Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France (FAST-MDR)

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.

NCT Number	NCT07486024
Lead Sponsor	Assistance Publique - Hôpitaux de Paris Collaborators: Viatris Inc.
Conditions	MDR-TB, Tuberculosis Multi Drug Resistant Active, Antibiotic Resistance, Mycobacterium Tuberculosis
Enrollment	55 participants
Start Date	2026-04
Primary Completion	2030-08 (estimated)
Study Completion	2032-02 (estimated)
Updated on ClinicalTrials.gov	2026-03-20