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.
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 unable to take oral drugs
Has known allergies, hypersensitivity or intolerance or any other medical condition and contra indications to any drug of the regimen
Unwilling to comply to study procedures, at the clinician appreciation
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
Parallel
Bedaquiline Oral Tablet
DrugBedaquiline will be given as 400 mg once daily for 2 weeks and then 200 mg thrice weekly for the remaining 22 weeks
Bedaquiline Oral Tablet
DrugBedaquiline will be given as 200 mg once daily for 8 weeks and then 100 mg daily for the remaining 16 weeks
Effectiveness of BPaLM compared to conventional MDR-TB regimens
Proportion of study participants achieving sustained treatment success at 18 months after study treatment start, according to 2021 WHO definitions, in the absence of permanent addition of any TB drug to the regimen or \>4 consecutive weeks treatment interruption. For the historical cohort: proportion of patients achieving treatment success (2021 WHO definitions)
Early markers of BPaLM effectiveness (proportion of participants)
Proportion of participants with a negative sputum culture at two months after study treatment start
Early markers of BPaLM effectiveness (time to sputum culture conversion)
Time to sputum culture conversion (defined as time between treatment start and the first of two consecutive negative sputum cultures, from specimens taken at least 7 days apart, as per WHO definitions)
BPaLM non-inferior effectiveness
For BPaLM arm, treatment success at 6 months, without addition of any TB drug or \>4 consecutive weeks treatment interruption; For historical cohort: treatment success \[all according to 2021 WHO definitions\]
BPaLM non-inferior effectiveness
For BPaLM arm, sustained treatment success at 12 months, without addition of any TB drug or \>4 consecutive weeks treatment interruption; For historical cohort: treatment success \[all according to 2021 WHO definitions\]
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
Viatris Inc.
Collaborator
