drugset / Trial / NCT07486024
Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France (FAST-MDR)
Phase 3
Not yet recruiting
55 enrolled
Assistance Publique - Hôpitaux de Paris
Viatris Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The FAST-MDR trial is an externally-controlled, multicentre trial with one prospective arm, evaluating the non-inferiority of the effectiveness of BPaLM in the interventional arm versus the effectiveness of the long, conventional regimen in a French historical cohort of MDR-TB patients (2006-2022). In light of recent WHO recommendations suggesting using BPaLM as a first choice for routine MDR-TB treatment and of the expected benefits of BPaLM over the standard treatment, there will be no internal comparator arm in the study.
Timeline
- Start
- 2026-04
- Primary completion
- 2030-08
- Completion
- 2032-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 100 mg | Oral |
| Subject | Bedaquiline | Small molecule | 200 mg | Oral |