[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556510":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":27,"collaborators":31,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":19,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":19,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":74,"whyStopped":19,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":19},{"fullName":5,"class":6},"Taipei Medical University WanFang Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Patients will be treated with a novel short regimen",[13],"Other: a novel short regimen",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"a novel short regimen","An intensive phase consisting of isoniazid, bedaquiline, moxifloxacin and pyrazinamide for 2 months (9 weeks). A continuation phase consisting of isoniazid, bedaquiline, and levofloxacin for 4 months (17 weeks). Treatment may be extended for 3 months (13 weeks) in patients with severe disease or with delayed culture conversion, defined by culture positive at 4 months of treatment.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Chen-Yuan Chiang, MD PhD MPH","CONTACT","+886229307930","2612","cychiang@theunion.org",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Chen-Yuan Chiang","Vice superintendent",[32,34,37,39,41,44,46,48],{"name":33,"class":6},"Hualien Tzu Chi General Hospital",{"name":35,"class":36},"Chest Hospital, Ministry of Health and Welfare, Taiwan","OTHER_GOV",{"name":38,"class":36},"Chang-Hua Hospital",{"name":40,"class":6},"Taichung Veterans General Hospital",{"name":42,"class":43},"Taichung Hospital, Ministry of Health and Welfare","UNKNOWN",{"name":45,"class":36},"Taoyuan General Hospital",{"name":47,"class":6},"Kaohsiung Veterans General Hospital.",{"name":49,"class":6},"Kaohsiung Medical University Chung-Ho Memorial Hospital","100556510","phase-3-a-short-regimen-for-rifampicin-resistant-isoniazid-susceptible-tb-100556510",false,"NCT06526039","A Short Regimen for Rifampicin-resistant Isoniazid-susceptible TB","A Short Regimen for Patients With Rifampicin-resistant Isoniazid-susceptible Tuberculosis","Inclusion Criteria:\n\nA patient will be eligible for entry to the study if he\u002Fshe:\n\n* Is willing and able to give informed consent to be enrolled in the trial treatment and follow-up (signed or witnessed consent if the patient is illiterate)\n* Is aged 18 years or older\n* Has bacteriologically-confirmed pulmonary tuberculosis by Xpert MTB\u002FRIF, other nucleic acid amplification test, or culture\n* With initial laboratory result of resistance to rifampicin by Xpert MTB\u002FRIF or Xpert MTB\u002FRIF ultra, or other DST (line probe assay, culture); and with initial laboratory result that is susceptible to isoniazid by Xpert MTB\u002FRIF or other DST. If rifampicin resistance is detected by Xpert MTB\u002FRIF or Xpert MTB\u002FRIF ultra in specimens with very low bacillary, rifampicin resistance has been confirmed by a repeat molecular test.\n* With initial laboratory result of being susceptible to rifampicin by Xpert MTB\u002FRIF or other DST (Xpert MTB\u002FRIF ultra, line probe assay, culture) but are not able to tolerate rifampicin for whom rifabutin is intolerable or clinically not indicated; and with initial laboratory result that is susceptible to isoniazid by Xpert MTB\u002FRIF or other DST\n* With initial laboratory result of being susceptible to rifampicin by Xpert MTB\u002FRIF or other DST (Xpert MTB\u002FRIF ultra, line probe assay, culture) but rifamycin-sparing regimens are preferred due to drug-drug interaction, such as organ transplant recipients; and with initial laboratory result that is susceptible to isoniazid by Xpert MTB\u002FRIF or other DST.\n* With initial laboratory result that is susceptible to fluoroquinolone by Xpert MTB\u002FXDR or other DST.\n* If HIV test positive, is willing to be treated with ART in accordance with the national policies.\n* Agrees to use effective barrier contraception or have an intrauterine contraceptive device during treatment phase if a pre-menopausal woman\n* Has an identifiable address and expects to remain in the area for the duration of the study\n* Is willing to adhere to the follow-up schedule and to study procedures\n\nExclusion Criteria:\n\nA patient will not be eligible for entry to the study if he\u002Fshe:\n\n* Is infected with a strain of M. Tuberculosis resistant to isoniazid by Xpert MTB\u002FXDR or other tests\n* Is infected with a strain of M. Tuberculosis resistant to fluoroquinolone by Xpert MTB\u002FXDR or other tests\n* Is infected with a strain of M. Tuberculosis resistant to amikacin by Xpert MTB\u002FXDR or other tests and have no result of susceptibility of isoniazid by conventional drug susceptibility testing\n* Has tuberculous meningitis or bone and joint tuberculosis\n* Is critically ill, and in the judgment of the investigator, unlikely to survive more than 4 months.\n* Is known to be pregnant or breast-feeding\n* Is unable to attend or comply with treatment or follow-up schedule\n* Is unable to take oral medication\n* Has AST or ALT \\>5 times the upper limit of normal\n* Has AST or ALT \\> 3 times the upper limit of normal ,and either with symptoms of hepatitis or bilirubin \\> 1.5 times the upper limit of normal\n* Has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe.\n* Is taking any medications contraindicated with the medicines in either the trial or control regimen\n* Has a known allergy to any fluoroquinolone antibiotic\n* Is currently taking part in another trial of a medicinal product\n* Has a QTcF interval of ≥450msec at screening","ALL","18 Years",{"count":60,"type":61},100,"ESTIMATED","INTERVENTIONAL",[64],"PHASE3","To assess outcome of treatment and safety among patients with rifampicin-resistant isoniazid-susceptible pulmonary tuberculosis treated with a novel regimen consisting of isoniazid, bedaquiline, and moxifloxacin throughout for 6 months, supplemented by pyrazinamide for the initial 2 months.",[67],"Tuberculosis, Pulmonary",[69,70,71,72,73],"bedaquiline","isoniazid","moxifloxacin","tuberculosis","rifampicin resistance","NOT_YET_RECRUITING","2024-07-24",{"date":77,"type":78},"2024-07-29","ACTUAL",{"date":80,"type":61},"2024-07",{"date":82,"type":61},"2029-12",{"name":5,"class":6}]