drugset / Trial / NCT04882085

Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults

NCT04882085

Phase 4 Completed 60 enrolled Pfizer
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-08-26
Primary completion
2023-08-31
Completion
2023-08-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amikacin Small molecule
Subject Ceftazidime Small molecule 2 g Intravenous
Comparator Colistin Other / unclassified
Comparator Fosfomycin Small molecule
Comparator Meropenem Small molecule
Comparator Tigecycline Small molecule
Subject avibactam Small molecule 0.5 g Intravenous