CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Zavicefta, Ceftazidime-Avibactam +1 moredrug
Likely dose
Zavicefta, Ceftazidime-Avibactam 2.5 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04882085
NCT04882085Phase 4Completed
CompareCT.gov

AN OPEN-LABEL, RANDOMIZED, MULTI-CENTER, ACTIVE-CONTROLLED STUDY TO ESTIMATE THE EFFICACY AND SAFETY OF CEFTAZIDIME-AVIBACTAM (CAZ-AVI) VERSUS BEST AVAILABLE TREATMENT (BAT) IN THE TREATMENT OF INFECTIONS DUE TO CARBAPENEM-RESISTANT GRAM-NEGATIVE PATHOGENS IN CHINESE ADULTS

Pfizer·interventional·Posted May 11, 2021·Updated Oct 21, 2024

In Brief

A Phase 4 clinical trial evaluating Zavicefta, Ceftazidime-Avibactam and Best Available Treatment for Urinary Tract Infection and 5 related conditions. Completed, enrolled 60 participants across 37 sites.

Detailed Summary

This is an open-label, randomized, multi-center, interventional, active-controlled Phase 4 study to evaluate the efficacy and safety of CAZ-AVI versus BAT in the treatment of infected participants with selected infection types (Hospital Acquired Pneumonia \[HAP\] (including Ventilator-Associated Pneumonia \[VAP\]); Complicated Urinary-Tract Infection \[cUTI\]; Complicated Intra-Abdominal Infection \[cIAI\]; Bloodstream Infection \[BSI\]) due to carbapenem-resistant Gram-negative pathogens in China.This study will be an estimation study. The statistical inference will be based on point estimate and confidence interval.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Tract Infection, Acute Pyelonephritis, Hospital Acquired Pneumonia, Ventilator-associated Pneumonia, Bacteremia, Intra-abdominal Infection
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedMay 11, 2021
Enrollment StartAug 26, 2021
Primary CompletionAug 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.1 years ago

Interventions

Zavicefta, Ceftazidime-Avibactamdrug

CAZ-AVI 2.5 g (2 g ceftazidime + 0.5 g avibactam) administered IV as a 2 hour infusion every 8 hours. Dose adjustments are available for participants with CrCL ≤50 mL/min.

Best Available Treatmentdrug

main treatment expected to be used as either monotherapy or in combination are colistin, tigecycline, fosfomycin, amikacin, and meropenem