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Clinical Trial NCT07486024 (FAST-MDR) for MDR-TB, Tuberculosis Multi Drug Resistant Active, Antibiotic Resistance, Mycobacterium Tuberculosis is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Assistance Publique - Hôpitaux de ParisFeasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France (FAST-MDR) Phase 3 55
Clinical Trial NCT07486024 (FAST-MDR) is designed to study Treatment for MDR-TB, Tuberculosis Multi Drug Resistant Active, Antibiotic Resistance, Mycobacterium Tuberculosis. This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on 1 April 2026 until the study accrues 55 participants. Led by Assistance Publique - Hôpitaux de Paris, this study is expected to complete by 1 February 2032. The latest data from ClinicalTrials.gov was last updated on 20 March 2026.
Brief 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 ...Show More
Detailed Description
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 ...
Show MoreOfficial Title
Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France - FAST-MDR
Conditions
MDR-TBTuberculosis Multi Drug Resistant ActiveAntibiotic ResistanceMycobacterium TuberculosisOther Study IDs
- FAST-MDR
NCT ID Number
Start Date (Actual)
2026-04
Last Update Posted
2026-03-20
Completion Date (Estimated)
2032-02
Enrollment (Estimated)
55
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Keywords
MDR-TB
BPaLM
Tuberculosis Multi Drug Resistant
BPaLM
Tuberculosis Multi Drug Resistant
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalBedaquiline - 400 mg Posology : 400 mg once daily for 2 weeks and then 200 mg thrice weekly for the remaining 22 weeks. | 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 |
ExperimentalBedaquiline - 200 mg Posology : 200 mg once daily for 8 weeks and then 100 mg daily for the remaining 16 weeks. | Bedaquiline Oral Tablet Bedaquiline will be given as 200 mg once daily for 8 weeks and then 100 mg daily for the remaining 16 weeks |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) | Day 0 to Month 18 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Early markers of BPaLM effectiveness (proportion of participants) | Proportion of participants with a negative sputum culture at two months after study treatment start | 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) | 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 \[all according to 2021 WHO definitions\] | 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 \[all according to 2021 WHO definitions\] | 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 | 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 | 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. | 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 \[CTCAE Severity Scale v 5.0\] | Start to month 18 |
Pharmacology effectiveness (pharmacokinetic analyses) | Defined as population pharmacokinetic analyses for each drug | 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 | 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 | 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. | 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. | Start to month 18 |
Microbiology eligibility - diagnostic delay (interventional group only) | Defined as time between screening and microbiological eligibilty assessment | 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 | Start to Month 1 |
Treatment adherence (interventional group only) | Proportion of doses taken out of total expected doses | 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 | 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 | 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 | Start to month 12 |
Satisfaction of study participants | Measured by Likert scales at 12 months after study treatment start. | Start to month 12 |
Satisfaction of health care workers | Measured by Likert scales at 12 months after study treatment start. | 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). | Start to month 18 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
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;
The following contraception methods are considered effective, according to local regulation (CTFG recommendations, March 2024):
Combined hormonal contraception (oestrogen + progestin)
Progestin-only hormonal contraception
Intrauterine device (IUD)
Intrauterine hormone-releasing system (IUS)
Bilateral tubal occlusion
Vasectomised partner
- A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
Is affiliated to a social security system (as beneficiary) or has state medical aid (AME) or has an ongoing demand for AMEor has an ongoing demand for an emergency medical care (dispositif de soins d'urgence, as applicable for tuberculosis)
- 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
- Is taking or needs to take contraindicated medications in association with investigational medicinal products
- Has ≥500 msec QTcF interval on any ECG taken at screening or baseline visits, or has any cardiac risk factor for severe arrhythmia
- Has severe extrapulmonary TB, including meningo-encephalitis, brain abscess, osteo-arthritis, osteomyelitis
- Is concurrently participating in another trial of any medicinal product
- 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)
- 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
- Has peripheral neuropathy of grade 3 or 4 (CTCAE scale)
- Has any other condition (social or medical) which, in the opinion of the site investigator, would make the study participant unsafe
- Is known to be pregnant or is unwilling or unable to stop breastfeeding an infant
- Individuals permanently legally incompetent adults, under judicial or administrative protection and vulnerable persons
Assistance Publique - Hôpitaux de Paris967 active studies to exploreViatris Inc.14 active studies to exploreStudy Central Contact
Contact: Lorenzo GUGLIELMETTI, MD, 01 40 77 97 46, [email protected]
1 Study Locations in 1 Countries
Pitié-Salpêtrière Hospital - infectious and tropical diseases, Paris, France
Valérie POURCHER, Contact, 01 42 16 02 62, [email protected]