drugset / Trial / NCT04882085
Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |