NCT07486024

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will be conducted in all adult patients diagnosed at the study sites with rifampicin-resistant tuberculosis. The study will assess a treatment strategy, with the regimen being adapted to the result of rapid molecular testing and phenotypic DST for fluoroquinolone resistance. Study participants will perform a rapid molecular test for fluoroquinolone resistance at screening/baseline visit: if the result is susceptible, they will receive BPaLM; if the result is resistant, they will receive a regimen with clofazimine instead of moxifloxacin (BPaLC); if the result is inconclusive, they will receive BPaLM plus clofazimine (BPaLMC). In this latter case, the regimen will be adapted according to result of phenotypic DST for fluoroquinolones: in case of susceptibility, clofazimine will be dropped (BPaLM); in case of resistance, moxifloxacin will be dropped (BPaLC).

Conditions

• MDR-TB
• Tuberculosis Multi Drug Resistant Active
• Antibiotic Resistance
• Mycobacterium Tuberculosis

Interventions

Type	Name	Description
DRUG	Bedaquiline Oral Tablet	Bedaquiline will be given as 400 mg once daily for 2 weeks and then 200 mg thrice weekly for the remaining 22 weeks
DRUG	Bedaquiline Oral Tablet	Bedaquiline will be given as 200 mg once daily for 8 weeks and then 100 mg daily for the remaining 16 weeks

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-08-01
• Completion: 2032-02-01
• First posted: 2026-03-20
• Last updated: 2026-03-20

Locations

1 site across 1 country: France