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

Study acronym: FAST-MDR
StatusRecruiting
PhasePhase 3
Started2026-09-11
View on ClinicalTrials.gov ↗

Amendment history

2026-09-17
notable
Recruitment opened
Trial sites expanded: 1 → 5 locations
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.
Trial Details
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 2026-09-11
Primary Completion 2030-08 (estimated)
Study Completion 2032-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-16