MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalised for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated With Zinforo (REGISTERED) (Ceftaroline Fosamil) in a Usual Care Setting
Conditions: Community Acquired Pneumonia, Complicated Skin and Soft Tissue Infection
Sponsor: Pfizer

Ceftaroline Fosamil (Zinforo®) 
C2661041 NON-INTERVENTIONAL STUDY PROTOCOL, Amendment 1
Final version 2.0, 19 July 2019 
PFIZER CONFIDENTIAL
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NON-INTERVENTIONAL (NI) STUDY PROTOCOL
MULTINATIONAL Retrospective Chart Review Study to Assess the 
Characteristics, Treatment Outcomes and Resource Use Among Adult 
Patients Hospitalised for Community-Acquired Pneumonia (CAP) or
Complicated Skin and Soft Tissue Infections (cSSTI) Treated with Zinforo®
(ceftaroline fosamil) in a Usual Care Setting 
This document contains confidential information belonging to Pfizer.  Except as otherwise agreed to in 
writing, by accepting or reviewing this document, you agree to hold this information in confidence and not 
copy or disclose it to others (except where required by applicable law) or use it for unauthorized purposes.  In 
the event of any actual or suspected breach of this obligation, Pfizer must be promptly notified.

Ceftaroline Fosamil (Zinforo®) 
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PFIZER CONFIDENTIAL
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Study Information
Title
Multinational Retrospective Chart Review 
Study to Assess the Characteristics, 
Treatment Outcomes and Resource Use 
Among Adult Patients Hospitalised for 
Community-Acquired Pneumonia (CAP) 
and Complicated Skin and Soft Tissue 
Infections (cSSTI) Treated With Zinforo®
(ceftaroline fosamil) in a Usual Care Setting 
Protocol number
C2661041
Protocol version identifier
2.0
Date of last version of protocol
19 July 2019
Active substance
Other cephalosporins (ATC Code: J01DI02)
Medicinal product
Ceftaroline fosamil (Zinforo)®
Research question and objectives
Primary Objective:
To provide real world evidence (RWE) on 
the characteristics, clinical management, 
treatment outcomes and healthcare resource 
use of adult patients aged 18 years and older 
admitted to the hospital for CAP or cSSTI 
who received Zinforo® in usual care before 
31-May-2019 in Europe and Latin America.
Authors
 Ph.D.
 MHA
PPD
PPD
PPD
PPD

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1. TABLE OF CONTENTS
1. TABLE OF CONTENTS.......................................................................................................3
2. LIST OF ABBREVIATIONS................................................................................................5
3. RESPONSIBLE PARTIES....................................................................................................7
4. ABSTRACT...........................................................................................................................8
5. AMENDMENTS AND UPDATES.....................................................................................13
6. MILESTONES.....................................................................................................................14
7. RATIONALE AND BACKGROUND................................................................................14
8. RESEARCH QUESTION AND OBJECTIVES .................................................................15
9. RESEARCH METHODS ....................................................................................................16
9.1. Study Design ...........................................................................................................16
9.2. Setting......................................................................................................................16
9.2.1. Inclusion Criteria ........................................................................................17
9.2.2. General Exclusion Criteria .........................................................................18
9.3. Variables..................................................................................................................19
9.4. Data Sources............................................................................................................22
9.5. Study Size................................................................................................................22
9.6. Data Management ...................................................................................................22
9.6.1. Case Report Form (CRF)/Data Collection Tool (DCT)/Electronic 
Data Record .....................................................................................................23
9.6.2. Record Retention ........................................................................................23
9.7. Data Analysis ..........................................................................................................24
9.8. Quality Control........................................................................................................24
9.9. Limitations of the Research Methods......................................................................25
9.10. Other Aspects ........................................................................................................25
10. PROTECTION OF HUMAN SUBJECTS ........................................................................25
10.1. Patient Information................................................................................................25
10.2. Patient Consent......................................................................................................26
10.3. Patient Withdrawal................................................................................................27
10.4. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ............27
10.5. Ethical Conduct of the Study ................................................................................27
11. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS ......................................................................................................................27

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12. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS........29
13. REFERENCES ..................................................................................................................30
14. LIST OF TABLES.............................................................................................................33
15. LIST OF FIGURES ...........................................................................................................33
ANNEX 1. LIST OF STAND ALONE DOCUMENTS .........................................................34
ANNEX 2. ENCEPP CHECKLIST FOR STUDY PROTOCOLS .........................................34
ANNEX 3. ADDITIONAL INFORMATION.........................................................................35

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2. LIST OF ABBREVIATIONS
Abbreviation
Definition
ABSSSI
Acute Bacterial Skin and Skin Structure Infections
AE
Adverse event
CABP
Community-Acquired Bacterial Pneumonia 
CAP
Community-Acquired Pneumonia
CRF
Case report form
cSSTI
Complicated Skin and Soft Tissue Infections 
eCRF
Electronic Case Report Form
EDC
Electronic Data Collection
EMA
European Medicines Agency
GPP
Good Pharmacoepidemiology Practices
HIPAA
Health Insurance Portability and Accountability Act
ICF
Informed consent form
ICU
Intensive Care Unit
ICMJE
International Committee of Medical Journal Editors
IEC
Independent Ethics Committee
IRB
Institutional review board
ISPE
International Society for Pharmacoepidemiology
IV
Intravenous
MIC
Minimum Inhibitory Concentration
MDR
Multidrug Resistant
RWD
Real World Data
RWE
Real World Evidence

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Abbreviation
Definition
RWESA
Real World Evidence Stragety and Analytics
SAP
Statistical Analysis Plan
SOFA
Sequential Organ Failure Assessment
US
United States
WBC
White Blood Cell

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3. RESPONSIBLE PARTIES
Author(s) of the Protocol
Name, degree(s)
Title
Affiliation
Address
 PhD
 
 
 USA
 
MHA
 
Canada 
 MPH
Pfizer Inc.
235 East 42nd Street
New York, NY 10017
USA
 
PhD
 
Pfizer Inc.
500 Arcola Road 
Collegeville, PA 19426 
USA
 MD
Pfizer Inc.
23-25 Avenue du Dr 
Lannelongue, 75668 
Paris, France
 
MSPH
Pfizer Inc.
500 Arcola Road 
Collegeville, PA 19426 
USA
Scientific Advisory Committee for the Protocol
Name, degree(s)
Affiliation
City
Country
 MD
Spain
 MD
Italy
 MD
 
Italy
 MD
 
Greece
 MD
 
 
France
PPD
PPD
PPD
PPD
PPD
P
P
D
PPD
PPD
PPD
PPD
PPD
PPD
P
P
D
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD

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4. ABSTRACT
Title:
Multinational Retrospective Chart Review Study to Assess the 
Characteristics, Treatment Outcomes and Resource Use Among 
Adult Patients Hospitalised for Community-Acquired Pneumonia 
(CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) 
Treated With Zinforo® (ceftaroline fosamil) in a Usual Care Setting 
Version 2.0; 19 July 2019
Rational and 
background:
cSSTI represents a major clinical problem1,2,3 and is associated with 
considerable morbidity, mortality, resource use and healthcare 
costs.4-9 Current treatment options are compromised by resistance 
and tolerability issues.  CAP is a common respiratory illness10-16 that 
is also associated with considerable morbidity, mortality,15,17,18
resource use and healthcare costs.11,14,18,19
In patients with CAP and cSSTI (particularly those at risk of 
treatment failure), there is a need for an alternative treatment option 
that will improve empiric treatment success rates by providing 
activity against a range of suspected causative pathogens (including 
MRSA and S. pneumoniae) combined with a good tolerability profile. 
Ceftaroline fosamil (Zinforo®) is a novel 5th generation 
cephalosporin with rapid bactericidal action against a broad range of 
common Gram positive and Gram negative pathogens.  Zinforo- is
approved in the EU in adults and children from the age of two (2)
months for the treatment of complicated skin and soft tissue 
infections (cSSTI) and community-acquired pneumonia (CAP).  
For the treatment of cSSTI and CAP, the recommended dose of 
Zinforo® is 600 mg administered every 12 hours by intravenous 
infusion over 60 minutes (standard dose). For the treatment of adult 
patients with cSSTI confirmed or suspected to be caused by S. aureus 
with a Minimum Inhibitory Concentration (MIC) = 2 mg/L or 4 mg/L 
to ceftaroline, the dose of Zinforo® is 600 mg administered every 
8 hours by intravenous infusion over 120 minutes (high dose). The 
recommended treatment duration for cSSTI is 5 to 14 days and the 
recommended duration of treatment for CAP is 5 to 7 days.  
Zinforo® is an effective treatment for patients hospitalised with CAP 
or cSSTI, including those at risk of treatment failure and/or with 
intolerance/contraindications to commonly-used antibiotics.20,29, 30-32, 
33 At present, the real-world use and effectiveness of Zinforo® in
treating patients hospitalized with CAP and cSTTI has not been 
evaluated in a usual care setting in Europe and Latin America.

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Research question 
and objectives:
Study Aim:
The overall study aim is to provide real world evidence (RWE) on 
the characteristics, clinical management, treatment outcomes and 
healthcare resource use of adult patients aged 18 years and older 
admitted to the hospital for CAP or cSSTI who received Zinforo®
in a usual care setting in Europe and Latin America on or before 
31-May-2019.
Specific Objectives:

To describe the characteristics of patients hospitalized for 
CAP or cSSTI who received Zinforo® in a usual care setting
in Europe and Latin America on or before 31-May-2019;  

To describe physicians’ use of Zinforo® in the clinical 
management of patients hospitalized for CAP or cSSTI in 
relation to their use of other antibiotics (first-line vs.
second-line/salvage, monotherapy vs. combination therapy, 
empiric vs. definitive therapy);

To estimate the proportion of patients hospitalized for CAP 
or cSSTI who responded to Zinforo® (clinical response 
defined as no further intravenous (IV) antibiotic, switch to 
an oral antibiotic, or IV antibiotic treatment 
streamlining/de-escalation prior to discharge from the 
hospital);

To estimate the proportion of patients hospitalized for CAP 
or cSSTI who had treatment modification of Zinforo®
(defined as switch to another IV antibiotic due to an adverse 
reaction, drug-drug interaction, insufﬁcient response or a 
microbiological diagnosis indicating that the pathogen is 
not susceptible to Zinforo);®

To describe the clinical outcomes (eg, hospital readmission, 
mortality) of patients hospitalized for CAP or cSSTI after 
starting Zinforo® stratified by clinical response;

To describe the healthcare resource use of patients 
hospitalized for CAP or cSSTI after starting Zinforo®
stratified by clinical response.
Study design:
Multinational, multicenter observational retrospective cohort study
Population:
The target population is adult patients aged 18 years and older 
hospitalized for CAP or cSSTI who received intravenous (IV) 

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Zinforo® treatment in a usual care setting in Europe and Latin 
America on or before 31-May-2019.
Inclusion criteria:
1. Age 18 years or older at admission date to the hospital.
2. Received four (4) or more consecutive IV doses of Zinforo®
in usual care on or before 31-May-2019; and 
3. Admitting diagnosis to the hospital was either CAP or 
cSSTI.
Exclusion criteria:
1. Patients who were participating in an interventional clinical 
trial during the same hospital admission in which Zinforo®
was administered.
2. Patients whose hospital medical records are missing 
documentation of the diagnostic criteria for either cSSTI or 
CAP.
3. Patients whose hospital medical records are missing details 
of dosing with Zinforo.®
4. Patients whose hospital medical records are missing 
information on the success/failure of Zinforo® treatment
and the reason why treatment was discontinued; and
5. Patients whose hospital medical records are missing 
discharge date and status information.
Variables 
The following data will be collected:

Site Information (country, type of site, hospital size, 
participating department); 

Patient Demographics (sex, age, ethnic origin, height, 
weight, type of residence/co-habitation, smoking habits);

Medical History (diabetes, respiratory disease,
cancer/malignancy, peripheral vascular disease, congestive 
heart failure, immunosuppressive therapy in the 3 months 
prior to hospitalization, hospitalization in the prior 
3 months, other relevant conditions, multidrug resistance 
risk score at admission, quick sequential organ failure 

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assessment score at admission);

Disease Characteristics for CAP (time from diagnosis to 
Zinforo initiation, diagnostic criteria met, imaging findings 
suggestive of bacterial pneumonia, signs of acute illness at 
diagnosis);

Disease characteristics for cSSTI (time from diagnosis to 
initiation of Zinforo diagnostic criteria met, 
cellulitis/fasciitis, abscess, post-traumatic wound, 
post-surgical wound, diabetic leg ulcer, peripheral vascular 
disease ulcer, lesion size, lower extremities affected, 
swelling/induration, skin necrosis, recurrent skin infection 
episode, nosocomial infection);

Hospitalization Information (duration of hospitalization, 
discharge destination, discharge status, ICU duration, ICU
discharge date);

Microbiological Diagnosis (investigations or diagnostic 
tests performed, positive microbiological diagnosis 
obtained, microorganism name, bacteremia diagnosed);

Zinforo® Treatment (treatment duration, line of therapy, 
time from hospital admission to first dose, empiric vs.
definitive therapy, monotherapy vs. combination therapy, 
daily dose, number of doses administered, treatment 
duration, clinical response, clinical response definition 
(Halm criteria, switch to oral antibiotic, other) time to 
clinical response (days), treatment streamlining/de-
escalation, treatment modification, time to treatment 
modification (days), reason for treatment modification, ICU 
vs. general medical ward administration);

All Other Antibiotic Treatments during the index hospital 
admission (each monotherapy/combination antibiotic 
therapy name, line of therapy, route of administration, 
duration of treatment, number of doses administered,
treatment response, time to treatment modification from 
initial dose (days), reason for treatment modification, ICU 
vs. general medical ward administration);

Clinical Outcomes and Healthcare Resource Use after first 
Zinforo® dose (number of days in the hospital, switch to 
another IV antibiotic, switch to an oral antibiotic, time to 
first oral antibiotic dose, admission to ICU, time in ICU, 

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mechanical ventilation, surgery, reinfection or recurrence, 
acute renal failure, length of acute renal failure, blood 
pressure support, fluid resuscitation, vasopressors, septic 
shock, isolation required, parenteral nutrition, length of 
parental nutrition, home-based care after discharge, in-
hospital mortality, 30-day mortality, 30-day readmission 
after discharge).
Data sources
Data will be retrospectively extracted from the hospital medical 
records of eligible patients. De-identified data will be collected 
following the Health Insurance Portability and Accountability 
Act (HIPAA)-compliant safe harbor approach.34
Study size
The target sample for recruitment is approximately 600 patients
across all sites.  The number of eligible CAP and cSSTI patients 
that each site will provide will vary depending on the historical 
usage of Zinforo® at that site up to 31-May-2019.
Data analyses
The objective of this retrospective chart review study is descriptive 
in nature; therefore, no hypothesis testing will be performed. The 
results of the total study sample will be summarized using 
descriptive statistics. Data will be summarized by means, standard 
deviations (SD), medians, minimums and maximums for 
continuous variables; and by numbers and percentages for 
categorical variables.  All summarized data will be presented in 
aggregate, and may be stratified by covariates of interest if a 
subgroup has a minimum sample size of 30 patients (5% of total 
study size). 
Clinical outcomes and resource use following the initiation of 
Zinforo® treatment will be assessed according to patients’ observed 
clinical response time (<72-hours, >72-hours, no response).  The 
mean (SD) and median times to an outcome of interest (eg, length 
of stay in the hospital measured in days) will be calculated in each 
patient subgroup.
Milestones
Completion of feasibility assessment: 15 September 2019.
Start of data collection: 01 December 2019.
End of data collection: 15 June 2020.
Final study report: 12 October 2020.

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5. AMENDMENTS AND UPDATES
Amendment 1. The study has been updated to expand into Latin America, increasing the 
sample size from 300 over all sites to approximately 600 patient charts. Additionally, this 
amendment details an anonymized data collection approach where a waiver of consent will 
be requested of Institutional review board (IRBs)/Independent ethics committees(IECs). 
Finally, the recruitment period has been extended to 31 May 2019. 
Amendment 
number
Date
Protocol 
section(s) 
changed
Summary of 
amendment(s)
Reason
1
19-July-
2019
4; 9
Expansion into Latin 
America; increase in 
sample size and 
number of sites.
Anonymzed data 
collection approach
Extended recruitment 
period
Expanded area of interest for 
Pfizer.
To help increase likelihood of 
IRB/IEC’s granting the waiver 
of consent. A waiver is 
requested to mitigate the risk of 
sampling bias that may be 
introduce of consent is 
required.
Allow for additional data to be 
entered given the change in 
study timelines.

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6. MILESTONES
Milestone
Planned date
Completion of feasibility assessment
15 September 2019
Start of data collection 
01 December 2019
End of data collection
15 June 2020
Completion of data analysis
10 August 2020
Final study report
12 October 2020
7. RATIONALE AND BACKGROUND
Community-acquired pneumonia (CAP) is an acute infection of the lungs for which 
symptoms include cough, fever and chest pain.35 CAP is a common respiratory illness10-16
that is also associated with considerable morbidity, mortality,15,17,18 resource use and 
healthcare costs.11,14,18,19 It is recognized as a leading cause of hospital mortality, for which 
the incidence appears to be rising.36,37
CAP is associated with high patient burden and health resource utilisation including a 
rehospitalisation rate of up to 20% and a 30-day mortality rate of 23% with elderly patients 
considered higher risk.36 Prognosis factors for CAP are thought to be age, severity and
comorbidities such as diabetes, while factors related to CAP in-hospital death include 
comorbidities, age, readmission and mechanical ventilation.37,38
Ceftaroline fosamil (Telflaro in the United States [US]; Zinforo® ex-US) is a pro-drug of 
ceftaroline, which is a broad-spectrum antibiotic with in vitro activity against a range of 
Gram-positive and Gram-negative bacteria commonly associated with CAP or cSSTI.  
Importantly, ceftaroline is active against resistant phenotypes commonly isolated in CAP 
including penicillin-resistant S. pneumoniae (PRSP), multidrug-resistant S. pneumoniae, 
methicillin-resistant S. aureus (MRSA), and vancomycin-resistant S. aureus (VRSA).
Complicated skin and soft tissue infections (cSSTIs) include infected ulcers, infected burns 
and major abscesses that require hospitalization among patients who typically are elderly and 
have underlying comorbidities such as diabetes mellitus, peripheral vascular disease and 
obesity.  The most common etiologic pathogen in cSSTI is Staphylococcus aureus, including 
MRSA. cSSTI represents a major clinical problem1,2,3 and is associated with considerable 
morbidity, mortality, resource use and healthcare costs.4-9 Current treatment options are 
compromised by resistance in particular countries and tolerability issues.
In patients with CAP or cSSTI (particularly those at risk of treatment failure), there is a need 
for an alternative treatment option that will improve empiric treatment success rates by 
providing activity against a range of suspected causative pathogens (including MRSA and 
S. pneumoniae) combined with a good tolerability profile.

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Ceftaroline fosamil (Teflaro) was approved by the FDA in 2011 for the indications of 
community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure 
infections (ABSSSI).  The Clinical Assessment Program and TEFLARO Utilization Registry 
(CAPTURE) is a multicenter retrospective chart review study conducted at 33 hospitals 
during the first year that Teflaro was marketed in the United States. The sub-study of 
intravenous Teflaro for ABSSSI collected data from August 2011 to August 2012 among 
647 patients who had non-missing data on treatment outcome.33 Among these patients, 
85% (550/647) showed clinical success with Teflaro treatment.  The CAPTURE sub-study of 
intravenous Teflaro for CABP collected data from August 2011 to July 2012 among 
398 patients who had non-missing data on treatment outcome.23 The overall clinical success 
proportion was 79% (316/398) in this cohort.  These data demonstrated that Teflaro, when 
administered in a “real world” usual clinical care setting at US hospitals, is an effective 
antibiotic treatment for patients with CABP or ABSSSI.  These data also demonstrated that 
only a small proportion of patients (2% in each sub-study) discontinued Teflaro treatment as 
a consequence of adverse events (AE).23,33
Ceftaroline fosamil (Zinforo®) was approved by the European Commission in August 2012 
for the treatment of adult patients with cSSTIs or CAP.® In April 2016, the CHMP extended 
these two indications to include children from two months old.  For the treatment of cSSTI or
CAP, the recommended dose is 600 mg administered every 12 hours by intravenous infusion 
over 60 minutes in patients aged 18 years or older (standard dose). For the treatment of adult 
patients with cSSTI confirmed or suspected to be caused by S. aureus with a MIC = 2 mg/L 
or 4 mg/L to ceftaroline, the dose of Zinforo® is 600 mg administered every 8 hours by 
intravenous infusion over 120 minutes (high dose). The recommended treatment duration for 
cSSTI is 5 to 14 days and the recommended duration of treatment for CAP is 5 to 7 days.
Zinforo® is now approved in 52 markets globally. 
Zinforo® is an effective treatment for patients hospitalised with CAP or cSSTI, including 
those at risk of treatment failure and/or with intolerance/contraindications to commonly-used 
antibiotics.20-29,30-32,33 At present, the real-world use and effectiveness of Zinforo® in treating 
patients hospitalized with CAP or cSTTI has not been evaluated in a usual care setting in 
Europe® and Latin America.
This proposed retrospective chart review study will assess the characteristics, treatment 
outcomes and resource use of patients hospitalized with CAP or cSSTIs treated with 
Zinforo® in a “real world” usual care setting in countries within Europe and Latin America.
8. RESEARCH QUESTION AND OBJECTIVES
Study Aim:
The overall study aim is to provide real world evidence (RWE) on the characteristics, clinical 
management, treatment outcomes and healthcare resource use of adult patients aged 18 years 
and older admitted to the hospital for CAP or cSSTI who received Zinforo® in a usual care 
setting in Europe and Latin America on or before 31-May-2019.

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Specific Objectives:

To describe the characteristics of patients hospitalized for CAP or cSSTI who 
received Zinforo® in a usual care setting in Europe and Latin America on or before 
31-May-2019. 

To describe physicians’ use of Zinforo® in the clinical management of patients 
hospitalized for CAP or cSSTI in relation to their use of other antibiotics (first-line
vs. second-line/salvage, monotherapy vs. combination therapy, empiric vs. definitive
therapy).

To estimate the proportion of patients hospitalized for CAP or cSSTI who responded 
to Zinforo® (clinical response defined as no further intravenous (IV) antibiotic, switch 
to an oral antibiotic, or IV antibiotic treatment streamlining/de-escalation prior to 
discharge from the hospital).

To estimate the proportion of patients hospitalized for CAP or cSSTI who had 
treatment modification of Zinforo® (defined as switch to another IV antibiotic due to 
an adverse reaction, drug-drug interaction, insufﬁcient response, or a microbiological 
diagnosis indicating that the pathogen is not susceptible to Zinforo).®

To describe the clinical outcomes (eg, hospital readmission, mortality) of patients 
hospitalized for CAP or cSSTI after starting Zinforo® stratified by clinical response.

To describe the healthcare resource use of patients hospitalized for CAP or cSSTI 
after starting Zinforo® stratified by clinical response.
9. RESEARCH METHODS 
9.1. Study Design
This will be a multinational, multicenter observational retrospective cohort study of patients 
with cSSTI or CAP treated with Zinforo® in a usual care setting. The hospital medical 
records of patients who meet the eligibility criteria will be included in this retrospective chart 
review study. A retrospective chart review study design was chosen as the most efficient 
method to generate RWE to assess patients’ experience with Zinforo® in a usual care setting 
in Europe and Latin America. The data collected in this study will be obtained in a timelier 
manner than could be achieved with a prospective study design. 
9.2. Setting
The target population will be adult patients aged 18 years and older admitted to the hospital 
with a documented clinical diagnosis of CAP or cSSTI who received four or more 
consecutive IV doses of Zinforo® on or before 31-May-2019. This study will be conducted 
in approximately 35-40 hospitals in multiple countries. 

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Hospital sites participating in this study will identify all patients dispensed four or more 
intravenous (IV) doses of Zinforo® in usual care on or before 31-May-2019 by querying their 
hospital pharmacy dispensing records.  Potentially eligible patients treated with Zinforo® for 
either CAP or cSSTI will be identified by querying hospital discharge records for diagnosis 
codes indicative of either CAP or cSSTI using the World Health Organization International 
Classification of Diseases 10th revision (ICD-10; see Annex 3 for the list of ICD-10 codes).  
The hospital medical records of potentially eligible patients treated with Zinforo® will be 
screened manually by site staff to identify the subset of eligible CAP and cSTTI patients who 
meet all inclusion criteria without meeting any of the exclusion criteria (see below).  For 
most sites, all eligible CAP and cSTTI patients treated with Zinforo® will be selected for 
chart abstraction.  For some sites with a high number of Zinforo-treated patients, the site may 
be contracted to only abstract the medical records of a prespecified number of their eligible 
patients in reverse chronological order (most recently treated patients are screened first).  The 
hospital medical records of eligible CAP and cSSTI patients will be abstracted for all clinical 
outcomes and healthcare resources utilization up to 30-days following the discharge date of 
the index hospitalization or death, whichever occurs first.
9.2.1. Inclusion Criteria
Patients must meet all of the following inclusion criteria to be eligible for this retrospective 
chart review study:
1. Age18 years or older at admission date to the hospital.
2. Received four (4) or more consecutive IV doses of Zinforo® in usual care on or 
before 31-May-2019.
3. Admitting diagnosis to the hospital was either CAP or cSSTI (see diagnostic criteria 
below).
Diagnostic Criteria for CAP: 
1. Imaging findings (X-ray, ultrasound, etc.) of the chest consistent with a diagnosis of 
bacterial pneumonia at the date of admission to the hospital.
2. Acute illness at the date of admission to the hospital with at least three of the 
following:

New or increased cough severity;

Purulent sputum or change in sputum character;

Auscultatory findings consistent with pneumonia;

Dyspnea, tachypnea, or hypoxemia (O2 saturation <90% on room air or 
pO2 <60 mm Hg);

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
Fever (>38oC oral or 38.5oC rectally or tympanically) or hypothermia (<35oC);

White blood cell (WBC) count >10,000 cells/mm3 or < 4,500 cells/mm3;

>15% bands irrespective of WBC count.
Diagnostic Criteria for cSSTI: 
1. Involvement of deeper soft tissue (eg, cellulitis, fasciitis, etc.) and/or requiring 
significant surgical intervention (such as wound infection – surgical or traumatic) or 
developing on a lower limb in a subject with diabetes mellitus or well-documented 
peripheral vascular disease, a major abscess, infected ulcer or deep or extensive 
cellulitis, or any surgical site infection.
2. At least two local signs of cSSTI (purulent or seropurulent drainage/discharge, 
erythema, fluctuance, heat/localised warmth, pain/tenderness to palpation, 
swelling/induration).
3. At least one systemic sign (temperature of >28oC, WBC count of >10,000/mm3, 
>10% immature neutrophils).
cSSTI definitions:

Cellulitis: advancing erythema, edema and heat. “Deep and extensive cellulitis” 
affecting deeper soft tissues with a surface area of >10cm2.

Significant surgical intervention: a major operative procedure, not including 
commonly performed minor procedures such as incision and drainage or minor 
abscesses performed at the bedside, suture removal, needle aspiration, superficial 
debridement of devitalized tissue or routine wound care.

Wound infection: purulent/seropurulent discharge or >5cm of erythema (ie, cellulitis) 
surrounding the wound margin.

Abscess: loculated fluid collection with >2cm of erythema (ie, cellulitis) extending 
from the abscess margin. A “major abscess” either extends to deeper soft tissue or 
requires significant surgical intervention.

Deeper soft tissue: subdermal tissue, including subcutaneous fat, eg, extension of 
infection to muscle or fascia constitutes evidence of deeper soft tissue involvement.
9.2.2. General Exclusion Criteria
Patients meeting any of the following exclusion criteria will not be eligible for this 
retrospective chart review study:
1. Patients who were participating in an interventional clinical trial during the same 
hospital admission in which Zinforo® was administered.

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2. Patients whose hospital medical records are missing documentation of the diagnostic 
criteria for either cSSTI or CAP (see above).
3. Patients whose hospital medical records are missing details of dosing with Zinforo.®  
4. Patients whose hospital medical records are missing information on the 
success/failure of Zinforo® treatment and the reason why treatment was discontinued.
5. Patients whose hospital medical records are missing discharge date and status 
information.
CAP-specific Exclusion Criteria:

Patients admitted hospital for another medical condition who developed signs and 
symptoms of hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia 
(VAP) 48-hours or more after the admission date are not eligible for this study. 
cSSTI-specific Exclusion Criteria:

Patients with uncomplicated SSTI are not eligible for this study.

Patients with skin and soft tissue infection complicated by the presence of orthopedic 
or joint replacement prostheses are not eligible for this study.

Patients with known or suspected endocarditis, osteomyelitis, or septic arthritis are 
not eligible for this study.
9.3. Variables
Below is a summary of the variables that will be collected for the index hospitalization:

Site Information (country, type of site, hospital size, participating department).

Patient Demographics (sex, age, ethnic origin, height, weight, type of 
residence/co-habitation, smoking habits).

Quick Sepsis-Related Organ Failure Assessment (qSOFA) at Admission (altererd 
mental status (Glasgow coma scale <15), low blood pressure (systolic blood pressure 
<100 mmHg), high respiration rate (>=22 breaths per minute).  Risk Factors for 
having a MDR Pathogen at Admission (chronic renal failure, cerebrovascular disease, 
diabetes, COPD, hospitalization for >=2 days in the preceding 90 days, residency in a 
nursing home or extended-care facility, home infusion therapy, home wound care, 
chronic dialysis within 30 days, immunosuppression, antimicrobial therapy in the 
preceding 90 days).

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
Medical History (other relevant comorbidities such as diabetes mellitus, respiratory 
disease, cancer/malignancy, peripheral vascular disease, congestive heart failure, 
immunosuppressive therapy in the 3 months prior to hospitalization, hospitalization in 
the prior 3 months, invasive surgical treatment in the 3 months prior to 
hospitalization, other relevant conditions or diseases requiring chronic drug 
treatment).

Disease Characteristics for CAP (time from diagnosis to Zinforo initiation, diagnostic 
criteria met, radiographic findings suggestive of bacterial pneumonia, triggering signs 
and symptoms of acute illness at diagnosis, , community versus health care 
associated, severity (PORT, CURB, other), recurrent infection (Y/N).

Disease Characteristics for cSSTI (time from diagnosis to initiation of Zinforo, 
diagnostic criteria met, triggering signs/symptoms, , primary anatomic area involved,
cellulitis/fasciitis, abscess, post-traumatic wound, post-surgical wound, diabetic leg 
ulcer, peripheral vascular disease ulcer, lesion extension >50 cm2, lower extremities
affected, swelling/induration, skin necrosis, recurrent skin infection episode, 
nosocomial infection.  For wounds: superficial vs. deeper, in joint or organ space, 
systemic inflammatory response indicators.  For cellulitis: deep/extensive).

Hospitalization Information (duration of hospitalization, discharge destination, 
discharge status, ICU admission, ICU duration).

Microbiological Diagnosis (investigations or diagnostic tests performed, positive 
microbiological diagnosis obtained, microorganism name, bacteremia diagnosed, 
the pathogen(s), source(s), and the specimen collection date(s). Pathogens 
identified by blood, respiratory (eg, sputum, bronchoalveolar lavage), or pleural 
effusion cultures will be recorded for patients with bacterial pneumonia. 
Pathogens identified by blood or skin/soft tissue/bone/wound cultures will be
recorded for patients with cSSTIs.  Minimum inhibitory concentrations (MIC) of 
antibacterial drugs for pathogens isolated from samples collected within one week 
before the start of treatment through 24 hours after discontinuation of Zinforo®
will be recorded:

MIC of ceftaroline for all isolated pathogens;

MIC of oxacillin, vancomycin, linezolid, and daptomycin for S. aureus;

MIC of ceftriaxone for MSSA;

MIC of penicillin and ceftriaxone for S. pneumoniae.

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
Zinforo® Treatment (treatment duration, line of therapy, time from hospital admission 
to first dose, time from symptom onset to first dose, empiric vs. definitive therapy, 
monotherapy vs. combination therapy, dose, number of infusions per day, number of 
doses administered, ICU vs. general medical ward administration, reason for switch 
to Zinforo® if not 1st line treatment.

Pre-Zinforo® IVAntibiotic Treatments for the index infection (each 
monotherapy/combination antibiotic therapy name, line of therapy, route of 
administration, duration of treatment, time from admission to first dose, time from 
symptom onset to first dose, empiric vs. definitive therapy, daily dose, number of 
doses administered, treatment response, time to treatment modification from initial 
dose (days), reason for treatment modification, ICU vs. general medical ward 
administration).  

Concurrent IV antibiotic treatments administered with Zinforo® for index infection
(antibiotic therapy name, route of administration, treatment duration, daily dose, 
number of doses administered).

Post-Zinforo® antibiotic treatments for index infection (antibiotic therapy name, route 
of administration, treatment duration, daily dose, number of doses administered, 
reason for switch, treatment response, ICU vs. general medical ward administration).

Zinforo® Treatment Response:  Clinical response (response definition, treatment 
de-escalation, oral switch, time to symptom resolution, time to clinical stability (Halm 
criteria), time to oral switch).  Clinical failure (treatment modification due to AE, 
DDI, or insufficient response, death due to index infection, death due to other. 
Relapse or recurrence.  Time to relapse or recurrence.

Healthcare Resource Use after date of first Zinforo® dose (number of days in the 
hospital,  admission to ICU, time in ICU, surgery, mechanical ventilation, acute renal 
failure, length of acute renal failure, blood pressure support, fluid resuscitation, 
vasopressors, septic shock, isolation required, parenteral nutrition, length of parental 
nutrition, home-based care after discharge, in-hospital mortality, 30-day mortality, 
30-day readmission after discharge, readmission for index infection, readmission for 
other reason). 
Derived variables will be calculated from the reported values of other variables entered by 
sites.  For example, type of CAP will be derived as follows:

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Variable
Role
Data source(s)
Operational definition
Type of CAP
Effect modifier
Type of residence/co-
habitation variable in 
Patient Demographics 
CRF.
CAP = Residence in 
private house or 
apartment only. 
HCAP =: residence in a 
nursing home, home 
care through a 
healthcare agency, 
previous admission to 
hospital with CAP (last 
3 months), 
haemodialysis or 
chemotherapy for active 
cancer, with the 
exception of 
immunocompromised/
immunosuppressed.
9.4. Data Sources
Data for this study will be collected by a retrospective medical chart extraction from 
participating sites. The sites will be hospitals in Europe and Latin America that have treated 
patients with CAP or cSSTI in usual care during the study period.  Approximately 
600 patient charts will be included in this study from approximately 35-40 sites in Europe
and Latin America (15-20 charts per site). Each chart will be retrieved and screened against 
the inclusion and exclusion criteria. The sites will be responsible for performing all data 
extraction. For eligible patients, relevant data will be extracted from the hospital medical 
records from 3-months before the date of the index hospital admission until 30-days after the 
hospital discharge date or death, whichever occurs first. All data will be entered by sites into 
electronic case report forms (eCRFs). De-identified data will be collected following the 
Health Insurance Portability and Accountability Act (HIPAA)-compliant safe harbor 
approach.34
9.5. Study Size
Given that this study is purely descriptive in nature and there is no a priori hypotheses 
specified, a formal sample size calculation is not applicable. The number of Zinforo®-treated 
patients who are eligible for the study will be determined after a site feasibility assessment is 
conducted. It is anticipated that approximately 600 eligible CAP and cSSTI patients can be 
obtained from 35-40 participating sites. 
9.6. Data Management 
Sites will enter data directly into eCRFs. Data extraction will be performed by site staff only. 
Pfizer and ICON will not have access to patient’s medical records for source data
verification.  Before beginning data collection, all sites will receive training in all study 
protocol and data collection training materials; this will include attendance at a group 
training session via teleconference. ICON staff will be available by email and teleconference 

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to review specific issues and to provide assistance after the initial instructions for completing 
the eCRF are provided to each site in the form of training documentation. 
Depending on eCRF length, the eCRF may be several sheets. Fields of entry will be, where 
possible, locked to the required data format and free text fields will be used only as necessary 
in order to collect consistent data, and to assist with data cleaning following data collection.
After the first five charts have been extracted and CRFs transmitted to ICON, the data will be 
reviewed by the ICON team to determine if any modifications or clarifications are required.
Close-out activities will be performed remotely, via telephone calls to sites.  Essential 
close-out activities include formal communications to sites, collection of any study-related 
materials from sites, and closure of study with the Institutional Review Board/Independent 
Ethics Committes (IRB/IEC).
9.6.1. Case Report Form (CRF)/Data Collection Tool (DCT)/Electronic Data Record
As used in this protocol, the term CRF should be understood to refer to either a paper form or 
an electronic data record or both, depending on the data collection method used in this study.
A CRF is required and should be completed for each included patient. 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. ICON shall ensure that the CRFs are 
securely stored at the study site in encrypted electronic form and will be password protected 
or secured in a locked room to prevent access by unauthorized third parties.
ICON 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 CRFs or source 
documents must be dated, initialed, and explained (if necessary) and should not obscure the 
original entry.
The source documents are the hospital or the physician's chart. In these cases, data collected 
on the CRFs must match those charts. 
9.6.2. Record Retention
To enable evaluations and/or inspections/audits from regulatory authorities or Pfizer, ICON
agrees to keep all study-related records, including” copies of all CRFs, and adequate 
documentation of relevant correspondence (eg, letters, meeting minutes, and telephone call 
reports).  The records should be retained by ICON according to local regulations or as 
specified in the contract whichever is longer.  ICON must ensure that the records continue to 
be stored securely for so long as they are retained.

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If ICON becomes unable for any reason to continue to retain study records for the required 
period, Pfizer should be prospectively notified.  The study records must be transferred to a 
designee acceptable to Pfizer.
Study records must be kept for a minimum of 15 years after completion or discontinuation of 
the study, unless ICON and Pfizer have expressly agreed to a different period of retention via 
a separate written agreement.  Record must be retained for longer than 15 years if required by 
applicable local regulations.  
ICON must obtain Pfizer's written permission before disposing of any records, even if 
retention requirements have been met.
9.7. Data Analysis 
The primary and secondary study outcomes will be analyzed using descriptive statistics to 
summarize patient and disease characteristics, treatment patterns, and treatment outcomes
and health care resource utilisation.  Data will be summarized by means, standard deviations, 
medians, minimums and maximums for continuous variables; and by numbers and 
percentages for categorical variables. Data will be presented in aggregate, as well as 
stratified by patient and disease characteristics of interest, such as geography and indication 
(sub-group analyses).  Missing table will be tabulated. Statistical analyses will be conducted 
using SAS. 
Detailed methodology for summary and statistical analyses of data collected in this study will 
be documented in the SAP (along with result table shells) which will be dated, filed and 
maintained by the sponsor.  The SAP may modify the plans outlined in the protocol; any 
major modifications of primary endpoint definitions or their analyses would be reflected in a 
protocol amendment.
9.8. Quality Control
ICON will be responsible for the site contact and ensuring that the data collection is 
monitored accordingly at each of the participating study sites. Designated study personnel 
will participate in a training program that will encourage consistency of process and 
procedures at the investigative site and ensure collection of high-quality data for this study. 
All sites will be trained on the protocol, study logistics, and the EDC system.  Retraining will 
be conducted as needed. 
All analyses and reporting will be carried out using anonymised data. At the time of data 
collection completion, all data will be cleaned and the final analyses will be performed by an 
experienced data analyst. Quality controls performed during statistical analyses will be 
described in the SAP.
Secure electronic archive of study data will be maintained and will include but will not be 
limited to: final raw data, analysis datasets, statistical programming performed to generate 
the results, programs and associated documentation. Access to the archive will be controlled 
and limited to authorized personnel only.  The study data will be stored and archived for an 
agreed amount of time between Pfizer and ICON in line with the ICON archive policy. 

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9.9. Limitations of the Research Methods
The target number of patients for inclusion in this study will be largely driven by feasibility, 
rather than the level of precision. It is considered feasible to include approximately 600 CAP 
and cSSTI patients since there are many sites participating in this study.  However, if this 
number is not reached after inclusion of patients, this could endanger the generalizability of 
the results. 
The data collected in this study will be retrospective data collected in routine care from the 
patient’s hospital record; there is no way to collect additional information. Therefore if the 
data was not collected at the time of administering the patient’s care it will be recorded as 
missing.  The SAP will include a section on dealing with missing data, and the proportion of 
missing data will be summarized in the clinical study report.
It is possible to miss a few patients by the inclusion criteria “patients should have had four or 
more consecutive IV doses of Zinforo”.® These criteria were created to match the inclusion 
criteria of the United States CAPTURE study. It is not likely that many patients will be 
excluded by these criteria. Zinforo® is taken twice a day, meaning that patients should take 
Zinforo® for at least two days to be included in the study. Antibiotic regimens are usually 
applied for two to three days to observe clinical response. Only after this period, a doctor 
may decide to change the antibiotic regimen.
9.10. Other Aspects
Not applicable.
10. PROTECTION OF HUMAN SUBJECTS
10.1. Patient Information 
All parties will comply with all applicable laws, including laws regarding the implementation 
of organizational and technical measures to ensure protection of patient personal data. Such 
measures will include omitting patient names or other directly identifiable data in the data 
collection form, any reports, publications, or other disclosures, except where required by 
applicable laws. 
The personal data will be stored at the study site in encrypted electronic and/or paper form 
and will be password protected or secured in a locked room to ensure that only authorized 
study staff have access.  The study site will implement appropriate technical and 
organizational measures to ensure that the personal data can be recovered in the event of 
disaster. In the event of a potential personal data breach, the study site shall be responsible 
for determining whether a personal data breach has in fact occurred and, if so, providing 
breach notifications as required by law.
To protect the rights and freedoms of natural persons with regard to the processing of 
personal data, when study data are compiled for transfer to Pfizer and other authorized 
parties, patient names will be removed and will be replaced by a single, specific, numerical 
code, based on a numbering system defined by Pfizer. All other identifiable data transferred 
to Pfizer or other authorized parties will be identified by this single, patient-specific code.  

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The investigator site will maintain a confidential list of patients who participated in the study, 
linking each patient’s numerical code to his or her actual identity.  In case of data transfer, 
Pfizer will maintain high standards of confidentiality and protection of patients’ personal data 
consistent with the clinical study agreement and applicable privacy laws.
10.2. Patient Consent
As this study does not involve data subject to privacy laws according to applicable legal 
requirements, obtaining informed consent from patients by Pfizer is not required. The 
IRB/IEC is requested to grant a waiver for having patients sign an informed consent form
(ICF) in order to include their de-identified medical data in this retrospective chart review 
study on the following grounds: 

This is a non-interventional study that only will abstract data from existing hospital 
medical records.

Requesting that patients sign an ICF is not practical because patients will no longer be 
receiving care at the hospital after discharge and some patients will have died since 
the index hospital admission.

Requesting that patients sign an ICF may introduce selection bias, which would have 
a negative impact on the representativeness of the study results.

Requesting that patients sign an ICF will cause an unnecessary inconvenience to 
patients and their families in view that no patient identifiers will be disclosed by the 
site; and hence, the study data will be fully anonymized to protect the privacy rights 
of patients (see preceding paragraph).  
Should IRBs/IECs reject the request for a waiver of consent, then the investigator will ensure 
that each study patient, or his/her legally acceptable representative, is fully informed about 
the nature and objectives of the study and possible risks associated with participation. The 
investigator, or a person designated by the investigator, will obtain written informed consent 
from each patient or the patient’s legally acceptable representative before any study-specific 
activity is performed. When the informed consent cannot be completed in person, patients or 
their legal representative will be consented remotely via telephone and will be mailed an ICF 
to sign, date, and return by mail. The investigator will retain the original of each patient's 
signed consent form. If local IRBs/IECs require consent for deceased patients, next of kin 
will be  contacted for remote informed consent as described above.
The informed consent form must be in compliance with local regulatory requirements and 
legal requirements. The informed consent form used in this study, and any changes made 
during the course of the study, must be prospectively approved by both the IRB/IEC and 
Pfizer before use.

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10.3. Patient Withdrawal
Consented patients may withdraw from the study at any time at their own request, or they 
may be withdrawn at any time at the discretion of the investigator or sponsor for safety, 
behavioral, or administrative reasons. In any circumstance, every effort should be made to 
document subject outcome, if possible. The investigator should inquire about the reason for 
withdrawal and follow-up with the subject regarding any unresolved AEs.  
If the patient withdraws from the study, and also withdraws consent for disclosure of future 
information, no further evaluations 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.
10.4. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
There must be prospective approval of the study protocol, protocol amendments, and other 
relevant documents (eg, informed consent forms if applicable) from the relevant IRBs/IECs.  
All correspondence with the IRB/IEC must be retained.  Copies of IRB/IEC approvals must 
be forwarded to Pfizer. 
10.5. Ethical Conduct of the Study
The study will be conducted in accordance with legal and regulatory requirements, as well as 
with scientific purpose, value and rigor and follow generally accepted research practices 
described in Guidelines for Good Pharmacoepidemiology Practices (GPP) issued by the 
International Society for Pharmacoepidemiology (ISPE), Good Epidemiological Practice 
(GEP) guidelines issued by the International Epidemiological Association (IEA), Good 
Practices for Outcomes Research issued by the International Society for Pharmacoeconomics 
and Outcomes Research (ISPOR), International Ethical Guidelines for Epidemiological 
Research issued by the Council for International Organizations of Medical Sciences 
(CIOMS), European Medicines Agency (EMA) European Network of Centres for 
Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological 
Standards in Pharmacoepidemiology, and FDA Guidance for Industry: Good 
Pharmacovigilance and Pharmacoepidemiologic Assessment, FDA Guidance for Industry 
and FDA Staff: Best Practices for Conducting and Reporting of Pharmacoepidemiologic 
Safety Studies Using Electronic Healthcare Data Sets, Guidance for Industry: Patient-
Reported Outcome Measures: Use in Medical Product Development to Support Labeling 
Claims and/or equivalent.
11. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS 
This study protocol requires human review of patient-level unstructured data; unstructured 
data refer to verbatim medical data, including text-based descriptions and visual depictions of
medical information, such as medical records, images of physician notes, neurological scans, 
X-rays, or narrative fields in a database.  The reviewer is obligated to report adverse events 
(AEs) with explicit attribution to any Pfizer drug that appear in the reviewed information
(defined per the patient population and study period specified in the protocol).  Explicit 
attribution is not inferred by a temporal relationship between drug administration and an AE,

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but must be based on a definite statement of causality by a healthcare provider linking drug 
administration to the AE.
The requirements for reporting safety events on the non-interventional study (NIS) adverse 
event monitoring (AEM) Report Form to Pfizer Safety are as follows:

All serious and non-serious AEs with explicit attribution to any Pfizer drug that 
appear in the reviewed information must be recorded on the CRF and reported, within 
24 hours of awareness, to Pfizer Safety using the NIS AEM Report Form.

Scenarios involving drug exposure, including exposure during pregnancy, exposure 
during breast feeding, medication error, overdose, misuse, extravasation, lack of 
efficacy, and occupational exposure associated with the use of a Pfizer product must 
be reported, within 24 hours of awareness, to Pfizer Safety using the NIS AEM 
Report Form.
For these AEs with an explicit attribution or scenarios involving exposure to a Pfizer product, 
the safety information identified in the unstructured data reviewed is captured in the Event 
Narrative section of the report form, and constitutes all clinical information known regarding 
these AEs.  No follow-up on related AEs will be conducted.
All the demographic fields on the NIS AEM Report Form may not necessarily be completed, 
as the form designates, since not all elements will be available due to privacy concerns with 
the use of secondary data sources.  While not all demographic fields will be completed, at the 
very least, at least one patient identifier (eg, gender, age as captured in the narrative field of 
the form) will be reported on the NIS AEM Report Form, thus allowing the report to be 
considered a valid one in accordance with pharmacovigilance legislation.  All identifiers will 
be limited to generalities, such as the statement “A 35-year-old female...” or “An elderly 
male...”  Other identifiers will have been removed.  
Additionally, the onset/start dates and stop dates for “Illness”, “Study Drug”, and “Drug 
Name” may be documented in month/year (mmm/yyyy) format rather than identifying the 
actual date of occurrence within the month/year of occurrence in the day/month/year 
(DD/MMM/YYYY) format.
All research staff members must complete the following Pfizer training requirements: 

“YRR Training for Vendors Working on Pfizer Studies (excluding interventional 
clinical studies and non-interventional primary data collection studies with 
sites/investigators)”. 
These trainings must be completed by research staff members prior to the start of data 
collection.  All trainings include a “Confirmation of Training Certificate” (for signature by 
the trainee) as a record of completion of the training, which must be kept in a retrievable 
format.  Copies of all signed training certificates must be provided to Pfizer. Re-training 
must be completed on an annual basis using the most current Your Reporting 
Responsibilities training materials.

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12. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS
In the event of any prohibition or restriction imposed (eg, clinical hold) by an applicable 
Competent Authority in any area of the world, or if the investigator is aware of any new 
information which might influence the evaluation of the benefits and risks of a Pfizer 
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 patients against any immediate hazard, and of 
any serious breaches of this NI study protocol that the investigator becomes aware of.
The data generated from this study will be dissemination in an appropriate peer-reviewed 
journal and/or a conference. Authorship will be based on the contribution to the study 
design, data analysis and interpretation of results in line with authorship recommendations by 
the International Committee of Medical Journal Editors (ICMJE). 

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13. REFERENCES
1.
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2.
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Tognetti L, Martinelli C, Berti S, et al. Bacterial skin and soft tissue infections: review 
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Garau J, Ostermann H, Medina J, et al. Current management of patients hospitalized 
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of clinical practice patterns and real-life effectiveness of antibiotics from the REACH 
study. Clin Microbiol Infect. 2013; 19:E377-85.
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Lipsky BA, Weigelt JA, Gupta V, Killian A and Peng MM. Skin, soft tissue, bone, and 
joint infections in hospitalized patients: epidemiology and microbiological, clinical, and 
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Talan DA, Salhi BA, Moran GJ, et al. Factors associated with decision to hospitalize 
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Martinez R, Reyes S, Lorenzo MJ and Menendez R. Impact of guidelines on outcome: 
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Woodhead M, Blasi F, Ewig S, et al. Guidelines for the management of adult lower 
respiratory tract infections. Eur Respir J. 2005; 26: 1138-80.

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13.
Personne V, Chevalier J, Buffel du Vaure C, Partouche H, Gilberg S and de 
Pouvourville G. CAPECO: Cost evaluation of community acquired pneumonia 
managed in primary care. Vaccine. 2016; 34: 2275-80.
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Rozenbaum MH, Mangen MJ, Huijts SM, van der Werf TS and Postma MJ. Incidence, 
direct costs and duration of hospitalization of patients hospitalized with community 
acquired pneumonia: A nationwide retrospective claims database analysis. Vaccine. 
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15.
Kolditz M, Tesch F, Mocke L, Hoffken G, Ewig S and Schmitt J. Burden and risk 
factors of ambulatory or hospitalized CAP: A population based cohort study. Respir 
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Schnoor M, Hedicke J, Dalhoff K, Raspe H and Schafer T. Approaches to estimate the 
population-based incidence of community acquired pneumonia. J Infect. 2007; 55: 233-
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Ramirez JA and Anzueto AR. Changing needs of community-acquired pneumonia. J
Antimicrob Chemother. 2011; 66 Suppl 3: iii3-iii9.
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Blasi F, Garau J, Medina J, et al. Current management of patients hospitalized with 
community-acquired pneumonia across Europe: outcomes from REACH. Respir Res. 
2013; 14: 44.
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Capelastegui A, Espana PP, Bilbao A, et al. Etiology of community-acquired 
pneumonia in a population-based study: link between etiology and patients 
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File TM, Jr., Low DE, Eckburg PB, et al. Integrated analysis of FOCUS 1 and FOCUS 
2: randomized, doubled-blinded, multicenter phase 3 trials of the efficacy and safety of 
ceftaroline fosamil versus ceftriaxone in patients with community-acquired pneumonia. 
Clin Infect Dis. 2010; 51: 1395-405.
21.
File TM, Jr., Low DE, Eckburg PB, et al. FOCUS 1: a randomized, double-blinded, 
multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus 
ceftriaxone in community-acquired pneumonia. J Antimicrob Chemother. 2011; 66 
Suppl 3: iii19-iii32.
22.
Low DE, File TM, Jr., Eckburg PB, et al. FOCUS 2: a randomized, double-blinded, 
multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil;versus
ceftriaxone in community-acquired pneumonia. J Antimicrob Chemother. 2011; 66 
Suppl 3: iii33-iii44.
23.
Ramani A, Udeani G, Evans J, et al. Contemporary use of ceftaroline fosamil for the 
treatment of community-acquired bacterial pneumonia: CAPTURE study experience. 
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24.
Eckberg P, Friedland D, Llorens L, L Smith, A. Witherell, G. Lauando, J. Thye, D. Day 
4 clinical response of ceftaroline for community-aquired bacterial pneumonia.
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studies and clinical safety. Clin Infect Dis. 2012; 55 Suppl 3: S173-80.
26.
Zhong NS, Sun T, Zhuo C, et al. Ceftaroline fosamil versus ceftriaxone for the 
treatment of Asian patients with community-acquired pneumonia: a randomised, 
controlled, double-blind, phase 3, non-inferiority with nested superiority trial. Lancet 
Infectious Diseases. 2015; 15: 161-71.
27.
Shorr AF, Kollef M, Eckburg PB, Llorens L and Friedland HD. Assessment of 
ceftaroline fosamil in the treatment of community-acquired bacterial pneumonia due to 
Streptococcus pneumoniae: insights from two randomized trials. Diagn Microbiol Infect 
Dis. 2013; 75: 298-303.
28.
Corey GR, Wilcox M, Talbot GH, et al. Integrated analysis of CANVAS 1 and 2: phase 
3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of 
ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure 
infection. Clin Infect Dis. 2010; 51: 641-50.
29.
Corey GR, Wilcox MH, Talbot GH, et al. CANVAS 1: the first Phase III, randomized, 
double-blind study evaluating ceftaroline fosamil for the treatment of patients with 
complicated skin and skin structure infections. J Antimicrob Chemother. 2010; 65 Suppl 
4: iv41-iv51.
30.
Wilcox MH, Corey GR, Talbot GH, et al. CANVAS 2: the second Phase III, 
randomized, double-blind study evaluating ceftaroline fosamil for the treatment of 
patients with complicated skin and skin structure infections. J Antimicrob Chemother. 
2010; 65 Suppl 4: iv53-iv65.
31.
Friedland HD, O'Neal T, Biek D, et al. CANVAS 1 and 2: analysis of clinical response 
at day 3 in two phase 3 trials of ceftaroline fosamil versus vancomycin plus aztreonam 
in the treatment of acute bacterial skin and skin structure infections. Antimicrob Agents 
Chemother. 2012; 56: 2231-6.
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controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus 
vancomycin plus aztreonam in patients with complicated skin and soft tissue infection 
with systemic inflammatory response or underlying comorbidities. J Antimicrob 
Chemother. 2016; 71: 3575-84.
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34.
De-identification of protected health information: how to anonymize PHI. HIPAA 
Journal, 2017.
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Melgaard D, Baandrup U, Bøgsted M, Bendtsen MD and Kristensen MT. Early 
mobilisation of patients with community-acquired pneumonia reduce length of 
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American adults. Postgraduate medicine. 2010; 122: 130-41.
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de Miguel-Diez J, Jimenez-Garcia R, Hernandez-Barrera V, et al. Trends in 
hospitalizations for community-acquired pneumonia in Spain: 2004 to 2013. European 
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López-de-Andrés A, de Miguel-Díez J, Jiménez-Trujillo I, et al. Hospitalisation with 
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14. LIST OF TABLES 
None.
15. LIST OF FIGURES
None.

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ANNEX 1. LIST OF STAND ALONE DOCUMENTS
None.
ANNEX 2. ENCEPP CHECKLIST FOR STUDY PROTOCOLS
Not applicable.

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ANNEX 3. ADDITIONAL INFORMATION
Community-Acquired Pneumonia(CAP) ICD-10 Codes
A48.1
Legionnaires’ disease
J13
Pneumonia due to Streptococcus pneumoniae
J14
Pneumonia due to Haemophilis influenzae
J15.0
Pneumonia due to Klebsiella pneumoniae
J15.1
Pneumonia due to Pseudomonas sp.
J15.20
Pneumonia due to Staphylococcus sp. 
unspecified
J15.21
Pneumonia due to Staphylococcus aureus
J15.3
Pneumonia due to Streptococcus  sp., group 
B
J15.4
Pneumonia due to other streptococci
J15.5
Pneumonia due to Escherichia coli
J15.6
Pneumonia due to other aerobic Gram-
negative bacteria
J15.7
Pneumonia due to Mycoplasma pneumonia
J15.8
Pneumonia due to other specified bacteria
J15.9
Unspecified bacterial pneumonia
J16.0
Chlamydial pneumonia
J16.8
Pneumonia due to other specified infectious 
organisms 
J18.0
Bronchopneumonia, unspecified organism
Z16
Infection with drug-resistant microorganisms

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Complicated Skin and Soft Tissue Infections (cSSTI) ICD-10 Codes
A46
Erysipelas
A48
Gas gangrene
E08.621-622
Diabetes mellitus due to underlying condition with other skin ulcer
E09.621-622
Drug or chemical induced DM with foot ulcer
E11.621-622
DM with foot ulcer
E13.621-622
Other specified DM with foot ulcer
H00.031–
H00.039
Abscess and furuncle of eyelid
H05.011–
H05.019
Cellulitis of orbit, abscess of orbit
H60.10–H60.13
Cellulitis of external ear
J34.0
Cellulitis and abscess of external nose
K12.2
Cellulitis and abscess of mouth
K61.0–K61.4
Abscess of anal and rectal regions
K68.11
Postprocedural retroperitoneal abscess
K68.12
Psoas muscle abscess
L00-08
Infections of the skin and subcutaneous tissue
L10-L14
Bullous disorders
L76
Intraoperative and post procedural complications of skin and 
subcutaneous tissue
L89
Pressure ulcer
L97
Non-pressure chronic ulcer of low limb
L98.4XX
Non-pressure chronic ulcer of skin
M60.0XX
Infective myositis
N48.21
Abscess of corpus cavernosum and penis
N48.22
Cellulitis of corpus cavernosum and penis
N61
Inﬂammatory disorders of breast (includes cellulitis/abscess breast)
N76.4
Abscess of vulva
M72.6
Necrotizing fasciitis
M72.9
Fibroblastic disorder, unspecified
O91.11
Abscess of breast associated with pregnancy
O91.2
Nonpurulent mastitis associated with pregnancy, the puerperium and 
lactation
S00-01
Superficial injury of head; Open wound of head
S05.X
Injury of eye and orbit
S08
Avulsion and traumatic amputation of part of head
S09
Other and unspecified injuries of head
S10-11
Superficial injury of neck; Open wound of neck
S20-21
Superficial injury of thorax; Open wound of thorax
S30-31
Superficial injury of abdomen, lower back, pelvis and external genitals; 
Open wound

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S40-41
Superficial injury of shoulder and upper arm; Open wound
S50-51
Superficial injury of elbow and forearm; Open wound
S60-61
Superficial injury of wrist, hand and fingers; Open wound
S70-71
Superficial injury of hip and thigh; Open wound
S80-81
Superficial injury of knee and lower leg; Open wound
S90-91
Superficial injury of ankle, foot and toes; Open wound
T14
Injury of unspecified body region
T30
Burn
T79
Certain early complications of trauma, not elsewhere classified
T81.3X
Disruption of wound
T81.4X
Infection following a procedure
T81.89
Other complications of procedures, not elsewhere classified
T87.4
Infection of amputation stump