Authorised Therapeutic confirmatory (Phase III) Patients diagnosed at the study sites with rifampicinresistant tuberculosis during the recruitment period will be evaluated for study inclusion.

Feasibility of the Application of a new Six-month Treatment for multidrug-resistant tuberculosis (MDR-TB) patients in France (FAST-MDR)

EU CTIS ID: 2024-512763-32-00

What this study is testing

Determine if BPaLM has non-inferior effectiveness at 18 months after study treatment start compared to the long, conventional MDR-TB regimens assessed in an historical cohort of patients treated in France in 2006-2022.

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1) Is 18 years old or more
2) 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
3) Is willing and able to give informed consent to be enrolled in the research project (signed or witnessed consent if the patient is illiterate)
4) 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;
5) Is affiliated to a social security system (as beneficiary) or has state medical aid (AME) or has an ongoing demand for AME or has an ongoing demand for an emergency medical care (dispositif de soins d'urgence, as applicable for tuberculosis)

You likely can't join if

1) Is unable to take oral drugs
10) Has significant and uncorrectable lab abnormalities at baseline: haemoglobin ≤7.9 g/dL, platelet count <75 000/mm3; absolute neutrophil count <1 000/ mm3; potassium <3.0 mEq/L; serum creatinine >3 x upper level of normality (ULN); alanine aminotransferase (ALT) ≥3 x ULN
11) Has peripheral neuropathy of grade 3 or 4 (CTCAE scale)
12) Has any other condition (social or medical) which, in the opinion of the site investigator, would make the study participant unsafe
13) Is known to be pregnant or is unwilling or unable to stop breastfeeding an infant
2) Has known allergies, hypersensitivity or intolerance or any other medical condition and contra indications to any drug of the regimen

See the full eligibility criteria

Who can join

1) Is 18 years old or more
2) 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
3) Is willing and able to give informed consent to be enrolled in the research project (signed or witnessed consent if the patient is illiterate)
4) 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;
5) Is affiliated to a social security system (as beneficiary) or has state medical aid (AME) or has an ongoing demand for AME or has an ongoing demand for an emergency medical care (dispositif de soins d'urgence, as applicable for tuberculosis)

What rules you out

1) Is unable to take oral drugs
10) Has significant and uncorrectable lab abnormalities at baseline: haemoglobin ≤7.9 g/dL, platelet count <75 000/mm3; absolute neutrophil count <1 000/ mm3; potassium <3.0 mEq/L; serum creatinine >3 x upper level of normality (ULN); alanine aminotransferase (ALT) ≥3 x ULN
11) Has peripheral neuropathy of grade 3 or 4 (CTCAE scale)
12) Has any other condition (social or medical) which, in the opinion of the site investigator, would make the study participant unsafe
13) Is known to be pregnant or is unwilling or unable to stop breastfeeding an infant
2) Has known allergies, hypersensitivity or intolerance or any other medical condition and contra indications to any drug of the regimen
3) Unwilling to comply to study procedures, at the clinician appreciation
4) Has proven or likely resistance to bedaquiline, clofazimine, linezolid, pretomanid or moxifloxacine, or has had exposure (for 30 days or more) in past five years to bedaquiline, clofazimine, delamanid, linezolid, or pretomanid
5) Is taking or needs to take contraindicated medications in association with investigational medicinal products
6) Has ≥500 msec QTcF interval on any ECG taken at screening or baseline visits, or has any cardiac risk factor for severe arrhythmia
7) Has severe extrapulmonary TB, including meningo-encephalitis, brain abscess, osteo-arthritis, osteomyelitis
8) Is concurrently participating in another trial of any medicinal product
9) Is already on a MDR/RR-TB treatment regimen since 4 weeks or more, and has no need to change the treatment regimen (i.e. adverse events, treatment failure)

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.