drugset / Trial / NCT04260477
Novel Triple-dose Tuberculosis Retreatment Regimen
RandomizedParallel-groupOpen-labelTreatment
Summary
To determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent Tuberculosis (TB).
Timeline
- Start
- 2021-03-01
- Primary completion
- 2025-06
- Completion
- 2025-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ethambutol | Small molecule | 15 mg/kg | — |
| Comparator | Ethambutol | Small molecule | — | — |
| Comparator | Isoniazid | Small molecule | 5 mg/kg | — |
| Comparator | Isoniazid | Small molecule | 15 mg/kg | — |
| Comparator | Pyrazinamide | Small molecule | 25 mg/kg | — |
| Comparator | Pyrazinamide | Small molecule | — | — |
| Comparator | Rifampicin | Small molecule | 10 mg/kg | — |
| Comparator | Rifampicin | Small molecule | 30 mg/kg | — |