drugset / Trial / NCT07486024

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

NCT07486024

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

EvaluationDrugModalityDoseRoute
Subject Bedaquiline Small molecule 100 mg Oral
Subject Bedaquiline Small molecule 200 mg Oral