drugset / Trial / NCT04717908
Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)-PLUS
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of bedaquiline, linezolid, cycloserine, clofazimine and pyrazinamide treatments guided by PZA sensitivity for 24 to 36 weeks in subjects with fluoroquinolone-resistant MDR-TB .
Timeline
- Start
- 2021-01-20
- Primary completion
- 2024-06-22
- Completion
- 2024-06-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 200 mg | Oral |
| Subject | Clofazimine | Small molecule | 100 mg | Oral |
| Subject | Cycloserine | Small molecule | 500 mg | Oral |
| Subject | Cycloserine | Small molecule | 750 mg | Oral |
| Subject | Linezolid | Other / unclassified | 600 mg | Oral |
| Subject | Pyrazinamide | Small molecule | 1500 mg | Oral |