RecruitingPhase 3NCT07486024

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

55 participants

Start Date

Sep 11, 2026

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bedaquiline Oral Tablet and a drug called Bedaquiline Oral Tablet for people with antibiotic resistance, mdr-tb, and other related conditions. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBedaquiline 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

DRUGBedaquiline Oral Tablet

Bedaquiline will be given as 200 mg once daily for 8 weeks and then 100 mg daily for the remaining 16 weeks

Locations(5)

CHU Amiens

Amiens, France

CHU Bichat - Claude-Bernard

Paris, France

Pitié-Salpêtrière Hospital - infectious and tropical diseases

Paris, France

CHU Rennes

Rennes, France

CHU Toulouse - Hôpital Purpan

Toulouse, France

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NCT07486024

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