[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pre-xdr-tb\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pre-xdr-tb":29},{"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":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":20,"type":21},1050,"ESTIMATED","INTERVENTIONAL",[24],"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",[27,28,29],"Multidrug Resistant Tuberculosis","Rifampicin Resistant Tuberculosis","Pre-XDR-TB",[31,32,33,34],"multidrug resistant tuberculosis","shorter treatment","all-oral regimen","PZA sensitivity","RECRUITING","2025-04-01",{"date":38,"type":39},"2025-04-06","ACTUAL",{"date":41,"type":39},"2022-05-23",{"date":43,"type":21},"2027-12-01",{"name":45,"class":46},"Huashan Hospital","OTHER",5]