Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07486024 | Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France (FAST-MDR) | PHASE3 | NOT YET_RECRUITING | 55 | — | — | Apr 1, 2026 | Feb 1, 2032 | Mar 20, 2026 | 1 | France |
Proportion of study participants achieving sustained treatment success at 18 months after study treatment start, according to 2021 WHO definitions, in the absence of permanent addition of any TB drug to the regimen or \>4 consecutive weeks treatment interruption. For the historical cohort: proportion of patients achieving treatment success (2021 WHO definitions)
| Arm | Type | Description |
|---|---|---|
| Bedaquiline - 400 mg | EXPERIMENTAL | Posology : 400 mg once daily for 2 weeks and then 200 mg thrice weekly for the remaining 22 weeks. |
| Bedaquiline - 200 mg | EXPERIMENTAL | Posology : 200 mg once daily for 8 weeks and then 100 mg daily for the remaining 16 weeks. |
| Name | Type | Description |
|---|---|---|
| Bedaquiline Oral Tablet | DRUG | Bedaquiline will be given as 400 mg once daily for 2 weeks and then 200 mg thrice weekly for the remaining 22 weeks |
Inclusion criteria 1. Is 18 years old or more 2. Is affected by bacteriologically- or molecularly-confirmed tuberculosis, due to strains of M. tuberculosis resistant to rifampicin (with or without resistance to isoniazid) according to a rapid molecular test 3. Is willing and able to give informed c...