[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100445512":3},{"organization":4,"armGroups":7,"interventions":60,"overallOfficials":94,"centralContacts":98,"locations":108,"responsibleParty":182,"collaborators":66,"id":185,"slug":186,"hasResults":187,"nctId":188,"briefTitle":189,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":187,"sex":192,"minAge":193,"maxAge":194,"enrollmentInfo":195,"targetDuration":66,"studyType":198,"phases":199,"briefSummary":201,"conditions":202,"keywords":206,"overallStatus":111,"whyStopped":66,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},{"fullName":5,"class":6},"Huashan Hospital","OTHER",[8,14,20,25,30,35,40,45,50,55],{"label":9,"type":10,"description":11,"interventionNames":12},"A-SOC","ACTIVE_COMPARATOR","The control arm for fluroquinolones susceptible participants is the current standard of care oral regimen for RR-TB recommended by Chinese national guidelines. The SOC regimen comprise one or two group A drugs(bedaquiline or linezolid, moxifloxacin or levofloxacin) and one group B drug(clofazimine or cycloserine) along with other companion drugs.",[13],"Combination Product: Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z",{"label":15,"type":16,"description":17,"interventionNames":18},"A1","EXPERIMENTAL","The experimental A1 arm in fluroquinolones susceptible participants is a 9-month regimen consisted of bedaquiline, linezolid, fluroquinolones(moxifloxacin or levofloxacin), cycloserine, clofazimine.",[19],"Combination Product: A1",{"label":21,"type":16,"description":22,"interventionNames":23},"A2a","The experimental A2a arm in fluroquinolones susceptible participants is a 9-month regimen consisted of bedaquiline, linezolid, fluroquinolones(moxifloxacin or levofloxacin), cycloserine, pyrazinamide. The dosage of linezolid is 600mg daily for 9 months.",[24],"Combination Product: A2a",{"label":26,"type":16,"description":27,"interventionNames":28},"A2b","The experimental A2b arm in fluroquinolones susceptible participants is a 9-month regimen consisted of bedaquiline, linezolid, fluroquinolones(moxifloxacin or levofloxacin), cycloserine, pyrazinamide. The dosage of linezolid is 600mg daily for 2 months.",[29],"Combination Product: A2b",{"label":31,"type":16,"description":32,"interventionNames":33},"A2c","The experimental A2c arm in fluroquinolones susceptible participants is a 9-month regimen consisted of bedaquiline, linezolid, fluroquinolones(moxifloxacin or levofloxacin), cycloserine, pyrazinamide. The dosage of linezolid is 600mg daily for 2 months and then 300mg daily for 7 months.",[34],"Combination Product: A2c",{"label":36,"type":16,"description":37,"interventionNames":38},"A3","The experimental A3 arm in fluroquinolones susceptible participants is a 9-month regimen consisted of bedaquiline, linezolid, fluroquinolones(moxifloxacin or levofloxacin), clofazimide, pyrazinamide.",[39],"Combination Product: A3",{"label":41,"type":16,"description":42,"interventionNames":43},"A4","The experimental A4 arm in fluroquinolones susceptible participants is a 9-month regimen consisted of bedaquiline, fluroquinolones(moxifloxacin or levofloxacin), clofazimide, cycloserine, pyrazinamide.",[44],"Combination Product: A4",{"label":46,"type":16,"description":47,"interventionNames":48},"A5","The experimental A4 arm in fluroquinolones susceptible participants is a 9-month regimen consisted of fluroquinolones(moxifloxacin or levofloxacin), linezolid, clofazimide, cycloserine, pyrazinamide.",[49],"Combination Product: A5",{"label":51,"type":10,"description":52,"interventionNames":53},"B-SOC","In fluroquinolones resistant participants, the comparator is a locally approved standard of care long regimen which is consistent with local guidelines for treatment of RR-TB in China and WHO recommendations. The control arm contain bedaquiline, cycloserine, clofazimine, and linezolid. Treatment duration is 20 months, with a 6-month intensive phase and a 14-month continuation phase.",[54],"Combination Product: B-SOC",{"label":56,"type":16,"description":57,"interventionNames":58},"B1","In fluroquinolones resistant participants, the arm B1 is a 9-month treatment regimen with a combination of five drugs: bedaquiline, cycloserine, clofazimine, linezolid, pyrazinamide.",[59],"Combination Product: B1",[61,67,70,73,76,79,82,85,88,91],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"COMBINATION_PRODUCT","Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z","A-SOC: 4Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z\u002F5Lfx(Mfx)+Cfz(Cs)+E+Z During the intensive phase: Bedaquiline(Linezolid);Levofloxacin(Moxifloxacin) All treatment is taken orally",[9],null,{"type":62,"name":15,"description":68,"armGroupLabels":69,"otherNames":66},"9Bdq(6m)+Fq+Lzd+Cs+Cfz",[15],{"type":62,"name":21,"description":71,"armGroupLabels":72,"otherNames":66},"9Bdq(6m)+Fq+Lzd(600mg)+Cs+Z",[21],{"type":62,"name":26,"description":74,"armGroupLabels":75,"otherNames":66},"9Bdq(6m)+Fq+Lzd(2m)+Cs+Z",[26],{"type":62,"name":31,"description":77,"armGroupLabels":78,"otherNames":66},"9Bdq(6m)+Fq+Lzd(600mg-300mg)+Cs+Z",[31],{"type":62,"name":36,"description":80,"armGroupLabels":81,"otherNames":66},"9Bdq(6m)+Fq+Lzd+Cfz+Z",[36],{"type":62,"name":41,"description":83,"armGroupLabels":84,"otherNames":66},"9Bdq(6m)+Fq+Cfz+Cs+Z",[41],{"type":62,"name":46,"description":86,"armGroupLabels":87,"otherNames":66},"9Fq+Lzd+Cfz+Cs+Z",[46],{"type":62,"name":51,"description":89,"armGroupLabels":90,"otherNames":66},"6Bdq+Lzd+Cs+Cfz\u002F14Lzd+Cfz+Cs",[51],{"type":62,"name":56,"description":92,"armGroupLabels":93,"otherNames":66},"9Bdq(6m)+Lzd+Cs+Cfz+Z",[56],[95],{"name":96,"affiliation":5,"role":97},"Wenhong Zhang, PHD","PRINCIPAL_INVESTIGATOR",[99,104],{"name":100,"role":101,"phone":102,"phoneExt":66,"email":103},"Feng Sun, Dr.","CONTACT","(086)15921403893","feng.sun@nmcid.org.cn",{"name":105,"role":101,"phone":106,"phoneExt":66,"email":107},"Yang Li, Dr.","(086)18817583793","lalaliy@sina.com",[109,126,137,148,159],{"facility":110,"status":111,"city":112,"state":113,"zip":66,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":122},"Guiyang Public Health Treatment Center","RECRUITING","Guiyang","Guizhou","China","CN",{"type":117,"coordinates":118},"Point",[119,120],106.71667,26.58333,{"lat":120,"lon":119},[123],{"name":124,"role":101,"phone":66,"phoneExt":66,"email":125},"Zhongfeng Huang","1017899870@qq.com",{"facility":127,"status":111,"city":128,"state":113,"zip":66,"country":114,"countryCode":115,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"People's Hospital of Qiandongnan","Kaili",{"type":117,"coordinates":130},[131,132],107.97972,26.58583,{"lat":132,"lon":131},[135],{"name":136,"role":101,"phone":66,"phoneExt":66,"email":66},"Jing Wang",{"facility":138,"status":111,"city":139,"state":113,"zip":66,"country":114,"countryCode":115,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"The Third People's Hospital of Liupanshui","Liupanshui",{"type":117,"coordinates":141},[142,143],104.83333,26.59444,{"lat":143,"lon":142},[146],{"name":147,"role":101,"phone":66,"phoneExt":66,"email":66},"Chunlong Zhang",{"facility":149,"status":111,"city":150,"state":113,"zip":66,"country":114,"countryCode":115,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Affiliated Hospital of Zunyi Medical University","Zunyi",{"type":117,"coordinates":152},[153,154],106.90722,27.68667,{"lat":154,"lon":153},[157],{"name":158,"role":101,"phone":66,"phoneExt":66,"email":66},"Jianyong Zhang",{"facility":160,"status":111,"city":161,"state":162,"zip":163,"country":114,"countryCode":115,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Huashan Hospital of Fudan University","Shanghai","Shanghai Municipality","200040",{"type":117,"coordinates":165},[166,167],121.45806,31.22222,{"lat":167,"lon":166},[170,175,178,180],{"name":171,"role":101,"phone":172,"phoneExt":173,"email":174},"Wenhong Zhang, PhD, MD","+86 21 52889999","8123","zhangwenhong@fudan.edu.cn",{"name":176,"role":177,"phone":66,"phoneExt":66,"email":66},"Feng Sun","SUB_INVESTIGATOR",{"name":179,"role":177,"phone":66,"phoneExt":66,"email":66},"Yang Li",{"name":181,"role":177,"phone":66,"phoneExt":66,"email":66},"Yilin Zhang",{"type":97,"investigatorFullName":183,"investigatorTitle":184,"investigatorAffiliation":5,"oldNameTitle":66,"oldOrganization":66},"Wen-hong Zhang","Director of Division of Infectious Diseases","100445512","phase-3-innovatingin-shorters-all--oral-precisedp-individualizedi-treatment-regimenre-for-rifampicin-resistant-tuberculosisinspire-tb-100445512",false,"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.","ALL","16 Years","75 Years",{"count":196,"type":197},1050,"ESTIMATED","INTERVENTIONAL",[200],"PHASE3","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",[203,204,205],"Multidrug Resistant Tuberculosis","Rifampicin Resistant Tuberculosis","Pre-XDR-TB",[207,208,209,210],"multidrug resistant tuberculosis","shorter treatment","all-oral regimen","PZA sensitivity","2025-04-01",{"date":213,"type":214},"2025-04-06","ACTUAL",{"date":216,"type":214},"2022-05-23",{"date":218,"type":197},"2027-12-01",{"name":5,"class":6},5]