[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mdr-tb\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mdr-tb":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100630311","phase-3-feasibility-of-the-application-of-a-new-six-month-treatment-for-multidrug-resistant-tuberculosis-mdr-tb-patients-in-france-fast-mdr-100630311",false,"NCT07486024","Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France (FAST-MDR)","Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France - FAST-MDR","FAST-MDR","Inclusion criteria\n\n1. Is 18 years old or more\n2. 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\n3. Is willing and able to give informed consent to be enrolled in the research project (signed or witnessed consent if the patient is illiterate)\n4. 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;\n5. 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;\n\n   * The following contraception methods are considered effective, according to local regulation (CTFG recommendations, March 2024):\n\n     1. Combined hormonal contraception (oestrogen + progestin)\n     2. Progestin-only hormonal contraception\n     3. Intrauterine device (IUD)\n     4. Intrauterine hormone-releasing system (IUS)\n     5. Bilateral tubal occlusion\n     6. Vasectomised partner\n\n        * 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.\n6. 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)\n\nExclusion criteria :\n\n1. Is unable to take oral drugs\n2. Has known allergies, hypersensitivity or intolerance or any other medical condition and contra indications to any drug of the regimen\n3. Unwilling to comply to study procedures, at the clinician appreciation\n4. 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\n5. Is taking or needs to take contraindicated medications in association with investigational medicinal products\n6. Has ≥500 msec QTcF interval on any ECG taken at screening or baseline visits, or has any cardiac risk factor for severe arrhythmia\n7. Has severe extrapulmonary TB, including meningo-encephalitis, brain abscess, osteo-arthritis, osteomyelitis\n8. Is concurrently participating in another trial of any medicinal product\n9. Is already on a MDR\u002FRR-TB treatment regimen since 4 weeks or more, and has no need to change the treatment regimen (i.e. adverse events, treatment failure)\n10. Has significant and uncorrectable lab abnormalities at baseline: haemoglobin ≤7.9 g\u002FdL, platelet count \\\u003C75 000\u002Fmm3; absolute neutrophil count \\\u003C1 000\u002F mm3; potassium \\\u003C3.0 mEq\u002FL; serum creatinine \\>3 x upper level of normality (ULN); alanine aminotransferase (ALT) ≥3 x ULN\n11. Has peripheral neuropathy of grade 3 or 4 (CTCAE scale)\n12. Has any other condition (social or medical) which, in the opinion of the site investigator, would make the study participant unsafe\n13. Is known to be pregnant or is unwilling or unable to stop breastfeeding an infant\n14. Individuals permanently legally incompetent adults, under judicial or administrative protection and vulnerable persons","ALL","18 Years",{"count":20,"type":21},55,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","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.",[27,28,29,30],"MDR-TB","Tuberculosis Multi Drug Resistant Active","Antibiotic Resistance","Mycobacterium Tuberculosis",[27,32,33],"BPaLM","Tuberculosis Multi Drug Resistant","NOT_YET_RECRUITING","2026-03-17",{"date":37,"type":38},"2026-03-20","ACTUAL",{"date":40,"type":21},"2026-04",{"date":42,"type":21},"2032-02",{"name":44,"class":45},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100623192","phase-2-acetohydroxamic-acid-combined-with-a-short-course-regimen-for-mdr-tb-aha-plus-100623192","NCT07393438","Acetohydroxamic Acid Combined With a Short-Course Regimen for MDR-TB (AHA-PLUS)","Acetohydroxamic Acid Combined With a Short-Course Regimen for the Treatment of Multidrug-Resistant Tuberculosis: A Phase II Clinical Trial","AHA-PLUS","Inclusion Criteria:\n\n* Age 14 to \\\u003C 65 years, male or female\n* Confirmed rifampicin-resistant TB (RR-TB) or multidrug-resistant TB (MDR-TB) by molecular testing (e.g., Xpert MTB\u002FRIF) or drug susceptibility testing\n* Positive sputum culture for Mycobacterium tuberculosis or positive molecular test\n* Chest imaging consistent with active pulmonary TB, or histologically confirmed extrapulmonary TB (excluding CNS, osteoarticular, and disseminated TB)\n* Body weight ≥ 40 kg\n* Karnofsky Performance Status ≥ 50\n* Adequate laboratory parameters:\n\n  * Hemoglobin ≥ 8.0 g\u002FdL\n  * ANC ≥ 1000\u002Fmm³\n  * Platelets ≥ 75,000\u002Fmm³\n  * ALT\u002FAST ≤ 3 × ULN\n  * Total bilirubin ≤ 2 × ULN\n  * Creatinine clearance ≥ 30 mL\u002Fmin\n* QTcF interval \\\u003C 450 ms (male) or \\\u003C 470 ms (female)\n* HIV-negative, confirmed by approved testing\n* No prior exposure to bedaquiline, delamanid, or linezolid for more than 1 month\n* Female participants of childbearing potential must agree to use effective contraception and have a negative pregnancy test\n* Signed informed consent\n\nExclusion Criteria:\n\n* Central nervous system TB (e.g., TB meningitis), osteoarticular TB, or disseminated\u002Fmiliary TB\n* Known allergy or serious adverse reaction to any study drug or background regimen component\n* Known resistance to bedaquiline, delamanid, or linezolid\n* Use of anti-TB drugs within the past 30 days that may interfere with study assessments, except in documented treatment failure cases\n* Severe comorbidities, including:\n\n  * NYHA Class III-IV heart failure\n  * History or risk factors for Torsades de Pointes\n  * Child-Pugh B or C cirrhosis\n  * Uncontrolled diabetes (HbA1c \\> 10%)\n  * Active malignancy\n* Current use of QT-prolonging medications that cannot be substituted\n* Current use of MAO inhibitors or serotonergic drugs\n* BMI \\\u003C 17 kg\u002Fm² with severe malnutrition\n* Grade 3-4 peripheral neuropathy at baseline\n* Pregnant or breastfeeding women\n* Any condition that, in the investigator's judgment, may interfere with study completion or data interpretation","65 Years",{"count":57,"type":21},120,[59],"PHASE2","This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety, tolerability, and preliminary efficacy of acetohydroxamic acid (AHA) capsules combined with short-course regimens (BDLLfxC or BDCZ) in patients with multidrug-resistant tuberculosis (MDR-TB).\n\nThe primary objectives are to assess the safety and tolerability of AHA combined with short-course regimens, and to determine the recommended phase II dose (RP2D) of AHA.\n\nThe secondary objectives include evaluating the 8-week sputum culture conversion rate, pharmacokinetic parameters, and exploring DNA damage repair biomarkers as potential indicators of treatment response.",[62,63,27,64],"Multidrug-Resistant Tuberculosis","Rifampicin-resistant Tuberculosis","RR-TB",[66,67,68,69,70,71,72],"Acetohydroxamic Acid","Short-Course Regimen","BDLLfxC","BDCZ","DNA Repair","RP2D","Phase II","2026-01-31",{"date":75,"type":38},"2026-02-06",{"date":77,"type":21},"2026-02-21",{"date":79,"type":21},"2028-11-30",{"name":81,"class":45},"Shanghai Pulmonary Hospital, Shanghai, China",2,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":82},"100477154","phase-4-a-exploratory-study-of-v2v2-t-lymphocyte-based-immunotherapy-for-mdr-tb-100477154","NCT05493267","A Exploratory Study of Vγ2Vδ2 T Lymphocyte-based Immunotherapy for MDR-TB","Inclusion Criteria:\n\n* RR-TB\u002FMDR-TB (resistant to at least isoniazid and rifampicin).\n* Poor efficacy of the original treatment regimen or no response to treatment or less than 4 effective drugs.\n\nExclusion Criteria:\n\n* Immunosuppression due to co-morbidities, such as immune system disorders, tumors, etc.\n* Test confirms poor response to ZOL and IL-2 stimulation.",{"count":90,"type":21},30,[92],"PHASE4","A Exploratory Study of drug combination (zoledronic acid\u002Finterleukin 2) that specifically amplifies Vγ2Vδ2 T cells in combination with anti-tuberculosis chemotherapy for the treatment of MDR-TB.",[27,95],"Immunotherapy",[97],"MDR-TB；Immunotherapy；","RECRUITING","2022-08-08",{"date":101,"type":38},"2022-08-10",{"date":103,"type":38},"2022-08-03",{"date":105,"type":21},"2027-08-03",{"name":81,"class":45}]