drugset / Trial / NCT05204368
Evaluation of the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Meropenem in Hospitalized Adults With cUTI Including AP (EudraCT no. 2022-000061-40)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is A Multicenter, Randomized, Double-Blind, Double-Dummy, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/Funobactam in Comparison with Meropenem in Hospitalized Adults with Complicated Urinary Tract Infections, including Acute Pyelonephritis.
Timeline
- Start
- 2023-03-30
- Primary completion
- 2025-06
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cilastatin | Small molecule | 500 mg | Intravenous |
| Subject | IMIPENEM ANHYDROUS | Small molecule | 500 mg | Intravenous |
| Comparator | Meropenem | Small molecule | 1 g | Intravenous |
| Subject | XNW4107 | Unknown | 250 mg | Intravenous |