Trial intelligence / Profile preview

Ceftazidime-Avibactam vs BAT for Carbapenem-Resistant Infections in China

NCT04882085Phase 4

Key facts

Status: Completed
Start: Aug 2021
Primary completion: Aug 2023
Countries: 1
Sponsor: Pfizer
Modality: Irreversible Covalent Inhibitors

Drugs: ceftazidime + avibactam
Conditions: hospital-acquired pneumonia (HAP)ventilator-associated pneumonia (VAP)complicated urinary tract infection (cUTI)Intra-abdominal infection (IAI)bloodstream infection (BSI)

Overview

Phase 4, randomised, open-label trial of ceftazidime + avibactam in hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), complicated urinary tract infection (cUTI) and 4 more (2 arms), sponsored by Pfizer. Primary endpoint: Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit. Started Aug 2021; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Zavicefta Arm
Ceftazidime 2g + Avibactam 0.5g IV every 8 hours
Best Available Treatment Arm
Investigator choice (colistin, tigecycline, fosfomycin, amikacin, meropenem)

Who it enrols

Adults with confirmed carbapenem-resistant Gram-negative infections (HAP/VAP, cUTI, cIAI, BSI) requiring IV therapy, excluding those with APACHE II scores >30 or <10 or requiring prolonged treatment.

Endpoints

Primary

Percentage of Participants With Clinical Cure at Test of Cure (TOC) VisitDay 21-24

Secondary

Percentage of Participants With Clinical Cure at TOC Visit - Microbiologically Evaluable Analysis SetDay 21-24
Percentage of Participants With Clinical Cure at End of Treatment (EOT) VisitDay 14
Percentage of Participants With Favorable Per-Participant Microbiological ResponseDay 21-24
Percentage of Participants With Favorable Per-Pathogen Microbiological ResponseDay 21-24
Percentage of Participants Who Died Due to Any Cause Until Day 28Day 28
Number of Participants With Treatment-Emergent Adverse EventsDay 46
Number of Participants With Potentially Clinically Significant Post-baseline Hematology ValuesDay 24
Number of Participants With Potentially Clinically Significant Post-baseline Clinical Chemistry ValuesDay 24

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