A Phase 3 interventional study of Bedaquiline Oral Tablet and Bedaquiline Oral Tablet in MDR-TB, Tuberculosis Multi Drug Resistant Active and Antibiotic Resistance, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
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).
124 studies on the registry are indexed under Tuberculosis, Multidrug-Resistant; 25 are open to participants now.
This study's planned enrollment of 55 is below the median of 150 across 81 interventional studies indexed under Tuberculosis, Multidrug-Resistant.
Browse Tuberculosis, Multidrug-Resistant studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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;
The following contraception methods are considered effective, according to local regulation (CTFG recommendations, March 2024):
Vasectomised partner
Exclusion criteria :
Posology : 400 mg once daily for 2 weeks and then 200 mg thrice weekly for the remaining 22 weeks.
Drug: Bedaquiline Oral Tablet
Posology : 200 mg once daily for 8 weeks and then 100 mg daily for the remaining 16 weeks.
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
Bedaquiline 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)
Time frame: Day 0 to Month 18
Early markers of BPaLM effectiveness (proportion of participants)
Proportion of participants with a negative sputum culture at two months after study treatment start
Time frame: Day 0 to Day 60
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)
Time frame: Day 0 to month 18
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 \[all according to 2021 WHO definitions\]
Time frame: Start to month 6
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 \[all according to 2021 WHO definitions\]
Time frame: Start to month 12
Rate of post-treatment relapse
For BPaLM arm, proportion of participants with TB relapse at 12 months after study treatment start. For historical cohort: proportion of patients with TB relapse according to latest available post-treatment follow-up data
Time frame: Start to month 12
Rate of post-treatment relapse
For BPaLM arm, proportion of participants with TB relapse at 18 months after study treatment start. For historical cohort: proportion of patients with TB relapse according to latest available post-treatment follow-up data
Time frame: Start to month 18
Factors associated with effectiveness of BPaLM at 18 month (interventional group only)
Factors associated with effectiveness of BPaLM at 18 months after study treatment start defined as patient characteristics, extension of TB disease, previous TB treatment, resistance profile and lineage of the TB strain, treatment adherence, and adverse events.
Time frame: Start to month 18
Safety of BPaLM regimen
Proportion of participants with any serious adverse event \[US FDA definition\] or any Grade 3 or higher adverse event \[CTCAE Severity Scale v 5.0\]
Time frame: Start to month 18
Pharmacology effectiveness (pharmacokinetic analyses)
Defined as population pharmacokinetic analyses for each drug
Time frame: Start to month 6
Pharmacology effectiveness (evolution of MICs according to strain lineage)
Defined as multivariate models adjusting for MICs, strain lineage and patient factors to identify TDM measures associated, for each drug, with effectiveness, safety, and drug resistance acquisition
Time frame: Start to month 6
Pharmacology effectiveness (evolution of MICs according to patient characteristics)
Defined as multivariate models adjusting for patient characteristics and extension of TB disease
Time frame: Start to month 6
Rate of acquisition of drug resistance at 12 months (experimental group only)
Defined as the proportion of participants who acquired drug resistance to any of the study regimen drugs.
Time frame: Start to month 12
Rate of acquisition of drug resistance at 18 months (each groups)
Defined as the proportion of participants who acquired drug resistance to any of the study regimen drugs.
Time frame: Start to month 18
Microbiology eligibility - diagnostic delay (interventional group only)
Defined as time between screening and microbiological eligibilty assessment
Time frame: Start to Month 1
Microbiology eligibility - diagnostic accuracy (interventional group only)
Defined as diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of different genotypic tests
Time frame: Start to Month 1
Treatment adherence (interventional group only)
Proportion of doses taken out of total expected doses
Time frame: Start to month 6
Health-related quality of life at treatment start (interventional group only)
Measured by Saint George's Respiratory questionnaire at treatment start
Time frame: Start to month 1
Health-related quality of life at 6 months (interventional group only)
Measured by Saint George's Respiratory questionnaire at 6 months
Time frame: Start to month 6
Health-related quality of life at 12 months (interventional group only)
Measured by Saint George's Respiratory questionnaire at 12 months
Time frame: Start to month 12
Satisfaction of study participants
Measured by Likert scales at 12 months after study treatment start.
Time frame: Start to month 12
Satisfaction of health care workers
Measured by Likert scales at 12 months after study treatment start.
Time frame: Start to month 12
Health economy
Incremental cost per additional treatment success, calculated as: difference in costs (between groups)/ difference in treatment success (between groups).
Time frame: Start to month 18
Plan to share: Yes — The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Supporting information: Study protocol, Sap, Icf
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