[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100470072":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":45,"centralContacts":50,"locations":61,"responsibleParty":142,"collaborators":34,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":147,"sex":153,"minAge":154,"maxAge":155,"enrollmentInfo":156,"targetDuration":34,"studyType":159,"phases":160,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":113,"whyStopped":34,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Huashan Hospital","OTHER",[8,14,19,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Short Regimen with Rifapentine 10mg\u002Fkg","EXPERIMENTAL","Intervention: Short Regimen with Rifapentine 10mg\u002Fkg consists of two periods of 17- 26 weeks. The first is an intensive phase of 8 weeks, and included rifapentine, isoniazid, pyrazinamide, and moxifloxacin. This is followed by a continuation phase of 9 weeks with the following agents: rifapentine, isoniazid and moxifloxacin (extended up a maximum of 18 weeks if no smear conversion at the end of 8 weeks or the tuberculosis cavity is not closed at the end of 17 weeks).",[13],"Other: Short Regimen with Rifapentine 10mg\u002Fkg",{"label":15,"type":10,"description":16,"interventionNames":17},"Short Regimen with Rifapentine 15mg\u002Fkg","Intervention: Short Regimen with Rifapentine 15mg\u002Fkg consists of two periods of 17- 26 weeks. The first is an intensive phase of 8 weeks, and included rifapentine, isoniazid, pyrazinamide, and moxifloxacin. This is followed by a continuation phase of 9 weeks with the following agents: rifapentine, isoniazid and moxifloxacin (extended up a maximum of 18 weeks if no smear conversion at the end of 8 weeks or the tuberculosis cavity is not closed at the end of 17 weeks).",[18],"Other: Short Regimen with Rifapentine 15mg\u002Fkg",{"label":20,"type":21,"description":22,"interventionNames":23},"Standardized Regimen","ACTIVE_COMPARATOR","Intervention：World Health Organization (WHO) Standardized Regimen group consists of 26 weeks with two phases of treatment. The first is an intensive phase of 8 weeks, and included rifampicin, isoniazid, pyrazinamide, and ethambutol. This is followed by a continuation phase of 18 weeks with the following agents: rifampicin and isoniazid.",[24],"Combination Product: Standardized Regimen",{"label":26,"type":10,"description":27,"interventionNames":28},"Short Regimen with Rifapentine 20mg\u002Fkg","Intervention: Short Regimen with Rifapentine 20mg\u002Fkg consists of two periods of 17- 26 weeks. The first is an intensive phase of 8 weeks, and included rifapentine, isoniazid, pyrazinamide, and moxifloxacin. This is followed by a continuation phase of 9 weeks with the following agents: rifapentine, isoniazid and moxifloxacin (extended up a maximum of 18 weeks if no smear conversion at the end of 8 weeks or the tuberculosis cavity is not closed at the end of 17 weeks).",[29],"Other: Short Regimen with Rifapentine 20mg\u002Fkg",[31,35,39,42],{"type":6,"name":9,"description":32,"armGroupLabels":33,"otherNames":34},"rifapentine 10mg\u002Fkg daily; isoniazid 300mg daily; pyrazinamide ≤50kg 1000mg daily, 50-71kg 1200mg daily, \\>71kg 1000mg daily; moxifloxacin 400mg daily. All treatment is taken orally.",[9],null,{"type":36,"name":20,"description":37,"armGroupLabels":38,"otherNames":34},"COMBINATION_PRODUCT","During the intensive phase, rifampicin ≤55kg 450mg daily, 55-71kg 600mg daily, \\>71kg 750mg daily; isoniazid ≤55kg 225mg daily, 55-71kg 300mg daily, \\>71kg 375mg daily; pyrazinamide ≤55kg 900mg daily, 55-71kg 1200mg daily, \\>71kg 1600mg daily; ethambutol ≤55kg 825mg daily, 55-71kg 1100mg daily, \\>71kg 1375mg daily; All treatment is taken orally.\n\nDuring the continuation phase, rifampicin ≤50kg 450mg daily, \\>50kg 600mg daily; isoniazid 300mg daily; All treatment is taken orally.",[20],{"type":6,"name":15,"description":40,"armGroupLabels":41,"otherNames":34},"rifapentine 15mg\u002Fkg daily; isoniazid 300mg daily; pyrazinamide ≤50kg 1000mg daily, 50-71kg 1200mg daily, \\>71kg 1000mg daily; moxifloxacin 400mg daily. All treatment is taken orally.",[15],{"type":6,"name":26,"description":43,"armGroupLabels":44,"otherNames":34},"rifapentine 20mg\u002Fkg daily; isoniazid 300mg daily; pyrazinamide ≤50kg 1000mg daily, 50-71kg 1200mg daily, \\>71kg 1000mg daily; moxifloxacin 400mg daily. All treatment is taken orally.",[26],[46],{"name":47,"affiliation":48,"role":49},"Wenhong Zhang, PhD.","Huashan Hospital of Fudan University，Shanghai，China","PRINCIPAL_INVESTIGATOR",[51,57],{"name":52,"role":53,"phone":54,"phoneExt":55,"email":56},"Feng Sun, Dr.","CONTACT","(086)15921403893","8123","aaronsf1125@126.com",{"name":58,"role":53,"phone":59,"phoneExt":55,"email":60},"Yang Li, Dr.","(086)18817583793","y_li11@fudan.edu.cn",[62,78,89,100,111,127],{"facility":63,"status":64,"city":65,"state":66,"zip":34,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Guiyang Public Health Clinical Center","NOT_YET_RECRUITING","Guiyang","Guizhou","China","CN",{"type":70,"coordinates":71},"Point",[72,73],106.71667,26.58333,{"lat":73,"lon":72},[76],{"name":77,"role":53,"phone":34,"phoneExt":34,"email":34},"Cui Cai",{"facility":79,"status":64,"city":80,"state":66,"zip":34,"country":67,"countryCode":68,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"People's Hospital of Qiandongnan","Kaili",{"type":70,"coordinates":82},[83,84],107.97972,26.58583,{"lat":84,"lon":83},[87],{"name":88,"role":53,"phone":34,"phoneExt":34,"email":34},"Jing Wang",{"facility":90,"status":64,"city":91,"state":66,"zip":34,"country":67,"countryCode":68,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"The Third People's Hospital of Liupanshui","Liupanshui",{"type":70,"coordinates":93},[94,95],104.83333,26.59444,{"lat":95,"lon":94},[98],{"name":99,"role":53,"phone":34,"phoneExt":34,"email":34},"Chunlong Zhang",{"facility":101,"status":64,"city":102,"state":66,"zip":34,"country":67,"countryCode":68,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Affiliated Hospital of Zunyi Medical University","Zunyi",{"type":70,"coordinates":104},[105,106],106.90722,27.68667,{"lat":106,"lon":105},[109],{"name":110,"role":53,"phone":34,"phoneExt":34,"email":34},"Jianyong Zhang",{"facility":112,"status":113,"city":114,"state":115,"zip":116,"country":67,"countryCode":68,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Department of Infectious Disease, Huashan Hospital","RECRUITING","Shanghai","Shanghai Municipality","200040",{"type":70,"coordinates":118},[119,120],121.45806,31.22222,{"lat":120,"lon":119},[123],{"name":124,"role":53,"phone":125,"phoneExt":34,"email":126},"Hongyu Wang","17717366509","rubywang961208@gmail.com",{"facility":128,"status":64,"city":129,"state":130,"zip":131,"country":67,"countryCode":68,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"People's Hospital of Zhuji, Zhejiang Province","Zhuji","Zhejiang","311899",{"type":70,"coordinates":133},[134,135],120.24233,29.71877,{"lat":135,"lon":134},[138],{"name":139,"role":53,"phone":140,"phoneExt":34,"email":141},"Heqing Huang","13858516315","zjganran@163.com",{"type":49,"investigatorFullName":143,"investigatorTitle":144,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Wen-hong Zhang","Director of Division of Infectious Diseases","100470072","phase-2-optimizingo-rifapentine-basedri-regimen-and-shorteningen-the-treatment-of-drug-sensitive-tuberculosist-100470072",false,"NCT05401071","Optimizing(O) RIfapentine-based(RI) Regimen and shortENing(EN) the Treatment of Drug-sensitive Tuberculosis(T)","Efficacy and Safety of Short-course Treatment for Drug-sensitive Tuberculosis in China","ORIENT","Inclusion Criteria:\n\n* Age between 18 to 60 years;\n* Weight between 40 to 80 kg;\n* Individuals with smear-positive pulmonary tuberculosis and sensitive to rifampicin ;\n* Willing to provide signed informed consent, or parental consent and participant assent.\n* If you are a non-menopausal woman, agree to use or have used effective contraception during treatment.\n\nExclusion Criteria:\n\n* Combined extrapulmonary tuberculosis;\n* Patients with extensive lesion (extent of disease greater than 50% or cavity size greater than 4cm) ;\n* Individuals will be excluded from enrollment if, at the time of enrollment, their M. tuberculosis isolate is already known to be resistant to any one or more of the following: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones;\n* Alcohol abuse#drinking more than 64g of ethanol a day for male, 42g for female#;\n* Hemoglobin is less than 70g\u002FL or platelet is less than 100\\*10\\^9\u002FL;\n* Patients with impaired liver function (hepatic encephalopathy, ascites; total bilirubin is higher than the upper limit of normal; Alanine aminotransferase or aspartate aminotransferase is higher than the upper limit of normal);\n* Blood creatinine is more than 1.5 times the upper limit of normal;\n* More than five days of systemic treatment with any one or more of the following drugs within 6 months preceding initiation of study drugs: isoniazid, rifampin, rifabutin, rifapentine, ethambutol, pyrazinamide, kanamycin, amikacin, streptomycin, capreomycin, moxifloxacin, levofloxacin, gatifloxacin, ofloxacin, ciprofloxacin, other fluoroquinolones, ethionamide, prothionamide, cycloserine, terizidone, para-aminosalicylic acid, linezolid, clofazimine, delamanid or bedaquiline;\n* Known history of prolonged QT syndrome;\n* Current or planned use within six months following enrollment of one or more of the following medications: HIV protease inhibitors, HIV integrase inhibitors, HIV entry and fusion inhibitors, HIV non-nucleoside reverse transcriptase inhibitors other than efavirenz; quinidine, procainamide, amiodarone, sotalol, disopyramide, ziprasidone, or terfenadine;\n* Known allergy or intolerance to any of the study medications;\n* AIDS patients;\n* Pregnant or breast-feeding.","ALL","18 Years","60 Years",{"count":157,"type":158},2442,"ESTIMATED","INTERVENTIONAL",[161,162],"PHASE2","PHASE3","Tuberculosis (TB) remains the most important infectious disease in the world. A major barrier to tuberculosis control is poor adherence to long-term and complex treatment regimens.\n\nThis is a multicenter prospective, non-inferiority randomized controlled study. The purpose of our study is a) to evaluate the tolerability, efficacy and pharmacokinetics\u002Fpharmacodynamics (PK\u002FPD) of the high-dose rifapentine, b) to evaluate whether the high-dose rifapentine-containing regimen has the potential to treat the rifampicin-sensitive pulmonary tuberculosis and shorten the course of treatment to 17 weeks. This study is of great significance for shortening the course of treatment, reducing the adverse reactions and economic burden of patients' treatment in rifampicin-sensitive tuberculosis patient.",[165],"Tuberculosis, Pulmonary",[167,168,169],"rifapentine","shorter treatment","pulmonary tuberculosis","2023-12-08",{"date":172,"type":173},"2023-12-11","ACTUAL",{"date":175,"type":173},"2023-01-13",{"date":177,"type":158},"2027-11-01",{"name":5,"class":6},6]