drugset / Trial / NCT05306223
A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate efficacy and safety of an oral bedaquiline-containing multidrug-resistant tuberculosis (MDR-TB) short-course regimen (SCR) compared to an oral SCR not including bedaquiline at the end of treatment in participants with pulmonary MDR-TB in China.
Timeline
- Start
- 2022-05-10
- Primary completion
- 2025-08-08
- Completion
- 2025-08-08
Publications
- Gao J, Huang Z, Ren F, Wu Y, Wang H, Wu G, Du J, Yan X, Pei Y, Jin L, Xiong Y, Shi L, Cui J, Chen X, Li X, Sha W, An H, Callewaert K, Lounis N, Bakare N, Jiang Y, Zhang R, Wang L, Gao M, Li L. Evaluation of an oral bedaquiline regimen for treating multidrug-resistant TB in China: a randomized trial. Infection. 2026 Jun;54(3):1265-1277. doi: 10.1007/s15010-026-02734-w. Epub 2026 Apr 2.
- Gao J, Gao M, Du J, Pang Y, Mao G, Lounis N, Bakare N, Jiang Y, Zhan Y, Liu Y, Li L; Trial Team. A pragmatic randomized controlled trial to evaluate the efficacy and safety of an oral short-course regimen including bedaquiline for the treatment of patients with multidrug-resistant tuberculosis in China: study protocol for PROSPECT. Trials. 2024 Apr 1;25(1):227. doi: 10.1186/s13063-024-07946-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 200 mg | Oral |
| Background | Clofazimine | Small molecule | 100 mg | Oral |
| Background | Cycloserine | Small molecule | 750 mg | Oral |
| Background | Levofloxacin | Small molecule | 1000 mg | Oral |
| Background | Linezolid | Other / unclassified | 600 mg | Oral |
| Background | Protionamide | Small molecule | 800 mg | Oral |
| Background | Pyrazinamide | Small molecule | 2000 mg | Oral |