[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623192":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":77,"collaborators":26,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":26,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":103,"overallStatus":110,"whyStopped":26,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AHA plus Short-Course Regimen","EXPERIMENTAL","Participants in this arm receive acetohydroxamic acid (AHA) in combination with a short-course anti-tuberculosis regimen. AHA is administered at the protocol-defined dose and schedule. All background treatments are identical to those in the control arm.",[13],"Drug: Acetohydroxamic Acid",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo plus Short-Course Regimen","PLACEBO_COMPARATOR","Participants in this arm receive a matching placebo in combination with the same short-course anti-tuberculosis regimen used in the experimental arm. The placebo is identical in appearance, packaging, and administration schedule to maintain blinding.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Acetohydroxamic Acid","Acetohydroxamic acid administered according to the protocol-defined dose and schedule, in combination with a short-course anti-tuberculosis regimen.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Matching placebo identical in appearance, packaging, and administration schedule to acetohydroxamic acid, administered with the same short-course anti-tuberculosis regimen.",[15],[32],{"name":33,"affiliation":5,"role":34},"liu yidian","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"liu yidian, MD","CONTACT","021-65115006","liuyidian115@139.com",[42,61],{"facility":43,"status":26,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Anhui Chest Hospital","Hefei","Anhui","230000","China","CN",{"type":50,"coordinates":51},"Point",[52,53],117.28083,31.86389,{"lat":53,"lon":52},[56,60],{"name":57,"role":38,"phone":58,"phoneExt":26,"email":59},"Wang Hua, MD","0551-6362-3114","1726553540@qq.com",{"name":57,"role":38,"phone":58,"phoneExt":26,"email":26},{"facility":62,"status":26,"city":63,"state":64,"zip":65,"country":47,"countryCode":48,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Shanghai Pulmonary Hospital","Shanghai","Shanghai Municipality","200433",{"type":50,"coordinates":67},[68,69],121.45806,31.22222,{"lat":69,"lon":68},[72,73,76],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":74,"role":38,"phone":39,"phoneExt":26,"email":75},"Fan Liping","fkyyflp@163.com",{"name":37,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"yidian liu","Principal Investigator","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":92,"type":93},120,"ESTIMATED","INTERVENTIONAL",[96],"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.",[99,100,101,102],"Multidrug-Resistant Tuberculosis","Rifampicin-resistant Tuberculosis","MDR-TB","RR-TB",[23,104,105,106,107,108,109],"Short-Course Regimen","BDLLfxC","BDCZ","DNA Repair","RP2D","Phase II","NOT_YET_RECRUITING","2026-01-31",{"date":113,"type":114},"2026-02-06","ACTUAL",{"date":116,"type":93},"2026-02-21",{"date":118,"type":93},"2028-11-30",{"name":5,"class":6},2]