A SINGLE ARM, OPEN-LABEL, MULTI-CENTER, INTERVENTIONAL STUDY EVALUATING THE EFFICACY AND SAFETY OF CEFTAZIDIME-AVIBACTAM (CAZ-AVI) IN CHINESE ADULTS WITH HAP (INCLUDING VAP)

Pfizer53 sites in 1 country235 target enrollmentMay 21, 2021

ConditionsHospital-Acquired Pneumonia

InterventionsZavicefta, Ceftazidime-Avibactam

DrugsZavicefta, Ceftazidime-Avibactam

Overview

Phase: Phase 4
Intervention: Zavicefta, Ceftazidime-Avibactam
Conditions: Hospital-Acquired Pneumonia
Sponsor: Pfizer
Enrollment: 235
Locations: 53
Primary Endpoint: Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: Clinical Modified Intent-to-Treat (cMITT) Population
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, single arm, open-label, multi-center clinical study evaluating the effectiveness and safety of CAZ-AVI in participants with HAP (including VAP), who have initiated treatment with CAZ-AVI in an inpatient hospital setting. The duration of antibiotic treatment with the CAZ-AVI is 7-14 days. Participants must receive intravenously (IV) CAZ-AVI in the hospital for at least 7 full days. There are no formal hypothesis tests planned for this study. The number and percent of participants having clinical cure, failure, and indeterminate at TOC visit in the cMITT analysis population will be summarized.

Registry

clinicaltrials.gov

Start Date

May 21, 2021

End Date

May 4, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female participants ≥18 and ≤90 years of age.
•Onset of symptoms ≥48 hours after admission or \<7 days after discharge from an inpatient acute or chronic care facility.
•New or worsening infiltrate on chest X-ray obtained within 48 hours prior to screening.
•Participants have systemic signs and respiratory signs or symptoms of HAP/VAP

Exclusion Criteria

•Other medical or psychiatric condition may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
•Participant is expected to require a treatment course for HAP longer than 14 days.
•The total duration of antibiotic exposure for antibiotics whose administration begins in the 48 hours is longer than 24 hours.
•Previous administration with an investigational drug within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
•Acute Physiology and Chronic Health Evaluation (APACHE) II score \>30 or \<10 using the most recent available data.

Arms & Interventions

CAZ-AVI

Intervention: Zavicefta, Ceftazidime-Avibactam

Outcomes

Primary Outcomes

Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: Clinical Modified Intent-to-Treat (cMITT) Population

Time Frame: TOC visit: any day from Day 21 to 25

Clinical cure: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at end of treatment (EOT), and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive. Gram negative is abbreviated as gram -ve and gram positive as gram +ve.

Secondary Outcomes

Percentage of Participants With Clinical Cure at EOT Visit: cMITT Population(EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days))
Percentage of Participants With Clinical Cure at EOT and TOC Visit: Microbiological Modified Intent-to-Treat (mMITT) Population(EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25)
Percentage of Participants With Favorable Per-Participant Microbiological Response at the EOT and TOC Visits: mMITT Population(EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25)
Percentage of Participants With Favorable Per-Pathogen Microbiological Response at the EOT and TOC Visits: mMITT Population(EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25)
Percentage of Participants With Clinical Cure at the EOT and TOC Visits in Participants With Gram-negative Baseline Pathogens Resistant to Ceftazidime: mMITT Population(EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25)
Percentage of Participants With Favorable Per-Participant Microbiologic Response at the EOT and TOC Visits in Participants With Gram-negative Baseline Pathogens Resistant to Ceftazidime: mMITT Population(EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25)
Percentage of Participants With Death Due to Any Cause at the TOC Visit and at Day 28 Visit: cMITT Population(TOC visit: any day from Day 21 to 25; Day 28)
Percentage of Participants With Death Due to Any Cause at the TOC Visit and at Day 28 Visit: mMITT Population(TOC visit: any day from Day 21 to 25; Day 28)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days))
Number of Participants With Clinically Significant Post-Baseline Laboratory Test Abnormalities(Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days))
Number of Participants With Vital Signs Data According to Pre-defined Criteria(Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days))