drugset / Trial / NCT06633718
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a Phase 3, randomized, double-blind, multicenter, positive control study to assess the efficacy, safety, and pharmacokinetics of Meropenem and Pralurbactam compared with Ceftazidime-avibactam in combination with Metronidazole in the treatment of adult complicated intra-abdominal infections (cIAI).
Timeline
- Start
- 2024-10-31
- Primary completion
- 2027-05-30
- Completion
- 2027-05-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ceftazidime-avibactam | Other / unclassified | 2.5 g | Other |
| Subject | Meropenem | Small molecule | — | Other |
| Subject | Pralurbactam | Small molecule | — | Other |
| Comparator | Metronidazole | Small molecule | 0.915 g | Other |