drugset / Trial / NCT04629378
Evaluating the EBA of Meropenem With Amoxicillin/Clavulanate and Pyrazinamide or Bedaquiline in Adults With PTB
RandomizedParallel-groupOpen-labelTreatment
Summary
A single-center, open-label clinical trial to determine the early bactericidal activity (EBA) and safety of the combination of meropenem and amoxicillin/clavulanate plus pyrazinamide vs. meropenem and amoxicillin/clavulanate plus bedaquiline administered for 14 consecutive days. This study forms part of a series of 2-week EBA studies to determine the relative bactericidal activity of several new or repurposed anti-tuberculosis agents from which to determine the most effective and safe combination to evaluate in larger and longer duration regimen-based trials.
Timeline
- Start
- 2020-08-17
- Primary completion
- 2021-06-04
- Completion
- 2021-06-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 62.5 mg | — |
| Subject | Amoxicillin | Other / unclassified | 1000 mg | — |
| Subject | Bedaquiline | Small molecule | 400 mg | Oral |
| Subject | Meropenem | Small molecule | 6 g | Intravenous |
| Subject | Pyrazinamide | Small molecule | 20 mg/kg | Oral |
| Subject | Pyrazinamide | Small molecule | 30 mg/kg | Oral |
| Comparator | Rifafour | Unknown | — | Oral |