[{"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":147},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,52,86,117],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"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":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"Multidrug-Resistant Tuberculosis","Rifampicin-resistant Tuberculosis","MDR-TB","RR-TB",[32,33,34,35,36,37,38],"Acetohydroxamic Acid","Short-Course Regimen","BDLLfxC","BDCZ","DNA Repair","RP2D","Phase II","NOT_YET_RECRUITING","2026-01-31",{"date":42,"type":43},"2026-02-06","ACTUAL",{"date":45,"type":21},"2026-02-21",{"date":47,"type":21},"2028-11-30",{"name":49,"class":50},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",2,{"id":53,"slug":4,"hasResults":10,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":10,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"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":60,"type":21},370,[62],"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).",[65,66,67,68],"Multidrug-resistant Tuberculosis","Pulmonary Tuberculosis","Tuberculosis","Resistance to Tuberculostatic Drugs",[70,67,71,72,73,74],"rifampicin-susceptible-TB","first-line","TB relapse","TB treatment failure","high dose retreatment","RECRUITING","2025-04-10",{"date":78,"type":43},"2025-04-13",{"date":80,"type":43},"2021-03-01",{"date":82,"type":21},"2025-09",{"name":84,"class":50},"Institute of Tropical Medicine, Belgium",1,{"id":87,"slug":4,"hasResults":10,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":10,"sex":16,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":102,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"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":95,"type":21},1050,[62],"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",[99,100,101],"Multidrug Resistant Tuberculosis","Rifampicin Resistant Tuberculosis","Pre-XDR-TB",[103,104,105,106],"multidrug resistant tuberculosis","shorter treatment","all-oral regimen","PZA sensitivity","2025-04-01",{"date":109,"type":43},"2025-04-06",{"date":111,"type":43},"2022-05-23",{"date":113,"type":21},"2027-12-01",{"name":115,"class":50},"Huashan Hospital",5,{"id":118,"slug":4,"hasResults":10,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":93,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":85},"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":125,"type":21},60,[24],"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).",[67,99],[67,130,131,132,133,134,135,136,137],"Multidrug Resistant","Linezolid","Tedizolid","Pyrazinamide","Rifampicin","Isionazid","Ethambutol","Early Bactericidal Activity","2025-01-31",{"date":140,"type":43},"2025-02-03",{"date":142,"type":43},"2023-04-20",{"date":144,"type":21},"2026-05",{"name":146,"class":50},"Assistance Publique - Hôpitaux de Paris",""]