drugset / Trial / NCT07089186
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The study will evaluate the efficacy and safety of Meropenem and Pralurbactam versus Best Available Therapy in the treatment of Carbapenem-Resistant Enterobacteriaceae Infections. Infections evaluated in the study will be hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI), and Bloodstream Infection (BSI).
Timeline
- Start
- 2025-04-12
- Primary completion
- 2026-12
- Completion
- 2027-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amikacin | Small molecule | — | Intravenous |
| Subject | Ceftazidime-avibactam | Other / unclassified | — | Intravenous |
| Comparator | Colistin | Other / unclassified | — | Intravenous |
| Subject | Meropenem | Small molecule | — | — |
| Subject | Pralurbactam | Small molecule | — | — |
| Comparator | Tigecycline | Small molecule | — | Intravenous |