[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rr-tb\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rr-tb":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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]