drugset / Trial / NCT05204563
Imipenem/Cilastatin-XNW4107 Versus Imipenem/Cilastatin/Relebactam for Treatment of Participants With Bacterial Pneumonia (XNW4107-302, REITAB-2)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study aims to compare treatment with Imipenem/Cilastatin-XNW4107 (IMI-XNW4107) with imipenem/cilastatin/relebactam (IMI/REL) in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VAPB, respectively). The primary hypothesis is that IMI-XNW4107 is non-inferior to IMI/REL in all-cause mortality.
Timeline
- Start
- 2022-07-31
- Primary completion
- 2024-09-29
- Completion
- 2024-09-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cilastatin | Small molecule | 500 mg | Intravenous |
| Subject | IMIPENEM ANHYDROUS | Small molecule | 500 mg | Intravenous |
| Comparator | Relebactam | Small molecule | — | — |
| Subject | XNW4107 | Unknown | 250 mg | Intravenous |