drugset / Trial / NCT05905055
P3 Study to Assess Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy for Adults With Infection Due to Carbapenem Resistant Enterobacterales
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is a multi-center, randomized, single-blind, parallel-group study to assess the efficacy and safety, when nacubactam is coadministered with cefepime or aztreonam, compared with best available therapy (BAT), in the treatment of patients with cUTI, AP, HABP, VABP, and cIAI, due to Carbapenem Resistant Enterobacterales.
Timeline
- Start
- 2023-09-22
- Primary completion
- 2025-09-01
- Completion
- 2025-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aztreonam | Small molecule | 2 g | Intravenous |
| Subject | Cefepime | Small molecule | 2 g | Intravenous |
| Subject | nacubactam | Small molecule | 1 g | Intravenous |