Not Yet RecruitingPhase 3

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

France55 participantsStarted 2026-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Is 18 years old or more
✓. Is affected by bacteriologically- or molecularly-confirmed tuberculosis, due to strains of M. tuberculosis resistant to rifampicin (with or without resistance to isoniazid) according to a rapid molecular test
✓. Is willing and able to give informed consent to be enrolled in the research project (signed or witnessed consent if the patient is illiterate)
✓. Patients seen in consultation or hospitalized in one of the centers involved for rifampicin-resistant TB, with screening results available and compatible within 14 days following consent signature;
✓. Is willing to use effective\* contraception: women with childbearing potential\*\* must agree to use effective contraception, unless their partner has had a vasectomy, for the duration of study treatment and up to 6 months after the end of study treatment; men who have not had a vasectomy must agree to use effective contraception for the duration of study treatment and up to 3 months after the end of study treatment;
✓. Combined hormonal contraception (oestrogen + progestin)
✓. Progestin-only hormonal contraception
✓. Intrauterine device (IUD)

Exclusion criteria

What they're measuring

Effectiveness of BPaLM compared to conventional MDR-TB regimens

Timeframe: Day 0 to Month 18

Trial details

NCT IDNCT07486024

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-08

Contact for this trial

Lorenzo GUGLIELMETTI, MD

01 40 77 97 46 lorenzo.guglielmetti@aphp.fr

View on ClinicalTrials.gov More MDR-TB trials