[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multidrug-resistant-tuberculosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multidrug-resistant-tuberculosis":102},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,53,88,120],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100623192","phase-2-acetohydroxamic-acid-combined-with-a-short-course-regimen-for-mdr-tb-aha-plus-100623192",false,"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","ALL","18 Years","65 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31],"Multidrug-Resistant Tuberculosis","Rifampicin-resistant Tuberculosis","MDR-TB","RR-TB",[33,34,35,36,37,38,39],"Acetohydroxamic Acid","Short-Course Regimen","BDLLfxC","BDCZ","DNA Repair","RP2D","Phase II","NOT_YET_RECRUITING","2026-01-31",{"date":43,"type":44},"2026-02-06","ACTUAL",{"date":46,"type":22},"2026-02-21",{"date":48,"type":22},"2028-11-30",{"name":50,"class":51},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",2,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":65,"conditions":66,"keywords":71,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100382503","phase-3-novel-triple-dose-tuberculosis-retreatment-regimen-100382503","NCT04260477","Novel Triple-dose Tuberculosis Retreatment Regimen","Novel Triple-dose Tuberculosis Retreatment Regimen: How to Overcome Resistance Without Creating More in Niger","Tri-Do-Re","Inclusion Criteria:\n\n* All newly registered patients with smear-positive recurrent pulmonary TB\n* Adults as well as children (no age limit)\n* Able and willing to provide written informed consent\n* Added for stage 2: lives within 5 km of a health facility with a medical doctor\n\nExclusion Criteria:\n\n* All patients with TB initially resistant to rifampicin on Xpert MTB\u002FRIF testing\n* Patients transferred to a health facility not supported by the Damien Foundation\n* Patients previously enrolled in the trial, and with another episode of rifampicin-susceptible TB during the study period\n* Those with grade III elevation of liver function tests at baseline, or with clinically active liver disease at screening\n* Pregnant or breastfeeding woman\n* HIV co-infected patients requiring treatment with a protease inhibitor",{"count":62,"type":22},370,[64],"PHASE3","To determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent Tuberculosis (TB).",[67,68,69,70],"Multidrug-resistant Tuberculosis","Pulmonary Tuberculosis","Tuberculosis","Resistance to Tuberculostatic Drugs",[72,69,73,74,75,76],"rifampicin-susceptible-TB","first-line","TB relapse","TB treatment failure","high dose retreatment","RECRUITING","2025-04-10",{"date":80,"type":44},"2025-04-13",{"date":82,"type":44},"2021-03-01",{"date":84,"type":22},"2025-09",{"name":86,"class":51},"Institute of Tropical Medicine, Belgium",1,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":23,"phases":99,"briefSummary":100,"conditions":101,"keywords":105,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100445512","phase-3-innovatingin-shorters-all--oral-precisedp-individualizedi-treatment-regimenre-for-rifampicin-resistant-tuberculosisinspire-tb-100445512","NCT05081401","Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)","INSPIRE-TB","Inclusion Criteria:\n\n1. Male or female patients aged 16-75 years with weight over 30kg, regardless of HIV status;\n2. Pulmonary TB with rifampicin resistance diagnosed with either WHO-approved rapid molecular diagnostic test or phenotype drug susceptibility test (within 60 days prior to randomisation) ;\n3. Signed informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Known allergies, hypersensitivity, or contraindication to any of the study drugs as described in additional material;\n2. Participants combined with central nervous system TB, tuberculous osteomyelitis or arthritis, hematogenous disseminated pulmonary TB;\n3. Patients known to be pregnant or breastfeeding at the time of enrollment;\n4. Patients who have received second-line MDR-TB treatment for 14 days or more prior to enrollment;\n5. Patients in critical condition and expected survival is estimated by physician to be less than 12 weeks.","16 Years","75 Years",{"count":98,"type":22},1050,[64],"The INSPIRE-TB study is a pragmatic, multicentre, randomised, controlled, non-inferiority open-label trial to evaluate the efficacy and safety of seven 9-month oral regimens compared to a 9-month standard of care (SOC) regimen in RR-TB participants susceptible to fluoroquinolones, and a bedaquiline-containing 9-month oral regimen compared to a 20-month conventional regimen in RR-TB participants resistant to fluoroquinolones",[102,103,104],"Multidrug Resistant Tuberculosis","Rifampicin Resistant Tuberculosis","Pre-XDR-TB",[106,107,108,109],"multidrug resistant tuberculosis","shorter treatment","all-oral regimen","PZA sensitivity","2025-04-01",{"date":112,"type":44},"2025-04-06",{"date":114,"type":44},"2022-05-23",{"date":116,"type":22},"2027-12-01",{"name":118,"class":51},"Huashan Hospital",5,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":96,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":87},"100480343","phase-2-evaluation-of-the-early-bactericidal-activity-of-tedizolid-and-linezolide-against-mycobacterium-tuberculosis-teditub-100480343","NCT05534750","Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB)","Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis","TEDITUB","Inclusion Criteria:\n\n* Age ≥ 18 years old and \\\u003C75 years old\n* Woman on childbearing age should be on effective contraception during the duration of the study and up to 6 months after treatment; a mechanical contraception (use of condom) will be strongly recommended\n* Male (effective contraception must be used during duration of the study and up to 3 months after treatment)\n* Patient with a first infection with Mycobacterium tuberculosis of pulmonary localization suspected by the presence of a clinical pulmonary symptomatology, a chest X-ray or an abnormal chest computed tomography, and the positive microscopic examination of a sputum (AFB +, presence of AFB) with confirmation of tuberculosis by a genotypic test demonstrating no resistance to rifampicin, without clinical signs of extra-thoracic involvement\n* State medical assistance application being processed ( If patient does not benefit from social security),\n* Signature of informed consent\n\nExclusion Criteria:\n\n* Resistance to one of the anti-tuberculosis drugs used detected by a genotypic test in accordance with the recommendations of the High Council of Public Health of 2015;\n* History of anti-tuberculosis treatment (patients with a documented negative genotypic test for isoniazid and rifampicin resistance may be included)\n* History of treatment in the previous two years with one of the antibiotics evaluated in this trial lasting more than one month;\n* Absolute contraindication to the use of at least one of the test molecules (isoniazid, rifampicin, ethambutol, pyrazinamide, linezolid, tedizolid);\n* Tuberculosis having, in the opinion of the investigator, severity criteria not allowing to wait 7 days before starting standard treatment (oxygenorequirement, severe immunosuppression, extra-pulmonary involvement, any sign of severity requiring treatment in intensive care unit);\n* HIV-infected patient receiving protease inhibitors whose antiviral treatment cannot be changed and therefore cannot receive rifampicin; or any other drug contraindicated with one of the study treatments (the list of contraindicated drugs is detailed in the following non-inclusion criteria).\n* Neoplastic pathology during treatment with chemo and \u002F or radiotherapy;\n* Decompensated cirrhosis;\n* Pregnancy, desire to become pregnant, breast-feeding (for women of childbearing potential, contraception should be used for the duration of the study and up to 6 months after treatment, mechanical contraception will be strongly recommended and up to 3 months after treatment);\n* Protected adults (under guardianship, curatorship) and under safeguard of justice\n* Significant laboratory abnormalities (hemoglobin \\\u003C9g \u002F dl, polynuclear neutrophils \\\u003C500 \u002F mm3, platelets \\\u003C50,000 \u002F mm3, creatinine clearance \\\u003C30ml \u002F min, ASAT or ALAT\\> 3N, and total bilirubin\\> 3N)\n* Hyperuricaemia\n* Porphyria\n* Optic neuritis or peripheral neuropathy\n* BMI≤ 16 kg\u002Fm2\n* Participation in other interventional research\n* Current treatment with one or more medications contraindicated in combination with linezolid: Linezolid should not be used in patients treated with monoamine oxidase A or B inhibitors (for example: phenelzine, isocarboxacid, selegiline, moclobemide) or who received one of these products in the previous two weeks\n* Current treatment with one or more medications contraindicated in combination with quadritherapy:\n* Combination with bictegravir, cobicistat, daclatasvir, dasabuvir, delamanid, grazoprevir\u002Felbasvir, protease inhibitors boosted by ritonavir, isavuconazole, ledipasvir, lurasidone, midostaurin, ombitasvir\u002Fparitaprevir, praziquantel, rilpivirine, sofosbuvir, velpatasvir, voriconazole, voxilaprevir\n* Gastrointestinal topicals, antacids and adsorbents and salts and aluminum hydroxides",{"count":129,"type":22},60,[25],"The objective of this work is to measure the early bactericidal activity of tedizolid, to compare it with the bactericidal activity of linezolid (reference molecule for the treatment of multidrug-resistant tuberculosis) and with that of standard quadruple therapy (reference treatment of drug susceptible tuberculosis).",[69,102],[69,134,135,136,137,138,139,140,141],"Multidrug Resistant","Linezolid","Tedizolid","Pyrazinamide","Rifampicin","Isionazid","Ethambutol","Early Bactericidal Activity","2025-01-31",{"date":144,"type":44},"2025-02-03",{"date":146,"type":44},"2023-04-20",{"date":148,"type":22},"2026-05",{"name":150,"class":51},"Assistance Publique - Hôpitaux de Paris"]