임상 레이더 AI | ||
|---|---|---|
임상시험 NCT07486024 (FAST-MDR)은(는) 다제내성 결핵, Tuberculosis Multi Drug Resistant Active, 항생제 내성, 결핵균에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
검색으로 돌아가기
파리 공립병원 연합Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France (FAST-MDR) 3상 55
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07486024 (FAST-MDR)은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 다제내성 결핵, Tuberculosis Multi Drug Resistant Active, 항생제 내성, 결핵균에 대해 진행되며, 3상 중재연구으로 현재 상태는 대상자모집전입니다. 참여 신청은 2026년 4월 1일부터 가능하며, 55명의 참여자를 모집할 예정입니다. 파리 공립병원 연합이(가) 진행하는 이 연구는 2032년 2월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 20일에 갱신되었습니다.
간단한 개요
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 ...더 보기
상세한 설명
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 ...
더 보기공식 제목
Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France - FAST-MDR
질환명
다제내성 결핵Tuberculosis Multi Drug Resistant Active항생제 내성결핵균기타 연구 식별자
- FAST-MDR
NCT 번호
실제 연구 시작일
2026-04
최신 업데이트 게시
2026-03-20
예상 연구 완료일
2032-02
계획된 등록 인원
55
연구종류
중재연구
단계/상
3상
상태
대상자모집전
키워드
MDR-TB
BPaLM
Tuberculosis Multi Drug Resistant
BPaLM
Tuberculosis Multi Drug Resistant
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Bedaquiline - 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 |
실험적Bedaquiline - 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 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
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
파리 공립병원 연합967개의 진행 중인 임상시험 탐색 가능연구 대표 연락처
연락처: Lorenzo GUGLIELMETTI, MD, 01 40 77 97 46, [email protected]
1 1개국에 임상시험 장소
Pitié-Salpêtrière Hospital - infectious and tropical diseases, Paris, France
Valérie POURCHER, 연락처, 01 42 16 02 62, [email protected]