drugset / Trial / NCT03867136
Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of levofloxacin, linezolid, cycloserine and pyrazinamide (or clofazimine if resistant to pyrazinamide) treatments for 24 to 32 weeks (regimen consisted of clofazimine for 36\~44 weeks) in subjects with multidrug-resistant tuberculosis (MDR-TB) compared to WHO standardized shorter regimen of 36-44 weeks.
Timeline
- Start
- 2020-06-01
- Primary completion
- 2024-08-10
- Completion
- 2024-08-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amikacin | Small molecule | 600 mg | — |
| Subject | Clofazimine | Small molecule | 100 mg | — |
| Subject | Cycloserine | Small molecule | 500 mg | — |
| Subject | Cycloserine | Small molecule | 750 mg | — |
| Comparator | Ethambutol | Small molecule | 750 mg | — |
| Comparator | Ethambutol | Small molecule | 1000 mg | — |
| Comparator | Isoniazid | Small molecule | 600 mg | — |
| Subject | Levofloxacin | Small molecule | 400 mg | — |
| Subject | Levofloxacin | Small molecule | 500 mg | — |
| Subject | Levofloxacin | Small molecule | 750 mg | — |
| Subject | Linezolid | Other / unclassified | 600 mg | — |
| Comparator | Protionamide | Small molecule | 500 mg | — |
| Comparator | Protionamide | Small molecule | 750 mg | — |
| Subject | Pyrazinamide | Small molecule | 1500 mg | — |