drugset / Trial / NCT04630145
A Study of Bedaquiline Administered as Part of a Treatment Regimen With Clarithromycin and Ethambutol in Adult Patients With Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to evaluate the efficacy of bedaquiline (BDQ) compared with rifamycin when administered as part of a treatment regimen with clarithromycin (CAM) and ethambutol (EB) in adult participants with treatment-refractory Mycobacterium avium complex-lung disease (MAC-LD) at Week 24 for microbiological assessment in mycobacteria growth indicator tube (MGIT).
Timeline
- Start
- 2021-01-08
- Primary completion
- 2024-11-06
- Completion
- 2025-11-14
Outcome
Met primary endpoint
registry analysis (superiority test); Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB) vs Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB); p =0.002 NCT04630145 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 200 mg | — |
| Comparator | Rifabutin | Small molecule | 150 mg | — |
| Comparator | Rifabutin | Small molecule | 300 mg | — |
| Comparator | Rifampicin | Small molecule | 450 mg | — |
| Comparator | Rifampicin | Small molecule | 600 mg | — |
| Background | Clarithromycin | Small molecule | 400 mg | — |
| Background | Clarithromycin | Small molecule | 500 mg | — |
| Background | Ethambutol | Small molecule | 15 mg/kg | — |
| Background | Ethambutol | Small molecule | 500 mg | — |
| Background | Ethambutol | Small molecule | 750 mg | — |
| Background | Ethambutol | Small molecule | 1 g | — |