Clinical trial NCT04198571: Retrospective Chart Review Study to Assess Characteristics, Treatment Outcomes and Resource Use of Adults Hospitalized for CAP and CSSTi Treated With Zinforo in Multiple Countries
Official 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 (REGISTERED) (Ceftaroline Fosamil) in a Usual Care Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community Acquired Pneumonia
Complicated Skin and Soft Tissue Infection
Keywords: Bacteria
Zinforo® (ceftaroline fosamil)
CAP
cSSTi
Hospitalized
Infectious Disease
Antibiotic
Cephalosporin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-12-13
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population is adult patients aged 18 years and older hospitalized for CAP or cSSTI who received intravenous (IV) Zinforo® treatment in a usual care setting in Europe and Latin America on or before 31-May-2019.

Brief summary: MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalized for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated with Zinforo® (ceftaroline fosamil) in a Usual Care Setting

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Clinical Response
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Time to Clinical Response
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants Who Achieved Clinical Cure
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Time to Clinical Cure
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants With Clinical Failure
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: CAP: Number of Participants According to Reasons for Clinical Failure
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 35 days (from the retrospective data evaluated in approximately 14 months of the study)
measure: cSSTI: Number of Participants According to Reasons for Clinical Failure
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 60 days (from the retrospective data evaluated in approximately 14 months of the study)
measure: CAP Only: Time to Clinical Stability
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 35 days (from the retrospective data evaluated in approximately 14 months of the study)
measure: CAP Only: Time to Clinical Improvement
timeFrame: Baseline (before Day 1 of Zinforo treatment) till end of Zinforo treatment, up to maximum of 35 days [from the retrospective data evaluated in approximately 14 months of the study]
measure: CAP: Number of Participants With Early Response Within 4 Days
timeFrame: Within 4 days after treatment with Zinforo (from the retrospective data evaluated in approximately 14 months of the study)
measure: cSSTI: Number of Participants With Early Response Within 3 Days
timeFrame: Within 3 days after treatment with Zinforo (from the retrospective data evaluated in approximately 14 months of the study)
measure: cSSTI Only: Time to Greater Than or Equal to (>=) 20% Reduction From Baseline in Infection Area
timeFrame: Baseline (before Day 1 of treatment) till end of treatment, up to maximum of 60 days [from the retrospective data evaluated in approximately 14 months of the study]
measure: cSSTI Only: Time to Cessation of Spread Measured by Total Infection Area
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 60 days (from the retrospective data evaluated in approximately 14 months of the study)
measure: cSSTI Only: Time to Cessation of Spread Measured by Infection Length and Width
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 60 days (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Discharge Status
timeFrame: At discharge from hospital: any day till 102 days for CAP; any day till 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants With Re-hospitalization Within 30 Days of Discharge
timeFrame: Within 30 days after discharge from hospital (discharge was any day till 102 days for CAP; any day till 162 days for cSSTI) [from the retrospective data evaluated in approximately 14 months of the study]
measure: Number of Participants According to Vital Status Within 30 Days of Discharge
timeFrame: Within 30 days after discharge from hospital (discharge was any day till 102 days for CAP; any day till 162 days for cSSTI) [from the retrospective data evaluated in approximately 14 months of the study]
measure: Number of Participants According to Minimum Inhibitory Concentration (MIC) Assessment
timeFrame: From 1 week before Zinforo treatment through 24 hours post discontinuation of Zinforo treatment during index hospitalization (102 days for CAP; 162 days for cSSTI) [from retrospective data evaluated in approximately 14 months of study]
measure: Day of MIC Assessment Since Index Hospitalization
timeFrame: From Day 1 of Index hospitalization till MIC assessment, any day till 102 days for CAP; any day till 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to MIC of Antibacterial Drugs Assessed Based on Pathogens
timeFrame: From 1 week before Zinforo treatment through 24 hours post discontinuation of Zinforo treatment during index hospitalization (102 days for CAP; 162 days for cSSTI) [from retrospective data evaluated in approximately 14 months of study]
measure: Number of Participants With Serious Adverse Events
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants With Medical Conditions Presented at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants With Hospitalization for Any Reason in the 3 Months Before the Index Hospitalization
timeFrame: 3 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants With Invasive Major Surgical Treatment in the 3 Months Before the Index Hospitalization
timeFrame: 3 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization
timeFrame: 3 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants With Radiographic Findings in Tests for CAP
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: CAP: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants With Severe CAP
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Type of Prognostic Scoring System Used to Assess CAP Severity
timeFrame: At index hospitalization admission(from the retrospective data evaluated in approximately 14 months of the study)
measure: Time of CAP Diagnosis at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants With Recurrent CAP Infections at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: CAP: Number of Participants With Polymerase Chain Reaction (PCR) Determination of H1N1 Influenza Virus at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: CAP: Number of Participants According to Influenza Vaccination Status During 12 Months Prior to Index Hospitalization
timeFrame: 12 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)
measure: CAP: Number of Participants According to Pneumococcal Vaccination Status at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: CAP: Number of Participants According to the Biomarkers Used for Monitoring Clinical Evolution at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: cSSTI: Number of Participants According to Area of Extension of Skin Infection at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: cSSTI: Number of Participants According to Level of Infections at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: Time of cSSTI Diagnosis at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: cSSTI: Number of Participants With Recurrent Infection at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Systemic Signs of cSSTI at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization
timeFrame: At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization
timeFrame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization
timeFrame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization
timeFrame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Duration of Pre-Zinforo Treatment During Index Hospitalization
timeFrame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Time From Symptom Onset to First Dose of Pre-Zinforo Treatment
timeFrame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Types of Pre-Zinforo Treatment During Index Hospitalization
timeFrame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Doses Administered for Pre-Zinforo Treatment During Index Hopsitalization
timeFrame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants With Pre-Zinforo Treatment Modification During Index Hospitalization
timeFrame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Reasons for Pre-Zinforo Treatment Modification
timeFrame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index Hospitalization
timeFrame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Time to Treatment Modification From Initial Dose of Pre-Zinforo Treatment
timeFrame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants With Insufficient Response to Pre-Zinforo Treatment During Index Hospitalization
timeFrame: Before Zinforo treatment initiation during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Duration of Zinforo Treatment During Index Hospitalization
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Time From Admission to First Dose of Zinforo During Index Hospitalization
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Time From Symptom Onset to First Dose of Zinforo During Index Hospitalization
timeFrame: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Types of Treatment for Zinforo
timeFrame: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Daily Dose of Zinforo
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Infusions Administered Daily for Zinforo
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Locations of Zinforo Administration
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants Administered Zinforo as Monotherapy or Combination Therapy
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants Receiving Concomitant Therapies Along With Zinforo
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment
timeFrame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Lines of Therapy for Post-Zinforo Treatment
timeFrame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Route of Administration for Post-Zinforo Treatment
timeFrame: CAP (up to maximum of 102 days), cSSTI (up to maximum of 162 days)
measure: Duration From Zinforo Discontinuation to Initiation of New Treatment
timeFrame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Doses Administered for Post Zinforo Treatment
timeFrame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Reasons for Switching to Post-Zinforo Treatment
timeFrame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants Based on Treatment Response to Post-Zinforo Treatment
timeFrame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participant According to Type of Location for Post-Zinforo Treatment Administration
timeFrame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants Who Achieved Clinical Response to Post-Zinforo Treatment
timeFrame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment
timeFrame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Duration of Index Hospitalization
timeFrame: Day 1 of admission of index hospitalization to discharge from hospital (from the retrospective data evaluated in approximately 14 months of the study)
measure: Duration in Intensive Care Unit
timeFrame: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants Who Received Renal Replacement Therapy Post Initiating Treatment With Zinforo
timeFrame: Post initiation of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Treatments Received During Index Hospitalization
timeFrame: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants Who Received Home-Based Care Through a Healthcare Agency
timeFrame: Within 30 days post discharge from index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants With Re-hospitalizations
timeFrame: Within 30 days post discharge from index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)
measure: Duration of Re-hospitalizations
timeFrame: Day 1 of re-hospitalization till discharge (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants According to Reasons for Re-hozpitalization
timeFrame: Day 1 of re-hospitalization till discharge (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants With Development of Sepsis During Index Hospitalization
timeFrame: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants With Quick Sepsis-Related Organ Failure Assessment (qSOFA) Conducted
timeFrame: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants Requiring Isolation
timeFrame: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral Nutrition
timeFrame: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Number of Participants Who Suffered Acute Renal Failure Necessitating Renal Replacement
timeFrame: During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Total Number of Doses of Zinforo Administered
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Total Number of Doses of Other Antibiotics Administered in Combination With Zinforo
timeFrame: Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Total Dose of Other Antibiotics Administered Post Zinforo Treatment
timeFrame: Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
measure: Cost of Hospitalization
timeFrame: Day 1 of index hospitalization till discharge, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Real Hospital Português de Beneficência
state: PE
city: Recife
country: Brazil
facility: Hospital Esperança
city: Medellin
country: Colombia
facility: Clínica Las Américas
state: Antioquia
city: Pereira
country: Colombia
facility: E.S.E. Hospital Universitario San Jorge de Pereira
state: Risaralda
city: Cali
country: Colombia
facility: Fundación Valle del Lili
state: Valle DEL Cauca
city: Cali
country: Colombia
facility: Centro médico Imbanaco
city: Dijon
country: France
facility: CHU Francois Mitterrand
city: Grenoble
country: France
facility: CHU de Grenoble Alpes
city: Lyon
country: France
facility: Croix-Rousse hospital, Hospices Civils de Lyon
city: Nantes
country: France
facility: CHU Nantes
city: Athens
country: Greece
facility: Attikon University General Hospital
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
city: Larissa
country: Greece
facility: General University Hospital of Larissa
city: Patras
country: Greece
facility: Patras University Medical School
city: Thessaloniki
country: Greece
facility: AHEPA General University Hospital of Thessaloniki
city: Brescia
country: Italy
facility: Asst Spedali Civili Brescia and Universita Degli Studi di Brescia
state: Other
city: Napoli
country: Italy
facility: AORN Ospedali dei Colli - Ospedale Monaldi
state: Other
city: Napoli
country: Italy
facility: Azienda Ospedaliera Dei Colli
city: Turin
country: Italy
facility: Aou Citta Della Salute E Della Scienza Scdu Malattie Infettive 2
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), Presidio Ospedaliero Universitario Santa
city: Ufa
country: Russian Federation
facility: Republican Clinical Hospital named after G.G. Kuvatova
state: Republic OF Bashkortostan
city: Izhevsk
country: Russian Federation
facility: BUZ UR First Republican Clinical Hospital under the Ministry of Healthcare of Udmurt Republic UR
state: Udmurtia
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Barcelona
country: Spain
facility: Hospital Universitario Valle de Hebrón
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: