CRP) >15mg/L OR procalcitonin ≥2ng/mL
e. Hyperglycaemia OR Hypoglycaemia
f. Metabolic acidosis.
3.2.Exclusion criteria
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
1. Documented history of any hypersensitivity or allergic reaction to any β-lactam antibiotic 
or aminoglycoside
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
26(88)
2. At study entry, has confirmed infection with a pathogen known to be resistant to the 
combination of ceftaroline fosamil, ampicillin, and the optional aminoglycoside of choice 
OR confirmed viral, fungal, or parasitic pathogen as the sole cause of infection
3. Refractory septic shock within 24hours before enrolment that does not resolve after 
60minutes of vasopressor therapy
4. Moderate or severe renal impairment defined as serum creatinine ≥2times the upper limit 
of normal (× ULN) for age OR urine output <0.5mL/kg/h (measured over at least 8hours) 
OR requirement for dialysis
5. Evidence of progressively fatal underlying disease, or life expectancy of ≤60days
6. Documented history of seizure
7. Requiring or currently taking antiretroviral therapy for human immunodeficiency virus 
(HIV) or a child from an HIV positive mother
8. Proven or suspected central nervous system (CNS) infection (eg, meningitis, brain 
abscess, subdural abscess), osteomyelitis, endocarditis, or necrotizing enterocolitis (NEC)
9. Any condition (eg, cystic fibrosis, urea cycle disorders), antepartum/peripartum factors, or 
procedures that would, in the opinion of the investigator, make the patient unsuitable for 
the study, place a patient at risk, or compromise the quality of data
10.Patient
's parent(s) or legally-acceptable representative(s) involvement in the planning 
and/or conduct of the study (applies to both Sponsorstaff and/or staff at the study site).  
Concurrent participation in another clinical study with an investigational product (IP), 
previous enrolment/participation in this study, or participation in another study of 
ceftaroline fosamil within 14days before the intended start of the first dose of study 
therapy.
For procedures for withdrawal of incorrectly enrolled patients see Section 3.4.
3.3.Patientenrolment 
This is a non-randomized open-label study.  Patients will be enrolled ifthey meet all the 
inclusion criteria, including informed consent in writing from parent(s) or other 
legally-acceptable representative(s), and none of the exclusion criteria.  Patients will be 
stratified by age cohort as described in Section 3.5.1.  Patients will be randomly assigned in 
the PK portion of the study to PK Schedule 1or 2(Section 3.5.2). 
The investigator(s) will be responsible for patient management.  Assessments and procedures 
should be conducted as noted in Section 4.  The Pharmacist or designee will prepare study 
therapy infusions and manage dose adjustments, as applicable.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
27(88)
Patients who are withdrawn from study before receiving any amount of study therapy will be 
replaced in order to enrol a total of 24treated patients for safety evaluations.
3.4.Procedures for handling incorrectly enrolled patients
Patients who fail to meet the eligibility criteria should not, under any circumstances, receive 
study medication.  There can be no exceptions to this rule.  Patients who are enrolled, but 
subsequently found not to meet all the eligibility criteria must not be initiated on treatment.
Where a patient does not meet all the eligibility criteria but is incorrectly started on treatment, 
the investigator should inform the Sponsorstudy physician/designee immediately, and a 
discussion should occur between theSponsorstudy physician/designee and the investigator 
regarding whether to continue or discontinue the patient from treatment.  The Sponsorstudy 
physician/designee must ensure all decisions are appropriately documented.
3.5. Methods for assigning treatment groups
3.5.1.Stratification by age and cohort
This study is not randomized, but patients will be stratified by age cohort and randomly 
assigned for assessment of PK to PK Schedule 1or 2(Section 3.5.2).
At least 24patients evaluable for safety will be enrolled and treated within the following age 
cohorts:
Cohort 1: young infants aged >28days to <60days (n=8)
Cohort 2: term neonates (defined as gestational age ≥37weeks) aged 7to ≤28days 
(n=8)
Cohort 3: preterm neonates (defined as gestational age ≥34to <37weeks) aged 
7to≤28days (n=8).
3.5.2.Assignment to PK schedule
Two PK samples (approximately 0.3to 0.6mL perdraw) will be obtained at steady state from 
at least 20patients.  Patients will be randomly assigned (1:1) at the time of enrolment to one 
of the PK sample collection schedules: 
PK Schedule 1: at the end of the ceftaroline fosamil infusion (± 5minutes)and 3to 
4hours after the end of the infusion
PK Schedule 2: 15minutes to 2hours after the end of the ceftaroline fosamil infusion 
and 5to 7hours after the end of the infusion (before the start of the next infusion)
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
28(88)
3.6.Methods for ensuring blinding
Thisstudy is not blinded.  The investigators, pharmacists or designees, study centre personnel, 
and parent(s)/legally-acceptable representative(s) will be aware of study therapy being 
administered.
3.7. Methods for unblinding 
The study is not blinded.
3.8.Restrictions
Concomitant use of potentially effective systemic antibacterial therapy (other than study 
therapy), or any drug known to exhibit a contraindicated drug-drug interaction with any study 
therapy or labelled contraindication to use of any study therapy is not allowed.
3.9.Discontinuation of investigational product
At any time, parent(s) or legally-acceptable representative(s) are free to discontinue the patient 
from treatment with IPor withdraw the patient from the study (ie, IPand assessments –see 
Section 3.10.2), without prejudice to further treatment.  Parent(s) or legally-acceptable 
representative(s) who decide to discontinue a patient from treatment with IPwill always be 
asked about the reason(s) and the presence of any adverse events.  If possible, the patient will 
be seen and assessed by an investigator(s).  Adverse events will be followed up until SFU, 
28to 35days after the last dose of study therapy (See Section 6).  Any AEs that are 
unresolved at the patient’s last AE assessment in the study are followed up by the investigator 
for as long as medically indicated, but without further recording in the CRF.
3.9.1.Procedures for discontinuation of a patientfrom investigational product 
3.9.1.1.Discontinuations Due to Safety
Assessments and Procedures: A patient who is prematurely discontinued from study therapy 
administration for safety reasons should have EOT assessments conducted per Section 
4.2.5and undergo subsequent assessments at TOC and SFU.
Clinical Outcome Assessment: If a patient is prematurely discontinued from study therapy due 
to an AE and the clinical signs and symptoms of sepsis have resolved completely or improved 
such that no further antibacterial therapy is necessary, the patient should be assessed as a 
clinical cure at EOT and reassessed at TOC.
If a patient is prematurely discontinued from study therapy due to astudy therapy-related AE 
and requires alternative non-study antibacterial for treatment for LOS, the patient should be 
assessed as a clinical failure.
Reasons for premature discontinuation from study therapy administration due to safety may 
include, but are not limited to, occurrence of an AE that, in the opinion of the investigator, 
warrants the patient’s permanent discontinuation from study therapy administration.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
29(88)
3.9.1.2.Discontinuations Due to Insufficient Therapeutic Effect
Assessments and Procedures: A patient who is prematurely discontinued from study therapy 
administration due to insufficient therapeutic effect should have EOT assessments conducted 
per Section 4.2.5and undergo subsequent safety assessments at TOC and SFU.
If a patient is discontinued from study therapy administration due to insufficient therapeutic 
effect and is switched to an alternative IV antibiotic, that therapy should be documented.
Clinical Outcome Assessment: A patient who is prematurely discontinued from study therapy 
administration (at any time after the required minimum treatment duration of 48hours) due to 
insufficient therapeutic effect should be assessed as a clinical failure on the day of 
discontinuation (ie, EOT).  Such a patient will be automatically assigned an outcome of 
clinical failure at all subsequent evaluation time points.
Reasons: Reasons for discontinuation from study therapy administration due to insufficient 
therapeutic effect may include, but are notlimited to, the following:
Clinical Worsening: A patient who shows signs of clinical worsening may be 
discontinued from study therapy administration at any time.  If the investigator deems 
the benefit-to-risk ratio of continuing study therapy acceptable, study therapy 
administration for at least 48hours is encouraged before discontinuation
Lack of Clinical Progress: For a patient who is stable, yet does not show signs of 
improvement, the investigator is encouraged to continue study therapy administration 
at least 48hours before such a patient is assessed as a clinical failure and the patient is 
discontinued from study therapy
Resistant Pathogen(s): If an organism resistant to one or more of the components of 
study therapy is isolated, the investigator will determine whether the patient remains 
on study therapy.  If clinical improvement is observed in the setting of a resistant 
isolate, the patient may be kept on study therapy at the discretion of the investigator.  
Treatment with the study therapy should be discontinued if the patient develops a 
concomitant bacterial infection with an organism that is not susceptible to the study 
therapy and requires further parenteral therapy
CNS Infection, Osteomyelitis, Endocarditis, or NEC: At Baseline, the investigator
should use clinical judgment to determine whether an imaging study is indicated to 
rule out the presence of CNS infection (eg, meningitis, brain abscess, or subdural 
abscess), osteomyelitis, endocarditis, or NEC.  If the patient is diagnosed with any of 
these conditions after enrolment into the study, the Medical Monitor should be 
notified, and the patient should be discontinued from study therapy, appropriately 
treated per standard of care, and be assessed as indeterminate.
If a patientis withdrawn from study, see Section 3.10.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
30(88)
3.10.Criteria for withdrawal 
Assessments and Procedures: A patient may be withdrawn from the study at the request of his 
or her parent(s), legally-acceptable representative(s), the investigator, or Sponsor.  A patient 
who is withdrawn completely from this study should be encouraged to undergo, if possible, 
EOT assessments per Section 4on the day of withdrawal.  Patients withdrawn from the study 
need not undergo subsequent TOC efficacy assessments.
Clinical Outcome Assessment: Patients who are withdrawn from the study and have not been 
assessed as clinical failure should be assessed as indeterminate for all remaining scheduled 
clinical assessments.
Reason(s) for withdrawal from the study may include, but are not limited to, the following:
Lost to follow-up
Withdrawal of consent
Significant patient noncompliance, as judged by the investigator, defined as 
parent(s)/legally-acceptable representative(s) refusal or inability to adhere to study 
procedures
Investigator determination that it is in the best interest of the patient to withdraw from 
the study, due to reasons other than an AE.
The investigator is encouraged to discuss with the Medical Monitor any extenuating 
circumstance that led to or may lead to withdrawal.
If a subject does not return for a scheduled visit, every effort should be made to contact the 
subject.All attempts to contact the subject and information received during contact attempts 
must be documented in the subject’s source documentation.  In any circumstance, every effort 
should be made to document subject outcome, if possible.  The investigator should inquire 
about the reason for withdrawal, request that the subject return for a final visit, if applicable, 
and follow up with the subject regarding any unresolved adverse events (AEs).
3.10.1.Screen failures 
Screenfailures are patients who do not fulfil the eligibility criteria for the study, and therefore 
must not be included in the study.  These patients should have the reason for study withdrawal 
recorded as ‘Incorrect Enrolment’ (ie, patient does not meet the required inclusion/exclusion 
criteria).  This reason for study withdrawal is only valid for screen failures. 
Where a patient is incorrectly started on treatment the patient may continue or discontinue 
treatment, depending on the outcome of the discussion between the Sponsorstudy 
physician/designee and the investigator.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
31(88)
3.10.2.Withdrawal of the informed consent
A parent/legally-acceptable representative is free to withdraw their child from the study at any 
time (IP and assessments), without prejudice to further treatment.
A parent/legally-acceptable representative who withdraws consent will always be asked about 
the reason(s) and the presence of any adverse events (AE).  The investigator will follow up 
AEs outside of the clinical study. 
Ifthe parent/legally-acceptable representative also withdraws consent for disclosure of future 
information, no furtherevaluations should be performed, and no additional data should be 
collected.  The sponsor may retain and continue to use any data collected before such 
withdrawal of consent.
If a parent/legally-acceptable representative withdraws their child from participation in the 
study, then the child
's enrolment code cannot be reused.  Withdrawn patients will be replaced.
3.11.Discontinuation of the study
The study may be stopped if, in the judgment of the Sponsor, trial patients are placed at undue 
risk because of clinically significant findings that:
Meet individual stopping criteriaor are otherwise considered significant 
Are assessed as causally related to study drug, 
Are not considered to be consistent with continuation of the study
Regardless of the reason for termination, all data available for the patientat the time of 
discontinuation of follow-up must be recorded in the Case Report Form (CRF). All reasons 
for discontinuation of treatment must be documented.
In terminating the study, the Sponsor will ensure that adequate consideration is given to the 
protection of the patients’ interests.
3.12.Sponsor’s Qualified Medical Personnel
The contact information for the sponsor
's appropriately qualified medical personnel for the 
study is documented in thestudy contact list located in the Investigator File. 
To facilitate access to appropriately qualified medical personnel on study-related medical 
questions or problems, subject’s parent(s)/legal guardian/legally acceptable representative are 
provided with a contact card.Thecontact card contains, at a minimum, protocol and 
investigational product identifiers, subject study numbers, contact information for the 
investigator site, and contact details for a contact center in the event that the investigator site 
staff cannot be reached to provide advice on a medical question or problem originating from 
another healthcare professional not involved in the subject’s participation in the study.  The 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
32(88)
contact number can also be used by investigator staff if they are seeking advice on medical 
questions or problems; however, it should be used only in the event that the established 
communication pathways between the investigator site and the global study team are not 
available.  It is therefore intended to augment, but not replace, the established communication 
pathways between the investigator site and the global study team for advice on medical 
questions or problems that may arise during the study.The contact center contact number is 
not intended for use by the subject’s parent(s)/legal guardian/legally acceptable representative
directly; if a subject’s parent(s)/legal guardian/legally acceptable representative calls that 
number, he or she will be directed back to the investigator site.
4.STUDY PLAN AND TIMING OF PROCEDURES
Study Day 1will start at the onset of study therapy and will end 24hours later.  Subsequent 
Study Days are to follow the same pattern.  Any time reference to a Study Day within the 
protocol is to be calculated in reference to the given Study Day at the time of onset ofthe first 
dose of study therapy (eg, within 24hours of Day 3means the period starting 24hours before 
Day 3at the onset time of study therapy up to 24hours after Day 3at the onset time of study 
therapy).
Procedures will be performed according to the Study Plan located in Table 1.  The 
assessments and procedures should be conducted in person by the investigator or designee, 
unless otherwise indicated.
Results from any protocol-specified evaluations already performed locally aspart of the 
patient’s regular medical care can be recorded on the CRFs and do not have to be repeated for 
purposes of this study, as follows:
Baseline clinical, laboratory, and microbiological tests: if performed within 36hours 
of the first dose of studytherapy
Baseline chest radiograph (CXR), computed tomography (CT) scans, or other imaging 
tests: if performed as part of the patient’s regular medical care within 72hours of the 
first dose of study therapy 
After Baseline, any protocol-specified evaluations:  if performed within 24hours of 
any study day.
Table 1provides an overview of the protocol visits and procedures.  Refer to the Study 
Assessments section of the protocol for detailed information on each procedure and 
assessment required for compliance with the protocol. 
The investigator may schedule visits (unplanned visits) in addition to those listed on the 
schedule of activities table, in order to conduct evaluations or assessments required to protect 
the well-being of the subject.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
33(88)
Table 1
Study Plan detailing the procedures
Assessment or Procedure
Baselinea
Treatment period
Follow-up
Study Days*
1 2 3 4-14 EOTb TOCc SFUd
Written informed consent
X
Inclusion/exclusion criteria
e
X
Clinical
Medical history (including 
antepartum/peripartum period)
X
Adverseeventreview(AEsandSA
Es)
X 
X X X X 
X 
X 
X
Prior and concomitant medicationsf
X 
X X X X 
X 
X 
X
Length
X
Weight
X 
X X X X 
X 
X 
X
Physical examination
X 
X X X X 
X 
X
Vital signsand oxygen saturationg
X 
X X X X 
X 
X 
X
Clinical outcome
X 
X
Record adjunctive therapeutic 
procedures (if performed)
X X X X 
X 
X
CXR, CT scan, or other imaging 
tests
h
Xj
Laboratory
CBC with differentiali
X
Xj
X 
Xj
Xj
Chemistry panel
i
X
Xj
X 
Xj
Xj
Base excess
Xj
CRP and Procalcitonini
Xj
Urinalysis
X
Xj
X 
Xj
Urine output
Xk
X X X 
Xj
CSF
Xj
PK
Assignment to PK schedulel
X
PK blood samplem
X
CSF sample (if collected per 
standard of care) & matching blood 
sample
n
X
Micro
Blood culture
Xj
Urine culture
Xj
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
34(88)
CSF culture
Xj
Other specimen or tissue cultures
Xj
Administration of study therapy
X X X X 
X
* Study Day 1 will start at the onset of study therapy and will end 24 hours later.  Subsequent Study Days are to 
follow the same pattern.
Abbreviations: AEs=adverse events; CBC=complete blood count; CRP=C-reactive protein; CSF=cerebrospinal 
fluid; CT=computed tomography; CXR=chest radiograph; EOT=End-of-Therapy; MRI=magnetic resonance 
imaging; PK=pharmacokinetic; SAEs=serious adverse events; SFU=Safety Follow-up; TOC=Test-of-Cure.
a. Conduct Baseline assessments within 36hours before first dose of study therapy.
b. Conduct EOT assessments within 24hours after the end of last infusion.  Study therapy may or may not be 
given on the same calendar day as EOT assessments; administration should be as for days 4-14.
c. Conduct TOC assessments 8to 15days after the last dose of study therapy.
d. Conduct SFU assessments, preferably in person, 28to 35days after the last dose of study therapy.  The SFU 
may be conducted via telephone for any patientwho has not experienced clinical relapse, did not have ongoing 
AEs or SAEs at TOC, or did not develop AEs or SAEs since TOC.  If symptoms of relapse or new AEs or 
SAEs are noted, or at the discretion of the investigator, the patientshould be immediately scheduled for an 
in-personvisit.  If the visit is in-person, weight, vital signs and oxygen saturation should be recorded.  If a 
patientwas previously assessed as a clinical failure, only safety assessments will be performed.
e. Refer tothe inclusion criteria (Section 3.1) for the recommended definitions of clinical and laboratory 
inclusion criteria.
f. For patients who are being breast fed, record all medications taken by the lactating mother for 3days before 
first dose of study therapy through SFU.
g. Postbaseline, record highest and lowest postdose temperature measurements.
h. At baseline, obtain results of CXR, CT scan, or other imaging tests (eg, echocardiogram, CT, MRI, 
sonography) if performed as part of the patient’s regular medical care within 72hours before first dose of 
study therapy.
i. Refer tothe inclusion criteria (Section 3.1) for list of tests.  Recommended to repeat at least every 7days.  If 
immature neutrophils are available, calculate I/T neutrophil ratio using the formula: I/T ratio=Immature 
cells/Total (mature+immature).
j. If clinically indicated.
k. For patients who have been hospitalized for ≥8hours, calculate urine output over the last 8-hour period.
l. Patients will be randomly assigned (1:1) to one of the following PK sample collection schedules collected after 
any dose between the end of the 4th infusion of ceftaroline fosamil and before EOT or Study Day 
14(whichever is earlier):
PK Schedule 1: at the end of the ceftaroline fosamil infusion (± 5minutes) and 3to 4hours after the end of the 
infusion
PK Schedule 2: 15minutes to 2hours after the end of theceftaroline fosamil infusion and 5to 7hours after the 
end of the infusion (before the start of the next infusion).
m. PK blood samples are NOT to be drawn if the patientreceived a blood or blood component transfusion within 
the past 24hours.  For patients who are at risk from additional blood loss, collection of PK samples will 
require assessment by the investigator.
n. Matching blood sample to be collected only if 2PK blood samples have not been collected already.  The 
matching blood sample replaces one ofthe PK samples, so that the total number of PK samples does not 
exceed 2.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
35(88)
4.1.Baseline
Informed consent in writing will be obtained from parent(s) or legally-acceptable
representative(s) before initiating any study assessment or procedure.
Baseline procedures must be completed within 36hours before the start of the first dose of 
study therapy.  If any such procedures have been carried out as standard-of-care within the 
timeframe they can be considered as baseline procedures.  Potential patients who do not meet 
entrance criteria may, as appropriate, repeat Baseline evaluations at a later time for possible 
enrolment into the study. 
4.1.1.Baseline assessments
4.1.1.1.Clinical assessments
Obtain a complete medical and surgical history, including, but not limited to, history 
of delivery, antepartum and peripartum antibacterials, vaccinations, congenital 
abnormalities, and all active conditions and all conditions diagnosed after birth
Identify, assess, and record any AEs and SAEs starting from the time that informed 
consent is obtained
Record prior medications (Section 7.7) taken or received within 7days before the first 
dose of study therapy.  For children who are being breast fed, record all medications 
taken by the lactating mother during the 3days before the first dose of study therapy.
Record the findings of a complete physical examination, including, but not limited to:
Physical findings of LOS
Presence of central venous catheter (eg, umbilical catheter); evaluate the 
possibility of catheter-related sepsis (CRS) and if CRS is suspected, remove the 
catheter when it is safe and clinically feasible 
Presence of other medical devices such as ventilator, cardiac devices, CSF 
shunts, orthopedic transplants, or urinary catheter
Record weight and length
Record vital signs (heart rate/pulse, blood pressure, respiratory rate, temperature) and 
oxygen saturation
Record at least 2heart rate/pulse measurements taken during a 30minute 
period
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
36(88)
Record at least 2blood pressuremeasurements, or record highest and lowest 
measurements if continuously monitored, over a 30minute period
Record CXR or chest CT scan results if performed as part of the patient’s regular 
medical care within 72hours before the start of the first dose ofstudy therapy
Record other imaging study results (eg, echocardiogram, CT, MRI, sonography) if 
performed as part of the patient’s regular medical care within 72hours before the start 
of the first dose of study therapy.
4.1.1.2.Laboratory assessments
Obtain blood samples for complete blood count (CBC) with differential and chemistry 
panel (see Laboratory Manual)
If blood gases are available, calculate base excess (BE) using the formula: 
BE=0.9287(HCO324.4+ 14.83(pH -7.4))
Record CRP and serum procalcitonin levels if tests are performed as part of the 
patient’s regular medical care
Perform urinalysis (see Laboratory Manual)
For patients who have been hospitalized for ≥8hours, calculate urine output over the 
last 8-hour period
If clinically indicated and performed as part of patient’s regular medical care, obtain 
CSF sample.
4.1.1.3.Microbiological assessments  
Microbiological assessments should be performed preferably before any antibiotics are 
administered.
If clinically indicated and performed as part of patient’s regular medical care, obtain 
blood and urine samples for testing per Section 5.2.1and 5.2.2, respectively; cultures 
should be repeated per standard of care upon knowledge of a positive result until 
sterilization is confirmed
If clinically indicated and performed as part of patient’s regular medical care, obtain 
CSF or other specimens/tissue samples per Section 5.2.3and 5.2.4, respectively; 
cultures may be repeated per standard of care upon knowledge of a positive result.
Obtain any prior microbiological and clinical data (eg, notes in medical records 
confirming worsening of signs and symptoms of sepsis) that may help determine 
eligibility (Section 5.2)
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
37(88)
Enrol the patient and assign to PK schedule after verifying that the patient meets all inclusion 
and no exclusioncriteria.  There should be no medically inappropriate delay in administration 
of study therapy.
4.2.Treatment period
Procedures for this period will be performed according to the schedule outlined in the Study 
Plan (Table 1) and thefollowing are descriptions of specific requirements for the treatment 
period:
4.2.1.Study Day 1(starts with onset of study drug administration)
Study Day 1is the 24-hour period starting at the onset of the first administration of study 
therapy.  Baseline assessments may be conducted within 36hours before the onset of study 
therapy; therefore, Study Day 1procedures described below are to be conducted within 
24hours of the onset of study therapy.
4.2.1.1.Study therapy administration
Ceftaroline fosamil, IV: 6mg/kg IV over 60(± 10) minutes q8h (±1hour).  The dose 
should be calculated based on the patient’s first weight of the day.
Ampicillin, IV: if mandated as per Section 7.2.2; dosage per institutional guidelines
Optional aminoglycoside, IV: choice of aminoglycoside and dosage per institutional 
guidelines and investigator’s judgment.  Gentamicin is preferred. 
4.2.1.2.Clinical assessments -after at least 1dose of study therapy
Identify, assess, and record any new or ongoing AEs or SAEs
Record concomitant medications (Section 7.7).  For patients who are being breast fed, 
record all medications taken by the lactating mother.
Record the findings of a complete physical examination, including, but not limited to, 
physical findings of LOS, presence of central venous catheter or other medical devices 
(if applicable)
Record the patient’s first weightof the day
Record vital signs (heart rate/pulse, blood pressure, respiratory rate, temperature) and 
oxygen saturation; record highest and lowest postdose temperature measurements
Record adjunctive therapeutic procedures (eg, drainage of foci of infection), if 
performed
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
38(88)
If clinically indicated, obtain resultsof CXR, CT scan, or other imaging tests 
performed as part of the patient’s regular medical care.
4.2.1.3.Laboratory assessments -after at least 1dose of study therapy
If clinically indicated, obtain blood samples for CBC with differential and chemistry 
panel (see Laboratory Manual)
If blood gases are available, calculate BE
If clinically indicated, obtain CRP and serum procalcitonin levels
If clinically indicated, perform urinalysis (see Laboratory Manual)
For patients who have been hospitalized for ≥8hours, calculate urine output over the 
last 8-hour period
If clinically indicated and performed as part of patient’s regular medical care, obtain 
CSF sample.
4.2.1.4.Microbiological assessments -after at least 1dose of study therapy
If clinically indicated and performed as part of patient’s regular medical care, obtain 
blood and urine samples for testing per Section 5.2.1and 5.2.2, respectively; cultures 
should be repeated per standard of care upon knowledge of a positive result until 
sterilization is confirmed.
If a lumbar puncture (or any CSF sample collection) is performed after the first 
infusion of ceftaroline fosamil, a matching PK blood sample should be drawn at the 
time ofCSF collection (± 5minutes).  This PK blood sample will replace the closest 
corresponding PK blood sample based on the PK times described above.
If clinically indicated and performed as part of patient’s regular medical care, obtain 
CSF or other specimens/tissue samples per Section 5.2.3and 5.2.4, respectively; 
cultures may be repeated per standard of care upon knowledge of a positive result.
4.2.2.Study Day 2(starts 24hours after onset of study drug administration)
4.2.2.1.Study therapy administration
Ceftaroline fosamil, IV: 6mg/kg IV over 60(± 10) minutes q8h (±1hour). The dose 
should be calculated based on the patient’s first weight of the day.
Ampicillin, IV: if mandated as perSection 7.2.2; dosage per institutional guidelines
Optional aminoglycoside, IV: choice of aminoglycoside and dosage per institutional 
guidelines and investigator’s judgment.  Gentamicin is preferred. 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
39(88)
4.2.2.2.Clinical assessments -any time during study day
Identify, assess, and record any new or ongoing AEs and SAEs
Record concomitant medications (Section 7.7).  For patients who are being breast fed, 
record all medications taken by the lactating mother
Record the findings of a complete physical examination, including, but not limited to, 
physical findings of LOS, presence of central venous catheter or other medical devices 
(ifapplicable)
Record the patient’s first weightof the day
Record vital signs (heart rate/pulse, blood pressure, respiratory rate, temperature) and 
oxygen saturation; record highest and lowest daily temperature measurements
Record adjunctive therapeutic procedures (eg, drainage of foci of infection), if 
performed
If clinically indicated, obtain results of CXR, CT scan, or other imaging tests 
performed as part of the patient’s regular medical care.
4.2.2.3.Laboratory assessments -any time during study day
If clinically indicated, obtain blood samples for CBC with differential and chemistry 
panel (see Laboratory Manual)
If blood gases are available, calculate BE
If clinically indicated, obtain CRP and serum procalcitonin levels 
If clinically indicated, perform urinalysis (see Laboratory Manual)
Calculate urine output over the last 8-hour period
If clinically indicated and performed as part of patient’s regular medical care, obtain 
CSF sample.
4.2.2.4.PK procedures
Do not draw PK blood samples if the patient received a blood or blood component 
transfusion within the past 24hours.  For patients who are at risk from additional 
blood loss, collection of PK samples will require assessment by the investigator.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
40(88)
Obtain 2PK blood samples after any infusion of ceftaroline fosamil, between the end 
of the fourth infusion and before EOT or Study Day 14(whichever is earlier), 
according to the patient’s assigned PK schedule shown below:
PK Schedule 1
At the end of the ceftaroline fosamil infusion (± 5minutes)
3to 4hours after the end of the infusion
PK Schedule 2
15minutes to 2hours after the end of the ceftaroline fosamil infusion
5to 7hours after the end of the infusion (before the start of the next 
infusion)
If a lumbar puncture (or other CSF sample collection) is expected and the 2PK blood 
samples have not been collected, the time of one of the PK blood samples should be 
adjusted to correspond to the time of the lumbar puncture; the total number of PK 
blood samples collected will not exceed 2.
After the 2PK blood samples have been collected, any portion of a CSF sample 
(collected as part of standard of care) not required for the patient’s medical care should 
be retained for PK analysis.
4.2.2.5.Microbiological assessments -any time during study day
If clinically indicated and performed as part of patient’s regular medical care, obtain 
blood and urine samples for testing per Section 5.2.1and 5.2.2, respectively; cultures 
should be repeated per standard of care upon knowledge of a positive result until 
sterilization is confirmed.
If clinically indicated and performed as part of patient’s regular medical care, obtain 
CSF or other specimens/tissue samples per Section 5.2.3and 5.2.4, respectively; 
cultures may be repeated per standard of care upon knowledge of a positive result.
4.2.3.Study Day 3(starts 48hours after onset of study drug administration)
4.2.3.1.Studytherapy administration
Ceftaroline fosamil, IV: 6mg/kg IV over 60(± 10) minutes q8h (±1hour).  The dose 
should be calculated based on the patient’s first weight of the day.
Ampicillin, IV: dosage per institutional guidelines (after 48hours, the duration of 
treatment with ampicillin is at the discretion of the investigator)
Optional aminoglycoside, IV: choice of aminoglycoside and dosage per institutional 
guidelines and investigator’s judgment.  Gentamicin is preferred. 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
41(88)
4.2.3.2.Clinical assessments -any timeduring study day
Identify, assess, and record any new or ongoing AEs and SAEs
Record concomitant medications (Section 7.7).  For patients who are being breast fed, 
record all medications taken by the lactating mother
Record the findings of a complete physical examination, including, but not limited to, 
physical findings of LOS, presence of central venous catheter or other medical devices 
(if applicable)
Record the patient’s first weightof theday
Record vital signs (heart rate/pulse, blood pressure, respiratory rate, temperature) and 
oxygen saturation; record highest and lowest daily temperature measurements
Record adjunctive therapeutic procedures (eg, drainage of foci of infection), if 
performed
If clinically indicated, obtain results of CXR, CT scan, or other imaging tests 
performed as part of the patient’s regular medical care.
4.2.3.3.Laboratory assessments -any time during study day
If clinically indicated, obtain blood samples for CBC with differential and chemistry 
panel (see Laboratory Manual)
If blood gases are available, calculate BE
If clinically indicated, obtain CRP and serum procalcitonin levels
If clinically indicated, perform urinalysis (see Laboratory Manual)
Calculate urine output over the last 8-hour period
If clinically indicated and performed as part of patient’s regular medical care, obtain 
CSF sample.
4.2.3.4.Microbiological assessments -any time during study day
If clinically indicated and performed as part of patient’s regular medicalcare, obtain 
blood and urine samples for testing per Section 5.2.1and 5.2.2, respectively; cultures 
should be repeated per standard of care upon knowledge of a positive result until 
sterilization is confirmed
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
42(88)
If clinically indicated and performed as part of patient’s regular medical care, obtain 
CSF or other specimens/tissue samples per Section 5.2.3and 5.2.4, respectively; 
cultures may be repeated per standard of care upon knowledge of a positive result.
4.2.3.5.PK procedures
Do not draw PK blood samples if the patient received a blood or blood component 
transfusion within the past 24hours.  For patients who are at risk from additional 
blood loss, collection of PK samples will require assessment by the investigator.
If not previously collected, obtain 2PK blood samples after any infusion of ceftaroline 
fosamil, between the end of the fourth infusion and before EOT or Study Day 
14(whichever is earlier), according to the patient’s assigned PK schedule (see 
Section4.2.2.4for schedule and adjustment for CSF sample collection). 
4.2.4.Study Days 4through 14(starts 72hours after onset of study drug administration 
and an extra 24hours for each day thereafter)
4.2.4.1.Study therapy administration
Ceftaroline fosamil, IV: 6mg/kg IV over 60(± 10) minutes q8h (±1hour). The dose 
should be calculated based on the patient’s first weight of the day.
Ampicillin, IV: dosage per institutional guidelines (after 48hours, the duration of 
treatment with ampicillin is at the discretion of the investigator)
Optional aminoglycoside, IV: choice of aminoglycoside and dosage per institutional 
guidelines and investigator’s judgment.  Gentamicin is preferred. 
4.2.4.2.Clinical assessments -any time during study day
Identify, assess, and record any new or ongoing AEs and SAEs
Record concomitant medications (Section 7.7).  For patients who are being breast fed, 
record all medications taken by the lactating mother
Record the findings of a complete physical examination, including, but not limited to, 
physical findings of LOS, presence of central venous catheter or other medical devices 
(if applicable)
Record the patient’s first weight of the day, daily
Record vital signs (heart rate/pulse, blood pressure, respiratory rate, temperature) and 
oxygen saturation; record highest and lowest daily temperature measurements
Record adjunctive therapeutic procedures (eg, drainage of foci of infection), if 
performed 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
43(88)
If clinically indicated, obtain results of CXR, CT scan, or other imaging test performed 
as part of the patient’s regular medical care.
4.2.4.3.Laboratory assessments -any time during study day
If clinically indicated, obtain blood samples for CBC with differential and chemistry 
panel (see Laboratory Manual); recommended to repeat CBC with differential and 
chemistry panel at least every 7days
If blood gases are available, calculate BE
If clinically indicated, obtain CRP and serum procalcitonin levels
If clinically indicated, perform urinalysis (see Laboratory Manual) and calculate urine 
output over the last 8-hour period
If clinically indicated and performed as part of patient’s regular medical care, obtain 
CSF sample.
4.2.4.4.Microbiological assessments -any time during study day
If clinically indicated and performed as part of patient’s regular medical care, obtain
blood and urine samples for testing per Section 5.2.1and 5.2.2, respectively; cultures 
should be repeated per standard of care upon knowledge of a positive result until 
sterilization is confirmed
If clinically indicated and performed as part of patient’s regular medical care, obtain 
CSF or other specimens/tissue samples per Section 5.2.3and 5.2.4, respectively; 
cultures may be repeated per standard of care upon knowledge of a positive result.
4.2.4.5.PK procedures
Do not draw PK blood samples if the patient received a blood or blood component 
transfusion within the past 24hours. For patients who are at risk from additional 
blood loss, collection of PK samples will require assessment by the investigator.
If not previously collected, obtain 2PK blood samples after any infusion of ceftaroline 
fosamil, between the end of the fourth infusion and before EOT or Study Day 
14(whichever is earlier), according to the patient’s assigned PK schedule (see 
Section4.2.2.4for schedule and adjustment for CSF sample collection)
4.2.5.End-of-Therapy (EOT)
Conduct EOT assessments within 24hours after administration of the last dose of study 
therapy.  Conduct the EOT assessments in place of the regular study visit (eg, Study Days 4to 
≤14) assessments that would have been performed the day of that visit.  If applicable, refer to 
guidance on whento end study therapy in Section 3.9.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
44(88)
If applicable, as study therapy may or may not be given on the same calendar day as EOT 
assessments, administer studytherapy as described in Section 4.2.4.
4.2.5.1.Clinical assessments -after the last dose of study therapy
Identify, assess, and record any new or ongoing AEs and SAEs
Record concomitant medications (Section 7.7).  For patients who are being breast fed, 
record all medications taken by the lactating mother
Record the findings of a complete physical examination, including,but not limited to, 
physical findings of LOS; presence of central venous catheter or other medical devices 
(if applicable)
Record weight 
Record vital signs (heart rate/pulse, blood pressure, respiratory rate, temperature) and 
oxygen saturation; record highest and lowest daily temperature measurements
Assess clinical outcome (per Table 5, Section 8.4.1)
Record adjunctive therapeutic procedures (eg, drainage of foci ofinfection), if 
performed 
If clinically indicated, obtain results of CXR, CT scan, or other imaging test performed 
as part of the patient’s regular medical care.
4.2.5.2.Laboratory assessments -after the last dose of study therapy
Obtain blood samples for CBC with differential and chemistry panel (see Laboratory 
Manual)
If blood gases are available, calculate BE
If clinically indicated, obtain CRP and serum procalcitonin levels
Perform urinalysis (see Laboratory Manual)
If clinically indicated, calculate urinary output over the last 8-hour period
If clinically indicated and performed as part of patient’s regular medical care, obtain 
CSF sample.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
45(88)
4.2.5.3.Microbiological assessments -after the last dose of study therapy
If clinically indicated and performed as part of patient’s regular medical care, obtain 
blood and urine samples for testing per Section 5.2.1and 5.2.2, respectively; cultures 
should be repeated per standard of care upon knowledge of a positive result until 
sterilization is confirmed
If clinically indicated and performed as part of patient’s regular medical care, obtain 
CSF or other specimens/tissue samples per Section 5.2.3and 5.2.4, respectively; 
cultures may be repeated per standard of care upon knowledge of a positive result.
4.3.Follow-up period
Procedures for this period will be performed according to the schedule outlined inthe Study 
Plan (Table 1) and the following are descriptions of specific requirements for the Follow-up 
period: 
4.3.1.Test-of-Cure (TOC)
Conduct TOC assessments 8to 15days after administration of the last dose of study therapy.
4.3.1.1.Clinical assessments
Identify, assess, and record any new or ongoing AEs and SAEs
Record concomitant medications (Section 7.7).  For patients who are being breast fed, 
record all medications taken by the lactating mother
Record the findings of a complete physical examination, including, but not limited to, 
physical findings of LOS, presence of central venous catheter or other medical devices 
(if applicable)
Record weight
Record vital signs (heart rate/pulse, blood pressure, respiratory rate, temperature) and 
oxygen saturation; record highest and lowest daily temperature measurements
Assess clinical outcome (per Table 5, Section 8.4.1)
Record adjunctive therapeutic procedures (eg, drainage of foci of infection), if 
performed
If clinically indicated, obtain results of CXR, CT scan, or other imaging tests 
performed as part of the patient’s regular medical care; if test was performed after 
EOT but before TOC, record the latest result.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
46(88)
4.3.1.2.Laboratory assessments
If clinically indicated, obtain blood samples for CBC with differential and chemistry 
panel (see Laboratory Manual)
If clinically indicated, perform urinalysis (see Laboratory Manual)
If clinically indicated, calculate urinary output over the last 8-hour period
If clinically indicated and performed as part of patient’s regular medical care, obtain 
CSF sample.
4.3.1.3.Microbiological assessments
If clinically indicated and performed as part of patient’s regular medical care, obtain 
blood and urine samples for testing per Section 5.2.1and 5.2.2, respectively; cultures 
should be repeated per standard of care upon knowledge of a positive result until 
sterilization is confirmed
If clinically indicated and performed as part of patient’s regular medical care, obtain 
CSF or other specimens/tissue samples per Section 5.2.3and 5.2.4, respectively; 
cultures may be repeated per standard of care upon knowledge of a positive result.
If a patient was previously assessed as a clinical failure, perform only safety assessments (ie, 
AEs and SAEs, concomitant medications, weight, vital signs, CBC with differential, 
chemistry panel).
4.3.2.Safety Follow-Up (SFU)
Conduct SFU assessments, preferably in person, 28to 35days after the last dose of study 
therapy.  The SFU may be conducted via telephone for any patient who has not experienced 
clinical relapse, did not have ongoing AEs or SAEs at TOC, or did not develop AEs or SAEs 
since TOC.  If symptoms of relapse or new AEs or SAEs are noted, or at the discretion of the 
investigator, the patient should be immediately scheduled for an in-person visit.  If a patient 
was previously assessed as a clinical failure, only safety assessments should be performed.
4.3.2.1.If SFU conducted via telephone
Record concomitant medications (Section 7.7).  For patients who are being breast fed, 
record all medications taken by the lactating mother
Identify, assess, and record any new or ongoing AEs or SAEs.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
47(88)
4.3.2.2.If SFU conducted in person
Clinical assessments
Identify, assess, and record any new or ongoing AEs or SAEs
Record concomitant medications (Section 7.7).  For patients who are being breast fed, 
record all medications taken by the lactating mother
Record weight
Record vital signs (heart rate/pulse, blood pressure, respiratory rate, temperature) and 
oxygen saturation; record highest and lowest daily temperature measurements.
Laboratory assessments
If clinically indicated, obtain blood samples for CBC with differential and chemistry 
panel (see Laboratory Manual).
5.STUDY ASSESSMENTS
Every effort should be made to ensure that the protocol-required tests and procedures are 
completed as described.  However, it is anticipated that fromtime to time there may be 
circumstances outside of the control of the investigator that may make it unfeasible to perform 
the test.  In these cases the investigator will take all steps necessary to ensure the safety and 
well-being of the subject.  When a protocol-required test cannot be performed, the investigator 
will document the reason for this and any corrective and preventive actions that he or she has 
taken to ensure that normal processes are adhered to as soon as possible.  The global study 
team will be informed of these incidents in a timely manner.
For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior to 
initiation of the study.
The investigator will ensure that data are recorded on the CRF as specified in the study 
protocol and in accordance with the CRF completion instructions provided.
The investigator ensures the accuracy, completeness, and timeliness of the data recorded and 
of the provision of answers to data queries according to the Clinical Study Agreement (CSA).  
The investigator will sign the completed CRF.  A copy of the completed CRF will be archived 
at the study site.
5.1.Efficacy assessments
Efficacy outcome measures will include clinical outcome at EOT and TOC in the Modified 
Intent-to-Treat (MITT) Analysis Set.  Clinical outcome will be assessed by the investigator 
Categories of clinical outcome are described in Section 8.4.1.1and 8.4.1.2.  A favourable 
clinical outcome is clinical cure.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
48(88)
5.2.Microbiological assessments
5.2.1.Blood sample for culture
If clinically indicated and performed as part of patient’s regular medical care, obtain blood for 
culture at Baseline (preferably before any antibiotics are administered) and at any time 
through TOC.  Cultures should be repeated per standard of care upon knowledge of a positive 
result until sterilization is confirmed.  Perform culture and organism identification at the local 
or regional laboratory, as applicable.  Send all isolates to the central laboratory for organism 
identification and susceptibility testing.
Refer to the study-specific clinical and microbiology laboratory manual for specific 
procedures pertaining to the collection, processing, storage, and shipment of blood culture or 
isolates.
This protocol complies with European Union’s recommendations for blood loss associated 
with pediatricresearch
3and the World Health Organization guidelines “Blood Sample 
Volumes in Child Health Research: Review of Safe Limits”.
6  To minimize risk from blood 
loss associated with this study, standard of care laboratory results will be used whenever 
possible.  All safety laboratory tests will be limited to local processing.  In addition, pediatric
blood collection tubes will be used and capillary method of blood draw will be implemented 
whenever feasible.  PK samples will be collected from patients unless deemed unsafe due to 
the risk from additional blood loss (per the investigator’s judgment).
5.2.2.Urine sample for culture
If clinically indicated and performed as part of patient’s regular medical care, obtain urine for 
culture as clinically indicated at Baseline (preferably before any antibiotics are administered) 
and at any time through TOC.  Cultures should be repeated per standard of care upon 
knowledge of a positive result until sterilization is confirmed.  Perform Gram stain, culture, 
and organism identification at the local or regional laboratory, as applicable.  Send all isolates 
to the central laboratory for organism identification and susceptibility testing.
Refer to the study-specific clinical and microbiology laboratory manual for specific 
procedures pertaining to the collection, processing, storage, and shipment of urine culture or 
isolates.
5.2.3.Cerebrospinal fluid for culture
If clinically indicated and performed as part of patient’s regular medical care, obtain CSF for 
culture and/or PCR as clinically indicated at Baseline (preferably before any antibiotics are 
administered) and at any time through TOC.  Cultures may be repeated per standard of care 
upon knowledge of a positive result.  Perform Gram stain, culture/PCR, and organism 
identification at the local or regional laboratory, as applicable.  Send all isolates to the central 
laboratory for organism identification and susceptibility testing.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
49(88)
Refer to the study-specific clinical and microbiology laboratory manual for specific 
procedures pertaining to the collection, processing, storage, and shipment of CSF culture or 
isolates.
5.2.4.Other specimens and tissue samples for culture
If clinically indicated and performed as part of patient’s regular medical care, obtainother 
specimen and tissue samples from potential foci of infection for culture as clinically indicated 
at Baseline (preferably before any antibiotics are administered) and at any time through TOC.  
Cultures may be repeated upon knowledge of a positive result, if obtained per standard of 
care.  Perform Gram stain (if applicable), culture, and organism identification at the local or 
regional laboratory.  Send all isolates to the central laboratory for organism identification and 
susceptibility testing.
Referto the study-specific microbiology and clinic laboratory manual for specific procedures 
pertaining to the collection, processing, storage, and shipment of other specimens/tissues for 
culture or isolates.
5.3.Safety assessments
Patients must be evaluated by a physician or an appropriately trained health care professional 
at every visit, and the evaluation must be documented.  The procedures discussed below will 
be completed at the designated visits.
5.3.1.Laboratory safety assessments
Blood samples and urine samples will be collected according to the study plan (Table 1) at 
baseline and EOT.  Samples may also be collected at any time during the treatment period, at 
TOC and SFU if clinically indicated.
The following laboratory variables will be measured: 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
50(88)
Table 2 
Laboratory Safety Variables
Chemistry panel
CBC and differential
Urinalysis
Albumin
Haematocrit
Urinalysis will be done
Alkaline phosphatase
Haemoglobin
Alanine aminotransferase
Red Blood Cellcount
Aspartate aminotransferase
White Blood Cell count
Bilirubin, total and direct
Eosinophils
c
Blood urea nitrogen/urea
Lymphocytesc
Calcium
Monocytesc
Chloride
Neutrophilsc
Creatininea
Neutrophils, immature
c
Glucose, nonfastinga
Platelets
Potassium
Sodium
Bicarbonate (HCO3)
b
Lactateb
pH
b
C-reactive protein
b
Procalcitoninb
a
Required for eligibility
b
Test not mandatory for eligibility if other eligibility criteria are met.
c
absolute count and/or %
If a patient’s urine output decreases to <0.5mL/kg/h (measured over at least 8hours) or serum 
creatinine level increases ≥2× ULN during the treatment period, the Medical Monitor should 
be contacted to discuss the patient’s safe continuation in the study.  If a patient’s haemoglobin 
or haematocrit decreases significantly (investigator’s judgment) during study therapy, an 
evaluation for haemolytic anaemia should be conducted per standard of care.
Scheduled and clinically indicated laboratory tests (emergency or unscheduled tests) should be 
conducted at the local or regional laboratory.
5.3.2.Other clinical assessments
Safety parameters will be monitored according to standard medical practice and guidelines for 
IV administration of study therapy. 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
51(88)
Vital sign assessments will be conducted at the specified time points outlined in the Study 
Plan(Table 1).
Medical and surgical history including antepartum/peripartum period, prior and concomitant 
medications, length, weight, and physical examination findings (including LOS physical 
findings and presence of central venous catheter or other medical devices) will be recorded at 
Baseline and, if applicable, during the study according to the Study Plan (Table 1). 
If performed, adjunctive therapeutic procedures will be recorded throughout the treatment
period until TOC.
If performed as part of the patient’s regular medical care, results of CXR, CT scan or other 
imaging tests will be obtained at Baseline, throughout the treatment period, at EOT and at 
TOC.
5.3.3.Adverse events
Adverse events will be reviewed at Baseline, throughout the Treatment Period, and at EOT, 
TOC and SFU.  AEs and SAEs are defined in Section 1.1and1.3, respectively.  AEs will be 
collected and reported as described in Section 1.1.
5.4.Pharmacokinetics
5.4.1.Collection of blood samples
Two PK blood samples (approximately 0.3to 0.6mL per draw) will be obtained at steady 
state from at least 20patients.  Patients will be randomly assigned (1:1) at the time of 
enrolment to one of the PK sample collection schedules shown below.  The PK samples may 
be collected anytime between the end of the fourth infusion of ceftaroline fosamil and before 
EOT or Study Day 14(whichever is earlier).  For patients who are at risk from additional 
blood loss, collection of PK samples will require assessment by the investigator. 
If CSF sample collection is expected per standard of care, delay any PK sample collection and 
collect it at the time of CSF collection (± 5minutes) as a matching PK blood sample.  Record 
the time of the matching PK blood sample collection.
If the 2PK blood samples have not been collected and a lumbar puncture (or any CSF sample 
collection) is performed after the first infusion of ceftaroline fosamil and within 8hours after 
the last infusion, a matching PK blood sample will be drawn at the time of CSF collection 
(±5minutes).  This PK blood sample will replace the closest corresponding PK blood sample 
based on the PK times described below.  The total number of PK blood samples collected will 
not exceed 2.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
52(88)
PK Schedule 1
At the end of the ceftaroline fosamil infusion (± 5minutes)
3to 4hours after the end of the infusion
PK Schedule 2
15minutes to 2hours after the end of the ceftaroline fosamil infusion
5to 7hours after the end of the infusion (before the start of the next 
infusion)
The PK sampling time may be adjusted by the Sponsor based on emerging data, but the total number of samples 
will not be increased.
5.4.2.Collection of cerebrospinal fluid samples
For patients who have CSF collected as part of standard of care, the remainder of any CSF 
sample obtained after the first dose of ceftaroline fosamil will be retained to compare 
ceftaroline concentrations in the CSF to those in plasma.  After the 2PK blood samples have 
been collected, any portion of a CSF sample (collected as part of standard of care) not 
required for the patient’s medical care should be retained for PK analysis.
Blood and CSF samples will be collected, labelled, stored and shipped as detailed in the 
Laboratory Manual.
5.4.3.Determination of drug concentration
Samples for determination of ceftaroline fosamil, ceftaroline, and ceftaroline M-1(inactive 
metabolite) concentrationsin plasma and any available samples for determination of 
ceftaroline and ceftaroline M-1concentrations in CSF will be analysed by Covance 
Laboratories on behalf of the Sponsor, using appropriate bioanalytical methods.  Full details 
of the analytical methods used will be described in a separate bioanalytical report.
5.4.4.Storage and destruction of pharmacokinetic samples
PK samples will be disposed of after the Bioanalytical Report finalization or 6months after 
issuance of the draft Bioanalytical Report (whichever is earlier), unless requested for future 
analyses. 
Pharmacokinetic samples may be disposed of or destroyed and anonymized by pooling.  
Additional analyses may be conducted on the anonymized, pooled PK samples to further 
evaluate and validate the analytical method.  Any results from such analyses may be reported 
separately from the CSR.
Incurred sample reproducibility analysis, if any, will be performed alongside the bioanalysis 
of the test samples.  The results from the evaluation will not be reportedin the Clinical Study 
Report (CSR) but separately in a Bioanalytical Report.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
53(88)
Any residual back-up PK samples may be used for future exploratory biomarker research (in 
this case, residual back-up PK samples will be stored at a secure laboratory designated by the 
Sponsor; see details in the Laboratory Manual).
5.5.Pharmacodynamics (not applicable)
5.6.Pharmacogenetics(not applicable)
5.7.Biomarker analysis (not applicable)
5.8.Volume of blood
Table 3shows the maximum volume of blood that will be drawn from each patient for the 
purposes of the study, apart from blood that is taken as part of patient’s normal standard of 
care.  The volume drawn for study purposes may be lower, as samples taken as standard of 
care will be used where possible.  The combined volume of all blood samples taken from a 
patientby the end of the study for investigational laboratory tests (ie, CBC with differential, 
chemistry panel, and PK analyses)is to be no more than 2.4cc/kg or 10cc total whichever is 
less.  Any deviation from this should be clinically justified.
Table 3
Volume of blood per patient
Assessment or Procedure
Baseline
Treatment period
Study Days
1 2 3 4-14
EOT TOC SFU
Laboratory
CBC with differentiala
0.5ml
0.5ml
Chemistry panela
1.2ml
1.2ml
PK
PK blood sampleb
1.2ml 
Maximum blood volume required per protocol
1.7ml
1.2ml
1.7ml
a
These samples are likely to be required per standard of care
b 2PK samples (0.6ml each) to be taken during the period from Day 2to Day 14, at the discretion of the 
investigator
6.ADVERSE EVENT REPORTING AND MEDICAL MANAGEMENT
The Principal Investigator is responsible for ensuring that all staff involved in the study are 
familiar with the content of this section.
6.1.Requirements
The table below summarizes the requirements for recording safety events on the CRF and for 
reporting safety events on the Clinical Trial (CT) Serious Adverse Event (SAE) Report Form 
to Pfizer Safety.  These requirements are delineated for 3types of events: (1) SAEs; (2) 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
54(88)
non-serious adverse events (AEs); and (3) exposure to the investigational product under study 
during pregnancy or breastfeeding, and occupational exposure. 
Safety Event
Recorded on the CRF
Reported on the CT SAE 
Report Form to Pfizer 
Safety Within 24Hours of 
Awareness
SAE
All
All
Non-serious AE
All
None
Exposure to the 
investigational product 
under study during 
pregnancy or 
breastfeeding, and 
occupational exposure
All (regardlessof whether 
associated with an AE), 
except occupational 
exposure
Exposure during pregnancy, 
exposure via breastfeeding, 
occupational exposure 
(regardless of whether 
associated with an AE)
All observed or volunteered events regardless of suspected causal relationship to the 
investigational product(s) will be reported as described in the following paragraphs.
Events listed in the table above that require reporting to Pfizer Safety on the CT SAE Report 
Form within 24hours of awareness of the event by the investigatorare to be reported 
regardless of whether the event is determined by the investigator to be related to an 
investigational product under study.  In particular, if the SAE is fatal or life-threatening, 
notification to Pfizer Safety must be made immediately, irrespective of the extent of available 
event information.  This time frame also applies to additional new (follow-up) information on 
previously forwarded reports.  In the rare situation that the investigator does not become 
immediately aware of the occurrence of an event, the investigator must report the event within 
24hours after learning of it and document the time of his/her first awareness of the event.
For each event, the investigator must pursue and obtain adequate information both to 
determine the outcome and to assess whether it meets the criteria for classification as an SAE 
(see the Serious Adverse Events section below).  In addition, the investigator may be 
requested by Pfizer Safety to obtain specific follow-up information in an expedited fashion.  
This information is more detailed than that recorded on the CRF.  In general, this will include 
a description of the event in sufficient detail to allow for a complete medical assessment of the 
case and independent determination of possible causality.  Any information relevant to the 
event, such as concomitant medications and illnesses, must be provided.  In the case of a 
subject death, a summary of available autopsy findings must be submitted as soon as possible 
to Pfizer Safety.  Any pertinent additional information must be reported on the CT SAE 
Report Form; additional source documents (eg, medical records, CRF, laboratory data) are to 
be sent to Pfizer Safety ONLYupon request.
As part of ongoing safety reviews conducted by the sponsor, anynon-serious AE that is 
determined by the sponsor to be serious will be reported by the sponsor as an SAE.  To assist 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
55(88)
in the determination of case seriousness, further information may be requested from the 
investigator to provide clarity and understanding of the event in the context of the clinical 
study.
6.1.1.Additional Details On Recording Adverse Events on the CRF
All events detailed in the table above will be recorded on the AE page(s) of the CRF.  It 
should be noted that the CT SAE Report Form for reportingof SAE information is not the 
same as the AE page of the CRF.  When the same data are collected, the forms must be 
completed in a consistent manner.  AEs should be recorded using concise medical 
terminology and the same AE term should be used on both the CRF and the CT SAE Report 
Form for reporting of SAE information.
6.1.2.Eliciting Adverse Event Information
The investigator is to record on the CRF all directly observed AEs and all AEs spontaneously 
reported by the parent(s)/legal guardian/legally acceptable representative.  In addition, each 
parent(s)/legal guardian/legally acceptable representativewill be questioned about the 
occurrence of AEs in a non-leading manner.
6.1.3. Withdrawal From the Study Due to Adverse Events 
Withdrawal due to AEs should be distinguished from withdrawal due to other causes, 
according to the definition of AE noted below, and recorded on the CRF. 
When a subject withdraws from the study because of an SAE, the SAE must be recorded on 
the CRF and reported, as appropriate, on the CT SAE Report Form, in accordance with the 
Requirementssection above.
6.1.4.Time Period for Collecting AE/SAE Information
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each subject begins fromthe time the subject provides informed consent, which is 
obtained before the subject’s participation in the study (ie, before undergoing any 
study-related procedure and/or receiving investigational product), through and including a 
minimum of 28calendar days after the last administration of the investigational product.
For subjects who are screen failures, the active collection period ends when screen failure 
status is determined.
The time period for actively eliciting and collecting AEs and SAEs (“activecollection 
period”) for each subject begins from the time the parent(s)/legal guardian/legally acceptable 
representative provides informed consent, which is obtained before the subject’s participation 
in the study (ie, before undergoing any study-related procedure and/or receiving 
investigational product), through and including SFU Visit. 
6.1.4.1.Reporting SAEs to Pfizer Safety
All SAEs occurring in a subject during the active collection period are reported to Pfizer 
Safety on the CT SAE Report Form.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
56(88)
SAEs occurring in a subject after the active collection period has ended are reported to Pfizer 
Safety if the investigator becomes aware of them; at a minimum, all SAEs that the investigator 
believes have at least a reasonable possibility of being related to investigational product must 
be reported to Pfizer Safety.
Follow up by the investigator continues throughout and after the active collection period and 
until the event or its sequelae resolve or stabilize at a level acceptable to the investigator, and 
Pfizer concurs with that assessment.
6.1.4.2.Recording Non-serious AEs and SAEs on the CRF
During the active collection period, both non-serious AEs and SAEs are recorded on the CRF.
Follow-up by the investigator may be required until the event or its sequelae resolve or 
stabilize at a level acceptable to the investigator, and Pfizer concurs with that assessment.
6.1.5.Causality Assessment
The investigator’s assessment of causality must be provided for all AEs (serious and 
non-serious); the investigator must record the causal relationship on the CRF, and report such 
an assessment in accordance with the SAE reporting requirements, if applicable.  An 
investigator’s causality assessment is the determination of whether there exists a reasonable 
possibility that the investigational product caused or contributed to an AE; generally the facts 
(evidence) or arguments to suggest a causal relationship should be provided.  If the 
investigator does not know whether or not the investigational product caused the event, then 
the event will be handled as “related to investigational product” for reporting purposes, as 
defined by the sponsor.  If the investigator
's causality assessment is “unknown but not related” 
to investigational product, this should be clearly documented on study records. 
In addition, if the investigator determines that an SAE is associated with study procedures, the 
investigator must record this causal relationship in the source documents and CRF, and report 
such an assessment in the dedicated section of the CT SAE Report Form and in accordance 
with the SAE reporting requirements.
6.1.6.Sponsor’s Reporting Requirements to Regulatory Authorities
AE reporting, including suspected unexpected serious adverse reactions, will be carried out in 
accordance with applicable local regulations.
6.2.Definitions
6.2.1.Adverse Events
An AE is any untoward medical occurrence in a study subject administered a product or 
medical device; the event need not necessarily have a causal relationship with the treatment or 
usage.  Examples of AEs include, but are not limitedto: 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
57(88)
Abnormal test findings;
Clinically significant signs and symptoms;
Changes in physical examination findings;
Hypersensitivity;
Progression/worsening of underlying disease;
Drug abuse;
Drug dependency.
Additionally, AEs may include signs and symptoms resulting from:
Drug overdose;
Drug withdrawal;
Drug misuse; 
Drug interactions;
Extravasation;
Exposure during pregnancy (EDP);
Exposure via breastfeeding;
Medication error;
Occupational exposure.
6.2.2.Abnormal Test Findings
Abnormal objective test findings should be recorded as AEs when any of the following 
conditions are met: 
Test result is associated with accompanying symptoms; and/or
Test result requires additional diagnostic testing or medical/surgical intervention; 
and/or
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
58(88)
Test result leads to a change instudy dosing (outside of any protocol-specified 
dose adjustments) or discontinuation from the study, significant additional 
concomitant drug treatment, or other therapy; and/or
Test result is considered to be an AE by the investigator or sponsor.
Merely repeating an abnormal test, in the absence of any of the above conditions, does not 
constitute an AE.  Any abnormal test result that is determined to be an error does not require 
recording as an AE.
6.2.3.Serious Adverse Events
A serious adverse event is any untoward medical occurrence at any dose that:
Results in death;
Is life-threatening (immediate risk of death);
Requires inpatient hospitalization or prolongation of existing hospitalization;
Results in persistent or significant disability/incapacity (substantial disruption of 
the ability to conduct normal life functions);
Results incongenital anomaly/birth defect.
Or that is considered to be:
An important medical event.
Medical and scientific judgment is exercised in determining whether an event is an important 
medical event.  An important medical event may not be immediately life-threatening and/or 
result in death or hospitalization.  However, if it is determined that the event may jeopardize 
the subject or may require intervention to prevent one of the other AE outcomes, the important 
medical event should be reported as serious.
Examples of such events are intensive treatment in an emergency room or at home for allergic 
bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; or 
development of drug dependency or drug abuse.
6.2.4.Hospitalization
Hospitalization is defined as any initial admission (even less than 24hours) in a hospital or 
equivalent healthcare facility, or any prolongation of an existing admission.  Admission also 
includestransfer within the hospital to an acute/intensive care unit (eg, from the psychiatric 
wing to a medical floor, medical floor to a coronary care unit, or neurological floor to a 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
59(88)
tuberculosis unit).  An emergency room visit does not necessarily constitute a hospitalization; 
however, the event leading to the emergency room visit is assessed for medical importance.
Hospitalization does not include the following:
Rehabilitation facilities;
Hospice facilities;
Respite care (eg, caregiver relief);
Skilled nursing facilities;
Nursing homes;
Same-day surgeries (as outpatient/same-day/ambulatory procedures).
Hospitalization or prolongation of hospitalization in the absence of a precipitating clinical AE 
is not in itself an SAE.  Examples include:
Admission for treatment of a preexisting condition not associated with the 
development of a new AE or with a worsening of the preexisting condition (eg, for 
workup of a persistent pretreatment laboratory abnormality);
Social admission (eg, subject has no place to sleep);
Administrative admission (eg, for yearly physical examination);
Protocol-specified admission during a study (eg, for a procedure required by the 
study protocol);
Optional admission not associated with a precipitating clinical AE (eg, for elective 
cosmetic surgery);
Hospitalization for observation without a medical AE;
Preplanned treatments or surgical procedures.  These should be noted in the 
baseline documentation for the entire protocol and/or for the individual subject;
Diagnostic and therapeutic noninvasive and invasive procedures, such as surgery, should not 
be reported as SAEs.  However, the medical condition for which the procedure was performed 
should be reported if it meets the definition of an SAE.  For example, an acute appendicitis 
that begins during the reporting period should be reported if the SAE requirements are met, 
and the resulting appendectomy should be recorded as treatment of the AE.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
60(88)
6.3.Severity Assessment
If required on the AE page of the CRF, the investigator will use the adjectives MILD, 
MODERATE, or SEVERE to describe the maximum intensity of the AE.  For purposes of 
consistency, these intensity grades are defined as follows:
MILD
Does not interfere with subject
's usual function.
MODERATE
Interferes to some extent with subject
's usual function.
SEVERE
Interferes significantly with subject
's usual function.
Note the distinction between the severity and the seriousness of an AE.  A severe event is not 
necessarily an SAE.  For example, a headache may be severe (interferes significantly with the 
subject
's usual function) but would not be classified as serious unless it met one of the criteria 
for SAEs, listed above.
6.4.Special Situations
There are no protocol-specified SAEs in this study.  All SAEs will be reported to Pfizer Safety 
by the investigator as described in previous sections, and will be handled as SAEs in the safety 
database. 
6.4.1.Potential Cases of Drug-Induced Liver Injury
Humans exposed to a drug who show no sign of liver injury (as determined by elevations in 
transaminases) are termed“tolerators,” while those who show transient liver injury, but adapt 
are termed “adaptors.”  In some subjects, transaminase elevations are a harbinger of a more 
serious potential outcome.  These subjects fail to adapt and therefore are "susceptible" to 
progressive and serious liver injury, commonly referred to as drug-induced liver injury (DILI).  
Subjects who experience a transaminase elevation above 3times the upper limit of normal (×
ULN) should be monitored more frequently to determine if they are an “adaptor” or are 
“susceptible.”
In the majority of DILI cases, elevations in aspartate aminotransferase (AST) and/or alanine 
aminotransferase (ALT) precede total bilirubin (TBili) elevations (>2×ULN) by several days 
or weeks.  The increase in TBili typically occurs while AST/ALT is/are still elevated above 
3×ULN (ie, AST/ALT and TBili values will be elevated within the same lab sample).  In rare 
instances, by the time TBili elevations are detected, AST/ALT values might have decreased.  
This occurrence is still regarded as a potential DILI.  Therefore, abnormal elevations in either 
AST OR ALT in addition to TBili that meet the criteria outlined below are considered 
potential DILI (assessed per Hy’s law criteria) casesand should always be considered 
important medical events, even before all other possible causes of liver injury have been 
excluded.
The threshold of laboratory abnormalities for a potential DILI case depends on the subject’s 
individual baseline values and underlying conditions.  Subjects who present with the 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
61(88)
following laboratory abnormalities should be evaluated further as potential DILI (Hy’s law) 
cases to definitively determine the etiology of the abnormal laboratory values:
Subjects with AST/ALT and TBilibaseline values within the normal range who 
subsequently present with AST OR ALT values >3×ULN AND a TBili value 
>2×ULN with no evidence of hemolysis and an alkaline phosphatase value <2×ULN 
or not available;
For subjects with baseline AST OR ALT ORTBili values above the ULN, the 
following threshold values are used in the definition mentioned above, as needed, 
depending on which values are above the ULN at baseline:
Preexisting AST or ALT baseline values above the normal range:AST or ALT 
values >2times the baseline values AND >3×ULN; or >8×ULN (whichever is 
smaller).
Preexisting values of TBili above the normal range: TBili level increased from 
baseline value by an amount of at least 1× ULN orif the value reaches >3× ULN 
(whichever is smaller).
Rises in AST/ALT and TBili separated by more than a few weeks should be assessed 
individually based on clinical judgment; any case where uncertainty remains as to whether it 
represents a potential Hy’s law case should be reviewed with the sponsor. 
The subject should return to the investigator site and be evaluated as soon as possible, 
preferably within 48hours from awareness of the abnormal results.  This evaluation should 
include laboratory tests, detailed history, and physical assessment. 
In addition to repeating measurements of AST and ALT and TBili, laboratory tests should 
include albumin, creatine kinase (CK), direct and indirect bilirubin, gamma-glutamyl 
transferase (GGT), prothrombin time (PT)/international normalized ratio (INR), total bile 
acids, alkaline phosphatase and acetaminophen drug and/or protein adduct levels.  
Consideration should also be given to drawing a separate tube of clotted blood and an 
anticoagulated tube of blood for further testing, as needed, for further contemporaneous 
analyses at the time of the recognized initial abnormalities to determine etiology.  A detailed 
history, including relevant information, such as review of ethanol, acetaminophen (either by 
itself or as a coformulated product in prescription or over-the-counter medications), 
recreational drug,supplement (herbal) use and consumption, family history, travel history, 
history of contact with a jaundiced person, surgery, blood transfusion, history of liver or 
allergic disease, and potential occupational exposure to chemicals, should be collected.  
Further testing for acute hepatitis A, B, C, D, and E infection and liver imaging (eg, biliary 
tract) may be warranted. 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
62(88)
All cases demonstrated on repeat testing as meeting the laboratory criteria of AST/ALT and 
TBili elevation defined above should be considered potential DILI (Hy’s law) cases if no 
other reason for the LFT abnormalities has yet been found.  Such potential DILI (Hy’s law) 
cases are to be reported as SAEs, irrespective of availability of all the results of the 
investigations performed to determine etiology of the LFT abnormalities.
A potential DILI (Hy’s law) case becomes a confirmed case only after all results of reasonable 
investigations have been received and have excluded an alternative etiology.
6.4.2.Exposure to the Investigational Product During Pregnancy or Breastfeeding, and 
Occupational Exposure
Occupational exposure to the investigational product under study isreportable to Pfizer Safety 
within 24hours of investigator awareness.
6.4.2.1.Exposure During Pregnancy
Not applicable.  
6.4.2.2.Exposure During Breastfeeding
Not applicable.  
6.4.2.3.Occupational Exposure
An occupational exposure occurs when, during the performance of job duties, a person 
(whether a healthcare professional or otherwise) gets in unplanned direct contact with the 
product, which may or may not lead to the occurrence of an AE.
An occupational exposure is reported to Pfizer Safety within 24hours of the investigator’s 
awareness, using the CT SAE Report Form, regardless of whether there is an associated SAE.  
Since the information does not pertain to a subject enrolled in the study, the information is not 
recorded on a CRF; however, a copy of the completed CT SAE Report Form is maintained in 
the investigator site file.
6.4.3. Medication Errors and Lack of Efficacy
Other exposures to the investigational product under study may occur in clinical trial settings, 
such as medication errors and lack of efficacy.
Safety Event
Recorded on the CRF
Reported on the CT SAE 
Report Form to Pfizer 
Safety Within 24Hours of 
Awareness
Medication errorsand lack of 
efficacy
All (regardless of whether 
associated with an AE)
Only if associated with an 
SAE
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
63(88)
6.4.3.1.Medication Errors
Medication errors may result from the administration or consumption of the investigational 
product by the wrong subject, or at the wrong time, or atthe wrong dosage strength, or at the 
wrong infusion rate. 
Medication errors include:
Medication errors involving subject exposure to the investigational product;
Potential medication errors or uses outside of what is foreseen in the protocol that do 
or do not involve the participating subject.
Such medication errors occurring to a study participant are to be capturedon the CRFper 
CRF completion guidelines.
In the event of a medication dosing error, the sponsor should be notified immediately.
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the CRF per CRF completion guidelines and, 
if applicable, any associated AE(s), serious and non-serious, are recorded on an AE page of 
the CRF.
Medication errors should be reported to Pfizer Safety within 24hours on a CT SAE Report 
Form only when associated with an SAE.
6.4.3.2.Lack of Efficacy 
Lack of efficacy is reportable to Pfizer Safety only if associated with an SAE.
6.5.Study governance and oversight
The safety of all Pfizerclinical studies is closely monitored on an on-going basis by Pfizer and 
itsrepresentatives.  Issues identified will be addressed; for instance this could involve 
amendments to the study protocol and letters to Investigators.
6.5.1.Data and Safety Monitoring Board
An external DSMB meeting is to be held at regular intervals to evaluate the safety of this 
study and other ongoing pediatricstudies of ceftaroline fosamil.  The role of the DSMB 
members is to evaluate the safety ofthe pediatricstudies on an ongoing basis in order to 
determine whether any undue safety concerns are observed, and thus whether the studies 
should be allowed to continue enrolment.  The recommendations made by the DSMBto alter 
the conduct of the study will be forwarded to the Sponsor for final decision.  The Sponsorwill 
forward such decisions, which may include summaries of aggregate analyses of endpoint 
events and of safety data that are not endpoints, to regulatory authorities, as appropriate.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
64(88)
A detailed DSMB charter will be prepared by the Sponsor and agreed to by all DSMB 
members before initiation of enrolment in this study.  This charter will document the timing, 
membership, analysis content, and review procedures for each DSMB meeting.  Safety 
information will be prepared in advance of each DSMB meeting by an independent reporting 
statistician.  Safety analyses will include, at a minimum, summaries of study disposition and 
all AEs, SAEs, deaths, and discontinuations due to AEs, potentially clinically significant 
(PCS) laboratory results, and individual patient listings of selected safety data.
7.INVESTIGATIONAL PRODUCT AND OTHER TREATMENTS
For the purposes of this study, and per International Conference on Harmonisation (ICH) 
guidelines, investigational product is defined as a pharmaceutical form of an active ingredient 
or placebo being tested or used as a reference/comparator in a clinical trial, including a 
product with a marketing authorization when used or assembled (formulated or packaged) in a 
waydifferent from the approved form, or when used for an unapproved indication, or when 
used to gain further information about an approved use (ICH E61.33). 
For this study, the investigational product is ceftaroline fosamil.
7.1.Identity of investigational product(s)
Investigational product
Dosage form and strength
Ceftaroline fosamil
600mg powder for concentrate for solution for infusion
7.1.1.Ceftaroline Fosamil
Ceftaroline fosamil for injection, 600mg per vial, is supplied as a sterile pale yellowish-white 
tolight yellow crystalline powder in a single-dose, clear glass 20mL vial.  The excipient 
L-arginine is added as an alkalizing agent to maintain the constituted solution between pH 
4.8and 6.5.
7.1.1.1.Directions for Use
Vials of ceftaroline fosamil are constituted with 20.0mL of sterile water for injection; the 
amount of solution containing the appropriate dose is further diluted in sterile normal saline 
before infusion.  Refer to the Investigational Product Handling Manual for detailed 
information on ceftarolinefosamil preparation.
7.1.1.2.Drug Storage
Vials containing unreconstituted ceftaroline fosamil are stored according to labelled 
requirements.  Constituted and diluted infusion bags or bottles should be stored and used per 
the directions presented in the Investigational Product Handling Manual.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
65(88)
7.1.2.Ampicillin and Optional Aminoglycoside
Ampicillin (if mandated as per Section 7.2.2) is to be initiated at Baseline and to be 
administered for at least 48hours(minimum duration of study therapy); after 48hours, the 
duration of treatment with ampicillin is at the discretion of the investigator.
The use of an aminoglycoside is considered optional from Baseline through the entire study, 
ie, may be started and stopped at any time during the study at the discretion of the 
investigator.
Consult the product package insert, label, and local dosing guidelines for further information 
regarding dosage, administration, storage, maximum doses, contraindications, warnings, 
precautions, and AEs reported. 
7.2.Dose and treatment regimens
Patients will receive a combination of IV ceftaroline fosamil and ampicillin, plus an optional 
aminoglycoside of choice as an empiric therapy for LOS.  The total duration of study therapy 
is 48hours (minimum) to 14days (maximum).  Note that study therapy administration using a 
home health care service is not permitted.
7.2.1.Ceftaroline fosamil
Ceftaroline fosamil is approved for use in adults; thus, treatment with ceftaroline fosamil is 
limited in pediatricpatients to investigational use only.  In this study, each patient will receive 
ceftaroline fosamil 6mg/kg IV over 60(± 10) minutes q8h (±1hour).
7.2.2.Ampicillin
Ampicillin (if mandated, see below) is to be initiated at Baseline and to be administeredfor at 
least 48hours (minimum duration of study therapy); after 48hours, the duration of treatment 
with ampicillin is at the discretion of the investigator. 
If the presence of an organism that requires treatment with ampicillin cannot be excluded, then
the use of IV ampicillin for the first 48hours is mandatory.  If the resultsof additional 
microbiology, PCR or other investigations indicate that ampicillin during the first 48hours of 
treatment is not required, then its use is at the discretion of theinvestigator (note: the findings 
of any such investigations must be fully documented in the patient’s source data).
7.2.3.Aminoglycoside
The use of an aminoglycoside is considered optional from Baseline through the entire study, 
ie, aminoglycoside may be started and stopped at any time during the study at the discretion of 
the investigator.  Gentamicin is preferred.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
66(88)
7.2.4.Dose adjustment
Patients with moderately or severely impaired renal function at screening, defined as serum 
creatinine ≥2× ULN for age, urine output <0.5mL/kg/h (calculated from an 8-hour urine 
collection; for hospitalized patients), or requirement for dialysis, will not be enrolled in this 
study; thus, no ceftaroline fosamil, ampicillin, or aminoglycoside dose adjustments are 
expected to be required for renal impairment.
Ampicillin and/or aminoglycoside dose adjustments needed per the investigator’s judgment 
should be made per institutional guidelines.
However, if the patient’s serum creatinine level increases ≥2× ULN or the urine output 
decreases to <0.5mL/kg/h (calculated from an 8-hour urine collection), the Medical Monitor 
should be contacted with the option to miss or postpone dosing, or discontinue the study.
7.3.Labelling
Labels will be prepared in accordance with Good Manufacturing Practice (GMP) and local 
regulatory guidelines.  The labels will fulfil GMP Annex 13requirements for labelling.  Label 
text will be translated into local language.
7.4.Storage
All study drugs should be kept in a secure place with controlled access under appropriate 
storage conditionsand in accordance with applicable regulatory requirements.  The IP label 
specifies the appropriate storage.
Site systems must be capable of measuring and documenting (for example, via a log), at a 
minimum, daily minimum and maximum temperatures for all site storage locations.  This 
should be captured from the time of investigational product receipt throughout the study.  
Even for continuous-monitoring systems, a log or site procedure that ensures active evaluation 
for excursions should be available.  The intent is to ensure that the minimum and maximum 
temperature is checked each business day to confirm that no excursion occurred since the last 
evaluation and to provide the site with the capability to store or view the minimum/maximum 
temperature for all non-working days upon return to normal operations.  The operation of the 
temperature monitoring device and storage unit (for example, refrigerator), as applicable, 
should be regularly inspected to ensure they are maintained in working order. 
Any excursions from the product label storage conditions should be reported to Pfizer upon 
discovery.  The site should actively pursue options for returning theproduct to the storage 
conditions described in the labeling, as soon as possible.  Deviations from the storage 
requirements, including any actions taken, must be documented and reported to Pfizer. 
Once an excursion is identified, the investigational product must be quarantined and not used 
until Pfizerprovides permission to use the investigational product.  It will not be considered a 
protocol deviation if Pfizer approves the use of the investigational product after the 
temperature excursion.  Use of theinvestigational product prior to Pfizer approval will be 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
67(88)
considered a protocol deviation.  Specific details regarding information the site should report 
for each excursion will be provided to the site.
7.5.Compliance
All treatments will be administered by hospital staff during hospitalization.  Treatment 
compliance will be documented by study staff in the CRF by recording the infusion date, time, 
and volume.
7.6.Accountability
The investigator site must maintain adequate records documenting the receipt, use, loss,or 
other disposition of the investigational product supplies.  It is the responsibility of the 
Pharmacist or designee to ensure that current records of study drug inventory and 
accountability are maintained.  Records must be readily available for inspection by the 
Sponsor or Sponsor’s Representative and applicable regulatory authorities.
Upon receipt of study therapy drugs, the Pharmacist or designee will acknowledge receipt, 
visually inspect the shipment, verify the number of vials shipped are received, and document 
the condition of the drugs received.  Refer to the Investigational ProductHandling Manual for 
additional information.
7.6.1.Study drug handling and disposal
For general drug destruction (eg, left over drug at site), the investigator must ensure thatthe 
materials are destroyed in compliance with applicable environmental regulations, institutional 
policy, and any specialinstructions provided by the Sponsor, and all destruction must be 
adequately documented.  Where at all possible the IP should be destroyed locally at site and a 
third party supplier for return and destruction should only be used where specific country 
regulations or local procedures state this is not possible.  Documentation should be provided 
by PRA or the Sponsoridentifying that this is the case.  For investigational product associated 
with a recall, the Sponsorwill determine what is to be destroyed.  The Sponsor or its 
representativewill manage the execution of destruction using standards acceptable to the 
Sponsoror its representative.
7.7.Concomitant and other treatments 
All prior medications (taken or received within 7days before the first dose of study therapy) 
and all concomitant medications (taken during the study), including,but not limited to, all 
antimicrobials, parenteral nutrition, and blood and blood-component transfusions will be 
documented.  For patients who are being breast fed, all medications taken by the lactating 
mother for 3days before first dose of study therapy through SFU will also be recorded.
Concomitant antibacterial therapy is not permitted except in the case of clinical failure.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
68(88)
7.7.1.Other concomitant treatment
Other medication other than that described above, which is considered necessary for the 
patient’s safety and wellbeing, may be given at the discretion of the investigator and recorded 
in the appropriate sections of the CRF.
8.STATISTICAL ANALYSES
8.1.Statistical considerations
A comprehensive Statistical Analysis Plan (SAP) will be prepared and finalized before 
database lock and analysis of the data.
8.2.Sample size estimate
The primary objective of this study is to evaluate safety and tolerability of ceftaroline in 
neonates and young infants aged 7to <60days with LOS and the study is not powered for 
inferential statistical analysis.  The sample size (24patients; 3cohorts of 8patients) is 
considered adequate to evaluate the safety of ceftaroline in neonates and young infants with 
LOS.
8.3.Definitions of analysis sets
Analysis sets are described below and in Figure 2.
8.3.1.Intent-to-treat analysis set
The Intent-to-Treat (ITT) Analysis Set will consist of all enrolled patients.
8.3.2.Safety analysis set
The Safety Analysis Set will be a subset of the ITT Analysis Set and will include all patients 
who receive any amount of ceftaroline fosamil.
8.3.3.Modified intent-to-treat (MITT) analysis set
The MITT Analysis Set will include all patients who receive any amount of ceftaroline 
fosamil and who meet minimal disease criteria of LOS as described in the inclusion criteria in 
Section 3.1(diagnosis of sepsis within 36hours before enrolment, defined as the presence of 
at least 2clinical criteria and at least 1laboratory criterion in the presence of or as a result of 
suspected or proven bacterial infection that requires IV antibiotic therapy).  Patients with 
confirmed infection with a pathogen known to be resistant to the study therapy received and 
patients with a confirmed fungal, parasitic, or viral pathogen as the sole cause of infection will 
be excluded.  A list of resistant pathogens will be provided in the SAP.
8.3.4.Pharmacokinetic (PK) analysis set
The PK Analysis Set will include all patients who receive a known amount of ceftaroline 
fosamil and who have had at least 1PK sample collected (excluding those receiving blood or 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
69(88)
blood component transfusions within 24hours before sample collection or who are at risk 
from additional blood loss per the discretion of the investigator).
Figure 2 Study Analysis Sets
8.4.Outcome measures for analyses
8.4.1.Efficacy response definitions
8.4.1.1.Clinical outcome at End-of-Therapy
An assessment of clinical outcome will be made by the investigator at EOT.  The clinical 
outcome categories are defined in Table 4.  A favourable clinical outcome is clinical cure.  An 
outcome of clinical failure at EOT will be carried forward to TOC.
Intent-to-Treat (ITT)
All subjects
Safety
Received any amount of ceftaroline fosamil
Modified Intent-to-Treat (MITT)
Meet minimal disease criteria of LOS(excluding 
subjects with confirmed infection with a resistant 
pathogen known to be resistant to study therapy 
received; or confirmed fungal, parasitic, or viral 
pathogen as the sole cause of the infection)
Pharmacokinetic (PK)
Received a known amount of 
ceftaroline fosamil and has ≥1 PK 
sample
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
70(88)
Table 4
Clinical outcome categories at End-of-Therapy
Outcome
Definition
Clinical Cure
Resolution of allacute signs and symptoms of LOS or improvement to such 
an extent that no further antibacterial therapy is required
Clinical Failure
Patients who received ≥48hours of study treatment and meet any of the 
following:
Discontinuation of study therapy due to insufficient therapeutic 
effect, including persistence, incomplete clinical resolution, 
worsening in signs and symptoms of LOS, or isolation of a resistant 
pathogen that requires alternative nonstudy antibacterial therapy
Discontinuation of study therapy due to a study therapy-related AE 
and requirement for alternative nonstudy antibacterial therapy for 
LOS
Death in which LOS is contributory
Indeterminate
Study data are not available for evaluation of efficacy for any reason, 
including:
Death in which LOS is clearly noncontributory
Lost to follow-up
Extenuating circumstances precluding classification as a cure or 
failure
Diagnosis of CNS infection, osteomyelitis, endocarditis, or NEC at 
any time after enrolment
Received <48hours of study therapy
Abbreviations: AE=adverse event; CNS=central nervous system; LOS=late-onset sepsis; NEC=necrotizing 
enterocolitis.
8.4.1.2.Clinical outcome at Test-of-Cure
An assessment of clinical outcome will be made by the investigator at TOC.  The clinical 
outcome categories are defined in Table 5.  A favourable clinical outcome is clinical cure.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
71(88)
Table 5
Clinical outcome categories at Test-of-Cure
Outcome
Definition
Clinical Cure
Resolution of all acute signs and symptoms of LOS or improvement to such 
an extent that no further antibacterial therapy is required
Clinical Failure
Patients who received ≥48hours of study treatment and meet either of the 
following criteria:
Incomplete resolution or worsening of LOS signs or symptoms or 
development of new signs or symptoms, or isolation of a resistant 
pathogen requiring alternative nonstudy antibacterial therapy
Death in which LOS is contributory
Indeterminate
Study data are not available for evaluation of efficacy for any reason, 
including:
Death in which LOS is clearly noncontributory
Lost to follow-up
Extenuating circumstances precluding classification as a cure or 
failure
Diagnosis of CNS infection, osteomyelitis, endocarditis, or NEC at 
any time after enrolment
Received <48hours of study therapy
Abbreviations: CNS=central nervous system; LOS=late-onset sepsis; NEC=necrotizing enterocolitis.
8.4.2.Microbiological response definitions
8.4.2.1.Microbiological Outcome at Test-of-Cure
The per-pathogen microbiological outcome categories at EOT and TOC are defined in Table 
6.  Favourable microbiological outcomes are eradication orpresumed eradication.  Per-patient 
microbiological response at EOT and TOC will be determined programmatically based on 
individual outcomes for each baseline pathogen.  In order for a patient to have a favourable 
microbiological response, the outcome for each baseline pathogen must be favourable 
(eradicated or presumed eradicated).  If the outcome for any pathogen is unfavourable 
(persistence or presumed persistence), the patient will be considered to have an unfavourable 
microbiological response.
Baselinepathogens will be determined based on central laboratory data.  Rules for 
determination of pathogens will be described in the SAP.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
72(88)
Table 6
Per-pathogen microbiological outcomes categories at End of Treatmentand
Test-of-Cure
Microbiological Responsea
Definition
Eradication
Source specimen demonstrated absence of the original 
baseline pathogen
Presumed eradication
Source specimen was not available to culture and the patient
was assessed as a clinical cure
Persistence
Source specimen demonstrates continued presence of the 
original baseline pathogen
Presumed persistence
Source specimen was not available to culture and the patient
was assessed as a clinical failure
Indeterminate
Source specimen was not available to culture and the 
patient’s clinical outcome was assessed as indeterminate
a
For patients who are clinical failures before TOC, the microbiological outcome will be carried forward to 
TOC and will be determined based on the cultures and/or clinical outcome at the time of the early clinical failure 
determination.
8.5. Methods for statistical analyses
Descriptive statistics (number, mean, SD, median, minimum, and maximum) will be provided 
for continuous variables, and frequency distributions (counts and percentages) will be shown 
for categorical variables.  All variables will be summarized overall and by age cohort.  
Listings of individual patients’ data will also be produced.
8.5.1.Analysis of the study population and patientcharacteristics
Patient disposition (enrolment, discontinuations from the study) overall and within each age 
cohort will be provided based on the ITT Analysis Set.  Reasons for exclusion from study 
analysis sets will be summarized for the ITT Analysis Set.
Demographics (age, race, gender), medical and surgical history including 
antepartum/peripartum period, baseline assessment of the clinical signs and symptoms of 
LOS, microbiological assessment of blood, CSF, urine, and other specimens or tissue samples 
will also be summarized for the ITT Analysis Set.
8.5.2.Analysis of the primary variable
The safety analysis will be performed using the Safety Analysis Set and will include all 
patients who receive any amount of study therapy.  Safety parameters include AEs, SAEs, 
deaths, clinical laboratory parameters (eg, CBC with differential, chemistry panel), and vital 
signs.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
73(88)
For each safety parameter, the last assessment made before the first dose of study therapy will 
be used as the baseline for all analyses.  In the case of ECG where data are collected in 
triplicate, the mean of thethree recordings will be considered as the baseline.
The incidence of AEs, SAEs, deaths, and discontinuations due to AEs will be summarized 
overall and within each age cohort, by system organ class and preferred term according to the 
Medical Dictionary for Regulatory Activities (MedDRA), by relationship to the study therapy, 
and by severity.
Descriptive statistics of observed results and the change from baseline will be presented for 
clinical laboratory results and vital signs.  The incidence of selected PCS laboratory results 
will be summarized.  A list of PCS results will be provided in the SAP.
8.5.3.Analysis of the secondary variables
Efficacy response will be analysed using the MITT Analysis Set.  Proportions of patients with 
a favourable efficacy response will be displayed overall and within each age cohort.  The 
number and percentage of patients classified as clinical cure at EOT and TOC will be 
tabulated in the MITT Analysis Set.
Microbiological success at EOT and TOCS will be evaluated.  A summary of microbiological 
outcome by patient and by pathogen will be presented.
Every effort will be made to collect all data at specified times.  A detailed description of the 
handling of dropouts and missing data for all efficacy and safety evaluations will be provided 
in the SAP.
8.5.3.1.Pharmacokinetic sample collection and analyses
The PK data acquisition and analysis strategy in this study entails the use of a sparse PK 
sampling schedule, conducted only at selected investigational centres.  Centres will be 
selected based on location, ability to conduct PK sampling procedures with accuracy, and 
ability to store and ship PK samples appropriately.
Pharmacokinetic sample handling and shipping procedures are described in the PK Sample 
Handling and Shipping Manual.
Concentrationsof ceftaroline and ceftaroline M-1in CSF will be presented.
Plasma concentrations of ceftaroline fosamil, ceftaroline and ceftaroline M-1will be listed by 
age cohort.  Ceftaroline plasma concentration data, along with other information including 
demographic data, will be combined with appropriate data from other clinical studies and 
analysed using a population PK approach and reported separately. 
8.6.Interim Analysis
No formal interim analysis will be conducted for this study.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
74(88)
9.STUDY AND DATA MANAGEMENT 
9.1.Training of study site personnel
A Co-ordinating Investigator will be selected from the investigators who will conduct the 
study (per European Union directive 75/318/EEC [as amended] Annex Part 4C).
Each investigator must adhere to the protocol as detailed inthis document and agree that the 
Sponsor must approve any change to the protocol before seeking approval from the 
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) or Competent 
Authority (CA).  Each investigator will be responsible for enrolling only those patients who 
have met all of the protocol inclusion criteria and none of the exclusion criteria.
Before the first patient is entered into the study, aSponsorrepresentative will review and 
discuss the requirements of the Clinical StudyProtocol and related documents with the 
investigational staff and also train them in any study specific procedures and the PRA Data 
Labs Electronic Data Capture (EDC) system utilized.
The PI will ensure that appropriate training relevant to the study is given to all of these staff, 
and that any new information relevant to the performance of this study is forwarded to the 
staff involved.
The PI will maintain a record of all individuals involved in the study (medical, nursing and 
other staff).
9.2.Monitoring of the study
During the study, the Sponsorrepresentative will have regular contacts with the study site, 
conducted in accordance with current ICH E6Good Clinical Practice (GCP) guidelines, and 
the respective United States or foreign regulations and guidelines, as applicable.  Contacts will 
include visits to:
Provide information and support to the investigator(s)
Confirm that facilities remain acceptable
Confirm that the investigational team is adhering to the protocol, that data are being 
accurately and timely recorded in the CRFs, that biological samples are handled in 
accordance with the Laboratory Manual and that study drug accountability checks are 
being performed
Perform source data verification (a comparison of the data in the CRFs with the 
patient’s medical records at the hospital or practice, and other records relevant to the 
study) including verification of informed consent of participating patients.  This will 
require direct access to all original records for each patient (eg, clinic charts)  
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
75(88)
Ensurewithdrawal of informed consent to the use of the patient’s biological samples is 
reported and biological samples are identified and disposed of/destroyed accordingly, 
and the action is documented, and reported to the patient.
The Sponsorrepresentative will also be able to review query status remotely, which may 
warrant additional communication with the investigator and the study centre
's personnel.  The 
investigator will make available to the Sponsorrepresentative source documents, signed ICFs, 
and all other study related documents.  The Sponsorrepresentative will be available between 
visits if the investigator(s) or other staff at the centre needs information and advice about the 
study conduct
9.2.1.Source data
Refer to the CSA for location of source data.
Source documents may include, but are not limited to, study progress notes, study-or 
patient-specific e-mail correspondence, computer printouts, laboratory data, and recorded data 
from automated instruments.  In most cases, the source documents are the hospital or the 
physician subject chart.  In these cases, data collected on the CRFs must match the data in 
those charts. 
In some cases, the CRF may also serve as the source document.  In these cases, a document 
should be available at the investigator site and atthe Sponsorthat clearly identifies those data 
that will be recorded on the CRF, and for which the CRF will stand as the source document.
The original signed ICF for each participating patient shall be filed with records kept by the 
investigator.  Alldocuments produced in this study will be maintained by the investigator and 
made available for inspection by the Sponsor or Sponsor representative and applicable 
regulatory authorities.
9.2.2.Study agreements
The PI at each/the centre should comply with all theterms, conditions, and obligations of the 
CSA, or equivalent, for this study.  In the event of any inconsistency between this Clinical 
Study Protocol and the CSA, the terms of Clinical Study Protocol shall prevail with respect to 
the conduct of the study and the treatment of patients and in all other respects, not relating to 
study conduct or treatment of patients, the terms of the CSA shall prevail.
Agreements between the Sponsorand the Principal Investigator should be in place before any 
study-related procedures can take place, or patients are enrolled.
9.2.3.Archiving of study documents
The investigator follows the principles outlined in the CSA.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
76(88)
To enable evaluations and/or inspections/audits from regulatory authorities or Pfizer, the 
investigator agrees to keep records, including the identity of all participating subjects 
(sufficient information to link records, eg, CRFs and hospital records), all original signed 
informed consentdocuments, copies of all CRFs, safety reporting forms, source documents, 
and detailed records of treatment disposition, and adequate documentation of relevant 
correspondence (eg, letters, meeting minutes, and telephone call reports).  The records should 
be retained by the investigator according to the ICH guidelines, according to local regulations, 
or as specified in the clinical study agreement (CSA), whichever is longer.
If the investigator becomes unable for any reason to continue to retain study records for the 
required period (eg, retirement, relocation), Pfizer should be prospectively notified.  The study 
records must be transferred to a designee acceptable to Pfizer, such as another investigator, 
another institution, or an independent third party arranged by Pfizer. 
Investigator records must be kept for a minimum of 15years after completion or 
discontinuation of the study or for longer if required by applicable local regulations. 
The investigator must obtain Pfizer
's written permission before disposing of any records, even 
if retention requirements have been met.
9.2.3.1.Data handlingand record keeping
Training sessions; monitoring of the investigative centre by the Sponsor or Sponsor 
representative; instruction manuals; and data verification, crosschecking, and auditing will be 
provided or performed to ensure quality of all study data.  One or more investigator meetings 
will be held to prepare the investigator and other study personnel for appropriate collection of 
study data.
A CRF is required and should be completed for each included subject.  The completed 
original CRFs are the sole property of Pfizer and should not be made available in any form to 
third parties, except for authorized representatives of Pfizer or appropriate regulatory 
authorities, without written permission from Pfizer.
The investigator has ultimate responsibility for the collection and reporting of all clinical, 
safety, and laboratory data entered on the CRFs and any other data collection forms (source 
documents) and ensuring that they are accurate, authentic/original, attributable, complete, 
consistent, legible, timely (contemporaneous), enduring, and available when required.  The 
CRFs must be signed by the investigator or by an authorized staff member to attest that the 
data contained on the CRFs are true.  Any corrections to entries made in the source documents 
must be dated, initialed, and explained (if necessary) and should not obscure the original 
entry. 
The Sponsor or Sponsor representative will review and validate study data as defined in the 
monitoring plan.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
77(88)
The Sponsorwill provide the PI with a file in which to organize and retain all study-related 
documents.  All study documents (including letters from the Sponsor or its representatives) 
should be retained in this file by the PI.  The monitor will regularly check the file to ensure 
that all relevant documents are retained.  The contents of the file may be audited/inspected by 
the Sponsor’s auditor, regulatory authorities, or IRB.
It will be the responsibility of the investigator to ensure that the essential documents are 
available in the investigator’s files or at the institutional centre.  Any or all of these documents 
should be available for monitoring by the Sponsor or Sponsor representative and inspection by 
the regulatory authorities as defined in the monitoring plan.
9.3.Study timetable and end of study
The end of the study in all participating countries is defined as ‘the last visit of the last patient 
undergoing the study’or date of study closure in the case of early study termination, 
whichever date is later.
9.3.1.Study completion
The Sponsor requires the following data and materials before a study can be considered 
complete or terminated, including, but not limited to:
Laboratory findings, clinical data, and all special test results from screening through 
SFU
CRFs properly completed by appropriate study personnel and signed and dated by the 
investigator within the EDC system.  This approval method will include applying an 
electronic signature, a uniquely assigned user name, and a password that together will 
represent a traditional handwritten signature.
Copies of complete study drug accountability records (eg, study drug inventory logs 
and shipment and return records)
Copies of all IRB/IEC or CA approvals and acknowledgements
A summary of the study prepared by the investigator (an IRB/IEC or CA summary 
letteris acceptable)
9.3.2.Guidance to investigators on when to end study therapy
Patients who are improving clinically will receive at least 48hours, but no more than 14days, 
of study therapy.  Before ending study therapy, patients should demonstrate improvement in 
the clinical assessment of their infection from Baseline as follows:
Resolution of all acute signs and symptoms of LOS or improvement to such an extent 
that no further antibacterial therapy is necessary
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
78(88)
Microbiological eradication (confirmed or presumed).
An assessment of clinical outcome will be made by the investigator at the end of study therapy 
as defined in Section 4.2.5.
If signs and symptoms have not resolved or improvedafter 14days,refer to Section 3.9.1.
9.3.3.Study termination by Sponsor and termination criteria
The Sponsor reserves the right to terminate an investigational site or this study at any time.  
Reasons for termination may include, but are not limited to, the following:
The incidence or severity of AEs in this or other studies of ceftaroline indicates a 
potential health hazard to patients
Serious or persistent noncompliance by the investigator with the protocol, clinical 
research agreement, Form FDA 1572, or applicable regulatory guidelines in 
conducting the study
IRB/IEC or CA decision to terminate or suspend approval for the investigation or the 
investigator
Investigator request to withdraw from participation
Patient enrolment is unsatisfactory.
Regulatory authority decision to terminate study
Sponsor discontinues development of ceftaroline
If a study is prematurely terminated, Pfizer will promptly notify the investigator.  After 
notification, the investigator must contact all participating subjects and the hospital pharmacy 
(if applicable) within a reasonable timeframe (ie, two weeks).  As directed by Pfizer, all study 
materials must be collected and all CRFs completed to the greatest extent possible.
9.4.Data management 
Data management will be performed by PRA according to the Clinical Informatics Plan.  
Adverse events and medical/surgical history will be classified according to the terminology of 
the latest version of the MedDRA.  Medications will be classified according to the Sponsor
Drug Dictionary.  Classification coding will be performed by the PRA Coding Group.
Data collection will involve the use of the PRA Data Labs EDC system, to which only 
authorized personnel will have access.  Electronic CRFs will be usedto capture study data in 
an EDC system.  Entering of CRFs should be handled in accordance with instructions from 
the Sponsor or Sponsor representative.  All CRFs must be completed by qualified study centre 
personnel.  Each investigator is responsible for ensuring that accurate data are entered into the 
EDC system in a timely manner.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
79(88)
Before the first patient is dosed at the investigational site, the Sponsor or Sponsor 
representative will meet with the investigator and the study centre
's personnel to train them on 
recording the data on the CRFs using the EDC system.  The investigator or designee will be 
responsible for reviewing CRFs, resolving data queries generated by the Sponsor via the 
system, providing missing or corrected data, approving all changes performed on the patient 
data, and endorsing these data within the EDC system.  This approval method will include 
applying an electronic signature, a uniquely assigned user name, and a password that together 
will represent a traditional handwritten signature.
The data collected through third party sources will be obtained and reconciled against study 
data.
Adverse events and medical/surgical history will be classified according to the terminology of 
the latest version of MedDRA.  Medications will be classifiedaccording to the SponsorDrug 
Dictionary.  All coding will be performed by the PRA Coding Group.
Data queries will be raised for inconsistent, impossible or missing data.  All entries to the 
study database will be available in an audit trail.  Queries maybe issued electronically to the 
clinical study centre and answered electronically by that study centre
's personnel.  The 
identifying information (assigned user name, date, and time) for both the originator of the 
query and the originator of the data change (if applicable) will be collected.
The data will be validated as defined in the Clinical Informatics Plan and Edit Specifications 
Document.  Quality control procedures will be applied to each stage of data handling to ensure 
that all data are reliable and have been processed correctly.  The Clinical Informatics Plan will 
also clarify the roles and responsibilities of the various functions and personnel involved in 
the data management process.
When all data have been coded, validated, signed and locked, clean file will be declared.  Any 
treatment revealing data may thereafter be added and the final database will be locked.
All data collected in the context of this study will be stored and evaluated per regulatory 
requirements and applicable guidance for electronic records.
Serious Adverse Event (SAE) Reconciliation
SAE reconciliation between safety data and clinical data will be performed by PRA.  The 
frequency depends on the expected volume of SAE reports and will be defined in the AE/SAE 
Reconciliation Plan.
10.ETHICAL AND REGULATORY REQUIREMENTS
10.1.Ethical conduct of the study
The study will be conductedin accordance with the protocol, legal and regulatory 
requirements, and the general principles set forth in the International Ethical Guidelines for 
Biomedical Research Involving Human Subjects (Council for International Organizations of 
Medical Sciences 2002), ICH Guidelines for Good Clinical Practices, and the Declaration of 
Helsinki.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
80(88)
10.2.Patientdata protection
The Informed Consent Form will incorporate (or, in some cases, be accompanied by a 
separate document incorporating) wording that complies with relevant data protection and 
privacy legislation.
All parties will ensure protection of subject personal data and will not include subject names 
or other identifiable data in any reports, publications, or other disclosures, except where 
required by law. 
When study data are compiled for transfer to Pfizer and other authorized parties, subject 
names, addresses, and other identifiable data will be replaced by numericalcodes based on a 
numbering system provided by Pfizer in order to de-identify study subjects.  The investigator 
site will maintain a confidential list of subjects who participated in the study, linking each 
subject’s numerical code to his or her actual identity.  In case of data transfer, Pfizer will 
maintain high standards of confidentiality and protection of subjects’ personal data consistent 
with applicable privacy laws.
10.3.Ethics and regulatory review
An IRB/IEC should approve the final study protocol, including the final version of the 
Informed Consent Form and any other written information and/or materials to be provided to 
the patients.  The investigator will ensure the distribution of these documents to the applicable 
IRB/IEC, and to the study site staff.  All correspondence with the IRB/EC should be retained 
in the investigator file.  Copies of IRB/EC approvals should be forwarded to Pfizer or its 
representative.
The opinion of the IRB/IEC should be given in writing.  The investigator should submit the 
written approval to the Sponsorbefore enrolment of any patient into the study. 
The IRB/IEC should approve all advertising used to recruit patients for the study.
The Sponsorshould approve any modifications to the Informed Consent Form that are needed 
tomeet local requirements.
If required by local regulations, the protocol should be re-approved by the IRB/IEC annually.
Before enrolment of any patient into the study, the final study protocol, including the final 
version of the Informed Consent Form, is approved by the national regulatory authority or a 
notification to the national regulatory authority is done, according to local regulations.  The 
IRB/IEC or CA must approve any recruiting materials before use; and subsequent amended 
protocols and corresponding ICFs, before instituting amendment-specified changes to the 
study, unless required for patient safety.  The only circumstance in which an amendment may 
be initiated prior to IRB/EC approval is where the change is necessary to eliminate apparent 
immediate hazards to the subjects.  In that event, the investigator must notify the IRB/EC and 
Pfizer in writing immediately after the implementation.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
81(88)
The Sponsoror its representativewill handle the distribution of any of these documents to the 
national regulatory authorities.
The Sponsor or its representativewill provide Regulatory Authorities, Ethics Committees and 
PIs with safety updates/reports according to local requirements.
The investigator is responsible for informing the IRB/IEC or CA of any changes made to the 
protocol, and for advisingthe IRB/IEC or CA, at least once a year, about the progress of the 
study. 
Each PI is responsible for providing the IRB/IEC with reports of any serious and unexpected 
adverse drug reactions from any other study conducted with the IP.  The Sponsor or its 
representativewill provide this information to the PI so that he/she can meet these reporting 
requirements.
10.4.Informed consent
This study will be conducted in compliance with current ICH E6GCP pertaining to informed 
consent, the current CFR (Title 21, Parts 50Subparts B and D, 56and 312).  The informed 
consentdocuments and any subject recruitment materials must be in compliance with ICH 
GCP, local regulatory requirements, and legal requirements, including applicable privacy 
laws.  The Principal Investigator(s) at each centrewill:
Ensure each patient
's parent(s) or legally-acceptable representative(s) is given full and 
adequate oral and written information about the nature, purpose, possible risk and 
benefit of the study
Ensure each patient
's parent(s) or legally-acceptable representative(s) is notified that 
their child is free to discontinue from the study at any time
Ensure each patient
's parent(s) or legally-acceptable representative(s) is given the 
opportunity to askquestions and allowed time to consider the information provided
Ensure each patient
's parent(s) or legally-acceptable representative(s) provides signed 
and dated informed consent before conducting any procedure specifically for the study
Ensure the original, signed Informed Consent Form(s) is/are stored in the 
investigator’s Study File and is available for verification by the Sponsor or Sponsor 
representative at any time
Ensure a copy of the signed Informed Consent Form is given to the patient
's parent(s) 
or legally-acceptable representative(s)
If applicable, the ICF will be provided in certified translation for non-English-speaking 
parent(s) or other legally-acceptable representative(s)
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
82(88)
Ensure that any reimbursement for study visitsas well as any provisions for patients 
harmed as a consequence of study participation are described in the informed consent 
form that is approved by an Ethics Committee.
10.5.Changes to the protocol and informed consent form
Study procedures will not be changed without the mutual agreement of the International 
Co-ordinating Investigator and the Sponsor.
If there are any substantial changes to the study protocol, then these changes will be 
documented in a study protocol amendment, and where required in a new version of the study 
protocol (Revised Clinical Study Protocol).
The amendment is to be approved by the relevant Ethics Committee and, if applicable, the 
national regulatory authority before implementation.  Local requirements are to be followed 
for revised protocols.
Pfizer or its representativewill distribute any subsequent amendments and new versions of the 
protocol to each PI(s).  For distributionto Ethics Committee see Section 10.3.
If a protocol amendment requires a change to a centre
's Informed Consent Form, the Sponsor 
or its representativeand the centre
's Ethics Committee are to approve the revised Informed 
Consent Form before the revised form is used. 
If local regulations require, any administrative change will be communicated to or approved 
by each Ethics Committee.
10.6.Audits and inspections
Pfizer or its agent will conduct periodic monitoring visits during study conduct to ensure that 
the protocol and Good Clinical Practices (GCPs) are being followed.  The monitors may 
review source documents to confirm that the data recorded on CRFs are accurate.  The 
investigator and institution will allow Pfizer monitors/auditors or its agents and appropriate 
regulatory authorities direct access to source documents to perform this verification.  This 
verification may also occur after study completion.
During study conduct and/or after study completion, authorized representatives of Pfizer, or 
companies working on behalf of Pfizer, a regulatory authority, or anIRB/ECmay perform 
audits or inspections at the centre, including source data verification.  The purpose of an audit 
or inspection is to systematically and independently examine all study-related activities and 
documents, to determine whether these activities were conducted, and data were recorded, 
analysed, and accurately reported according to the protocol, GCP, guidelines of the ICH, and 
any applicable regulatory requirements.  The investigator(s)will notify Pfizer or its agents
immediately if contacted by a regulatoryagency about an inspection at the centre.  
Furthermore, the investigator will cooperate with Pfizer or its agents to prepare the 
investigator site for the inspection and will allow Pfizer or its agent, whenever feasible, to be 
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
83(88)
present during the inspection.  The investigator site and investigator will promptly resolve any 
discrepancies that are identified between the study data and the subject
's medical records.  The 
investigator will promptly provide copies of the inspection findings to Pfizer or its agent.  
Before response submission to the regulatory authorities, the investigator will provide Pfizer 
or its agents with an opportunity to review and comment on responses to any such findings.
The investigator will allow the Sponsor or Sponsor representative and applicable regulatory 
authorities to inspect facilities and records relevant to this study.  It is important that the 
investigator(s) and their relevant personnel are available during the monitoring visits and 
possible audits or inspections and that sufficient time is devoted to the process.
10.7.Reporting of safety issues and serious breaches of the protocol or ICH GCP
In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable 
regulatory authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of the investigational 
product, Pfizer should be informed immediately. 
In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study subjects against any immediate hazard, and of 
any serious breaches of this protocol or of ICH GCP that the investigator becomes aware of.
10.8.Publication of study results
10.9.Communication of results by the Sponsor
Pfizer fulfills its commitment to publicly disclose clinical trial results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the European Clinical Trials 
Database (EudraCT), and/or www.pfizer.com, and other public registries in accordance with 
applicable local laws/regulations. 
In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and 
complete manner and are reported regardless of the outcome of the study or the country in 
which the study was conducted.
www.clinicaltrials.gov
Pfizer posts clinical trial US Basic Results on www.clinicaltrials.gov for Pfizer-sponsored 
interventional studies (conducted in patients) that evaluate the safety and/or efficacy of a 
Pfizer product, regardless of the geographical location in which the study is conducted.  US 
Basic Results are submitted for posting within 1year of the primary completion date (PCD) 
for studies in adult populations or within 6months of the PCD for studies in pediatric 
populations.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
84(88)
PCD is defined as the date that the final subject was examined or received an intervention for 
the purposes of final collection of data for the primary outcome, whether the clinical study 
concluded according to the prespecified protocolor was terminated.
EudraCT
Pfizer posts European Union (EU) Basic Results on EudraCT for all Pfizer-sponsored 
interventional studies that are in scope of EU requirements.  EU Basic Results are submitted 
for posting within 1year of the PCD for studies in adult populations or within 6months of the 
PCD for studies in pediatric populations.
www.pfizer.com
Pfizer posts Public Disclosure Synopses (clinical study report synopses in which any data that 
could be used to identify individual patients has been removed) on www.pfizer.com for 
Pfizer-sponsored interventional studies at the same time the US Basic Results document is 
posted to www.clinicaltrials.gov.
10.9.1.Publications by investigators
Pfizer supports the exercise of academic freedom and has no objection to publication by the 
principal investigator (PI) of the results of the study based on information collected or 
generated by the PI, whether or not the results are favorable to the Pfizer product.  However, 
to ensure against inadvertent disclosure of confidential information or unprotected inventions, 
the investigator will provide Pfizer an opportunity to review any proposed publication or other 
type of disclosure of the results of the study (collectively, “publication”) before it is submitted 
or otherwise disclosed.
The investigator will provide any publication to Pfizer at least 30days before it is submitted 
for publication or otherwise disclosed.  If any patent action is required to protect intellectual 
property rights, the investigator agrees to delay the disclosure for a period not to exceed an 
additional 60days.
The investigator will, on request, remove any previously undisclosed confidential information 
before disclosure, except for any study-or Pfizer product-related information necessary to the 
appropriate scientific presentation or understanding of the study results.
If the study is part of a multicenter study, the investigator agrees that the first publication is to 
be a joint publication covering all investigator sites, and that any subsequent publications by 
the PIwill reference that primary publication.  However, if a joint manuscript has not been 
submitted for publication within 12months of completion or termination of the study at all 
participating sites, the investigator is free to publish separately, subject to the other 
requirements of this section.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
85(88)
For all publications relating to the study, the institution will comply with recognized ethical 
standards concerning publications and authorship, including Section II -“Ethical 
Considerations in the Conduct and Reporting of Research” of the Uniform Requirements for 
Manuscripts Submitted to Biomedical Journals, http://www.icmje.org/index.html#authorship, 
established by the International Committee of Medical Journal Editors.
Publication of study results is also provided for in the CSA between Pfizer and the institution.  
In this section entitled Publications by Investigators, the defined terms shall have the 
meanings given to them in the CSA.
If there is any conflict between the CSA and any attachments to it, the terms of the CSA 
control.  If there is any conflict between this protocol and the CSA, this protocol will control 
as to any issue regarding treatment of study subjects, and the CSA will control as to all other 
issues.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
86(88)
11.LIST OF REFERENCES
1.
BlackRE, Cousens S, Johnson HL, et al.  Global, regional, and national causes of child 
mortality in 2008: a systematic analysis.  Lancet 2010;375:1969-87.
2.
Bradley JS, Nelson JD, Barnett ED, et al, editors.  2016Nelson’s pediatric antimicrobial 
therapy.  22nded.  United States: American Academy of Pediatrics; 2016.p 21-43.
3. European Commission.  Ethical considerations for clinical trials on medicinal products 
conducted with the paediatric population: Recommendations of the ad hoc group for the 
development of implementing guidelines for Directive 2001/20/EC relating to good 
clinical practice in the conduct of clinical trials on medicinal products for human use.  
2008.  Available from: http://ec.europa.eu/health/files/eudralex/vol-
10/ethical_considerations_en.pdf.  Accessed 2013 May 20.
4.
Fisher RG, Boyce TG.  Perinatal syndromes.  Moffet’s pediatric infectious diseases: a 
problem-oriented approach.  4th Ed.  Philadelphia, PA: Lippincott Williams & Wilkins; 
2005.  p 645-51.
5.
Flamm RK, Sader HS, Farrell DJ, et al.  Summary of ceftaroline activity against 
pathogens in the United States, 2010: report from the Assessing Worldwide 
Antimicrobial Resistance Evaluation (AWARE) surveillance program.  Antimicrob 
Agents Chemother 2012;56:2933-40
6.
Howie SR.  Blood sample volumes in child health research: review of safe limits.  Bull 
World Health Organ 2011;89:46-53.
7.
Kuczmarski RJ, Ogden C, Grummer-Strawn L, et al. CDC Growth Charts: United States. 
Advance Data Report No. 314. Vital and Health Statistics of the Centers for Disease 
Control and Prevention, National Center for Health Statistics, 2000
8.
Lukacs SL, Schrag SJ.  Clinical sepsis in neonates and young infants, United States, 
1988 2006.  J Pediatr 2012;160:960-5.
9.
Lutsar I, Trafojer UM, Heath PT, et al.  Meropenem vs standard of care for treatment of 
late onset sepsis in children of less than 90 days of age: study protocol for a randomised 
controlled trial.  Trials 2011;12:215.
10. Muller-Pebody B, Johnson AP, Heath PT, et al.  Empirical treatment of neonatal sepsis: 
are the current guidelines adequate? Arch Dis Child Fetal Neonatal Ed 2011;96:F4-8.
11. Nizet V, Klein JO.  Bacterial sepsis and meningitis.  In: Remington JS, Klein JO, Wilson 
CB, et al, editors.  Infectious diseases of the fetus and newborn infant.  7th ed.  
Philadelphia, PA: Elsevier; 2011.  p 226-78.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
87(88)
12. OlsenIE, GrovemanSA, LawsonML, ClarkRH, ZemelBS.New Intrauterine Growth 
Curves Based on United States Data. Pediatrics 2010;125(2):e214-24
13. Riccobene TA, Khariton T, Knebel W, Das S, Li J,  Jandourek A, Carrothers TJ, Bradley 
JS. Population PK Modeling and Target Attainment Simulations to Support Dosing of 
Ceftaroline Fosamil in Pediatric Patients with ABSSSI and CABP. J Clin Pharmacol. 
2016 Aug 11. doi: 10.1002/jcph.809. [Epub ahead of print] PubMed PMID: 27510635.
14. Rivera AM, Boucher HW.  Current concepts in antimicrobial therapy against select gram 
positive organisms: methicillin-resistant Staphylococcus aureus, penicillin-resistant 
pneumococci, and vancomycin-resistant enterococci [review].  Mayo Clin Proc 
2011;86:1230-43.
15. Rubin LG, Sanchez PJ, Siegel J, et al.  Evaluation and treatment of neonates with 
suspected late-onset sepsis: a survey of neonatologists
' practices.  Pediatrics 
2002;110:e42.
16. Sivanandan S, Soraisham AS, Swarnam K.  Choice and duration of antimicrobial therapy 
for neonatal sepsis and meningitis.  Int J Pediatr 2011;2011:712150.
17. Smith PB, Benjamin DK Jr.  Clinical approach to the infected neonate.  In: Long SS, 
Pickering LK, Prober CG, editors.  Principles and practice of pediatric infectious 
diseases.  4th ed.  Philadelphia, PA: Elsevier; 2012.  p 536-8.
18. Teflaro®(ceftaroline fosamil) [prescribing information].  Allegan; 2016.  Available from: 
http://www.allergan.com/assets/pdf/teflaro_pi.  Accessed 17 Aug 2016.
19. Zinforo™(ceftaroline fosamil) [summary of product characteristics].  Bedfordshire, 
United Kingdom: AstraZeneca UK Limited; 2016.  Available from: 
https://www.medicines.org.uk/emc/medicine/26988.  Accessed 17Aug 2016.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

Clinical Study Protocol 
Drug Substance Ceftaroline fosamil
Study Code D3720C00009/C2661002
Version 5.0
Date 25 May 2017
88(88)
APPENDIXA
INTERNATIONAL AIRLINE TRANSPORTATION 
ASSOCIATION (IATA) 6.2GUIDANCE DOCUMENT
Labelling and shipment of biohazard samples
International Airline Transportation Association (IATA) classifies biohazardous agents into 
3categories.  For transport purposes the classification of infectious substances according to 
risk groups was removed from the Dangerous Goods Regulations (DGR) in the 46th edition 
(2005).  Infectious substances are now classified either as Category A, Category B or Exempt.  
There is no direct relationship between Risk Groups and categories A and B.
Category AInfectious Substancesare infectious substances in a form that, when exposure to 
it occurs, is capable of causing permanent disability, life-threatening or fatal disease in 
otherwise healthy humans or animals.  Category A pathogens are eg, Ebola, Lassa fever virus:
are to be packed and shipped in accordance with IATA Instruction 602.
Category B Infectious Substancesare infectious Substances that do not meet the criteria for 
inclusion in Category A.  Category B pathogens are eg, Hepatitis A, B, C, D, and E viruses, 
Human immunodeficiency virus (HIV) types 1and 2.  They are assigned the following UN 
number and proper shipping name:
UN 3373–Biological Substance, Category B
are to be packed in accordance with UN3373and IATA 650
Exempt -all other materials with minimal risk of containing pathogens
Clinical trial samples will fall into Category B or exempt under IATA regulations
Clinical trial samples will routinely be packed and transported at ambient temperature 
in IATA 650compliant packaging 
Biological samples transported in dry ice require additional dangerous goods 
specification for the dry-ice content
IATA compliant courier and packaging materials should be used for packing and 
transportation and packing should be done by an IATA certified person, as applicable
Samples routinely transported by road or rail are subject to local regulations which require 
that they are also packed and transported in a safe and appropriate way to contain any risk of 
infection or contamination by using approved couriers and packaging / containment materials 
at all times.  The IATA 650biological sample containment standards are encouraged 
wherever possible when road or rail transport is used.
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)

DocumentApprovalRecord
DocumentName:
DocumentTitle:
SignedBy:
Date(GMT)
SigningCapacity
PPD
PPD
090177e18e70652a\0.1\Draft\Versioned On:28-May-2018 06:13 (GMT)