Optic

ID

NCT04198571

Name

C2661041

Description

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

Trial arms

Trial start

2020-05-17

Estimated PCD

2021-07-23

Trial end

2021-08-30

Status

Completed

Treatment

Zinforo (ceftaroline fosamil)

IV Solution

Arms:

Zinforo Treated

Other names:

Teflaro

Size

317

Primary endpoint

Number of Participants With Clinical Response

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)

Time to Clinical Response

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)

Number of Participants Who Achieved Clinical Cure

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)

Time to Clinical Cure

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)

Number of Participants With Clinical Failure

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)

CAP: Number of Participants According to Reasons for Clinical Failure

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)

cSSTI: Number of Participants According to Reasons for Clinical Failure

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)

CAP Only: Time to Clinical Stability

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)

CAP Only: Time to Clinical Improvement

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]

CAP: Number of Participants With Early Response Within 4 Days

Within 4 days after treatment with Zinforo (from the retrospective data evaluated in approximately 14 months of the study)

cSSTI: Number of Participants With Early Response Within 3 Days

Within 3 days after treatment with Zinforo (from the retrospective data evaluated in approximately 14 months of the study)

cSSTI Only: Time to Greater Than or Equal to (>=) 20% Reduction From Baseline in Infection Area

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]

cSSTI Only: Time to Cessation of Spread Measured by Total Infection Area

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)

cSSTI Only: Time to Cessation of Spread Measured by Infection Length and Width

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)

Number of Participants According to Discharge Status

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)

Number of Participants With Re-hospitalization Within 30 Days of Discharge

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]

Number of Participants According to Vital Status Within 30 Days of Discharge

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]

Number of Participants According to Minimum Inhibitory Concentration (MIC) Assessment

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]

Day of MIC Assessment Since Index Hospitalization

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)

Number of Participants According to MIC of Antibacterial Drugs Assessed Based on Pathogens

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]

Number of Participants With Serious Adverse Events

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)

Number of Participants With Medical Conditions Presented at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

Number of Participants With Hospitalization for Any Reason in the 3 Months Before the Index Hospitalization

3 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)

Number of Participants With Invasive Major Surgical Treatment in the 3 Months Before the Index Hospitalization

3 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)

Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization

3 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)

Number of Participants With Radiographic Findings in Tests for CAP

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

CAP: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

Number of Participants With Severe CAP

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

Number of Participants According to Type of Prognostic Scoring System Used to Assess CAP Severity

At index hospitalization admission(from the retrospective data evaluated in approximately 14 months of the study)

Time of CAP Diagnosis at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

Number of Participants With Recurrent CAP Infections at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

CAP: Number of Participants With Polymerase Chain Reaction (PCR) Determination of H1N1 Influenza Virus at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

CAP: Number of Participants According to Influenza Vaccination Status During 12 Months Prior to Index Hospitalization

12 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)

CAP: Number of Participants According to Pneumococcal Vaccination Status at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

CAP: Number of Participants According to the Biomarkers Used for Monitoring Clinical Evolution at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

cSSTI: Number of Participants According to Area of Extension of Skin Infection at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

cSSTI: Number of Participants According to Level of Infections at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

Time of cSSTI Diagnosis at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

cSSTI: Number of Participants With Recurrent Infection at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

Number of Participants According to Systemic Signs of cSSTI at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization

At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)

Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization

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)

Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization

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)

Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization

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)

Duration of Pre-Zinforo Treatment During Index Hospitalization

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)

Time From Symptom Onset to First Dose of Pre-Zinforo Treatment

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)

Number of Participants According to Types of Pre-Zinforo Treatment During Index Hospitalization

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)

Number of Doses Administered for Pre-Zinforo Treatment During Index Hopsitalization

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)

Number of Participants With Pre-Zinforo Treatment Modification During Index Hospitalization

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)

Number of Participants According to Reasons for Pre-Zinforo Treatment Modification

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)

Number of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index Hospitalization

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)

Time to Treatment Modification From Initial Dose of Pre-Zinforo Treatment

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)

Number of Participants With Insufficient Response to Pre-Zinforo Treatment During Index Hospitalization

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)

Duration of Zinforo Treatment During Index Hospitalization

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)

Time From Admission to First Dose of Zinforo During Index Hospitalization

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)

Time From Symptom Onset to First Dose of Zinforo During Index Hospitalization

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)

Number of Participants According to Types of Treatment for Zinforo

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)

Daily Dose of Zinforo

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)

Number of Infusions Administered Daily for Zinforo

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)

Number of Participants According to Locations of Zinforo Administration

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)

Number of Participants Administered Zinforo as Monotherapy or Combination Therapy

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)

Number of Participants Receiving Concomitant Therapies Along With Zinforo

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)

Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment

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)

Number of Participants According to Lines of Therapy for Post-Zinforo Treatment

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)

Number of Participants According to Route of Administration for Post-Zinforo Treatment

CAP (up to maximum of 102 days), cSSTI (up to maximum of 162 days)

Duration From Zinforo Discontinuation to Initiation of New Treatment

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)

Number of Doses Administered for Post Zinforo Treatment

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)

Number of Participants According to Reasons for Switching to Post-Zinforo Treatment

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)

Number of Participants Based on Treatment Response to Post-Zinforo Treatment

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)

Number of Participant According to Type of Location for Post-Zinforo Treatment Administration

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)

Number of Participants Who Achieved Clinical Response to Post-Zinforo Treatment

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)

Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment

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)

Duration of Index Hospitalization

Day 1 of admission of index hospitalization to discharge from hospital (from the retrospective data evaluated in approximately 14 months of the study)

Duration in Intensive Care Unit

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)

Number of Participants Who Received Renal Replacement Therapy Post Initiating Treatment With Zinforo

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)

Number of Participants According to Treatments Received During Index Hospitalization

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)

Number of Participants Who Received Home-Based Care Through a Healthcare Agency

Within 30 days post discharge from index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)

Number of Participants With Re-hospitalizations

Within 30 days post discharge from index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)

Duration of Re-hospitalizations

Day 1 of re-hospitalization till discharge (from the retrospective data evaluated in approximately 14 months of the study)

Number of Participants According to Reasons for Re-hozpitalization

Day 1 of re-hospitalization till discharge (from the retrospective data evaluated in approximately 14 months of the study)

Number of Participants With Development of Sepsis During Index Hospitalization

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)

Number of Participants With Quick Sepsis-Related Organ Failure Assessment (qSOFA) Conducted

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)

Number of Participants Requiring Isolation

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)

Number of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral Nutrition

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)

Number of Participants Who Suffered Acute Renal Failure Necessitating Renal Replacement

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)

Total Number of Doses of Zinforo Administered

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)

Total Number of Doses of Other Antibiotics Administered in Combination With Zinforo

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)

Total Dose of Other Antibiotics Administered Post Zinforo Treatment

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)

Cost of Hospitalization

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)

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.

Protocol

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Updated at

2024-03-26

Organization

Pfizer

Product

Zinforo

Indication

Community Acquired Pneumonia

Indication

Skin and Soft Tissue Infection