[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100399740":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":29,"locations":46,"responsibleParty":58,"collaborators":60,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":29,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":106,"whyStopped":29,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 (Conventional treatment group)","ACTIVE_COMPARATOR","Will be treated as recommended by Korean Guidelines For Tuberculosis as well as WHO guidelines (e.g. isoniazid, rifampicin, ethambutol, and pyrazinamide for 2 months followed by isoniazid, rifampicin, (and ethambutol)) Duration of the treatment\n\n\\- 6 months in total",[13,14,15,16],"Drug: Isoniazid","Drug: Pyrazinamide","Drug: Ethambutol","Drug: Rifampicin",{"label":18,"type":19,"description":20,"interventionNames":21},"Arm 2 (High-dose rifampicin group)","EXPERIMENTAL","High-dose rifampicin, isoniazid, and pyrazinamide\n\n* Rifampicin: 30mg\u002Fkg\n* Isoniazid: 300mg\u002Fday\n* Pyrazinamide: 1000mg\u002Fday (\\\u003C50kg), 1500mg\u002Fday (50-70kg), 2000mg \u002Fday (\\>70kg), till culture conversion Duration of the treatment\n* Till 12 weeks after culture conversion on liquid media",[22,13,14],"Drug: High-dose rifampicin",[24,30,34,38,42],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","High-dose rifampicin","30mg\u002Fkg",[18],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Isoniazid","300mg",[9,18],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Pyrazinamide","20-30mg\u002Fkg",[9,18],{"type":25,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"Ethambutol","15-20mg\u002Fkg",[9],{"type":25,"name":43,"description":44,"armGroupLabels":45,"otherNames":29},"Rifampicin","10mg\u002Fkg",[9],[47],{"facility":48,"status":29,"city":49,"state":29,"zip":50,"country":51,"countryCode":29,"cosmosGeoPoint":52,"geoPoint":57,"contacts":29},"Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine","Seoul","110-744","South Korea",{"type":53,"coordinates":54},"Point",[55,56],126.9784,37.566,{"lat":56,"lon":55},{"type":59,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[61,63,65,67,69,71,73,75,77,79],{"name":62,"class":6},"Chonnam National University Hospital",{"name":64,"class":6},"National Medical Center, Seoul",{"name":66,"class":6},"Pusan National University Hospital",{"name":68,"class":6},"Pusan National University Yangsan Hospital",{"name":70,"class":6},"Seoul National University Bundang Hospital",{"name":72,"class":6},"SMG-SNU Boramae Medical Center",{"name":74,"class":6},"Severance Hospital",{"name":76,"class":6},"Korean Institute of Tuberculosis",{"name":78,"class":6},"International Tuberculosis Research Center",{"name":80,"class":81},"Korean Center for Disease Control and Prevention","OTHER_GOV","100399740","phase-3-treatment-shortening-of-drug-sensitive-pulmonary-tuberculosis-using-high-dose-rifampicin-hi-dori-3-100399740",false,"NCT04485156","Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)","Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin to 3 Months After Culture Conversion (Hi-DoRi-3): A Phase 3, Multicenter, Randomized, Open-label, Clinical Trial","Hi-DoRi-3","Inclusion Criteria:\n\n* Documented positivity by sputum Xpert MTB\u002FRIF assay\n* Administration of current tuberculosis therapy (if any) for no more than 7 days (≤7) at the time of enrolment.\n\nExclusion Criteria:\n\n* Negative on Xpert MTB\u002FRIF assay\n* Resistance to rifampicin as detected by an Xpert MTB\u002FRIF assay\n* Known resistance to isoniazid, rifampicin, or pyrazinamide\n* HIV positive\n* Cancer patient on anti-cancer chemotherapy\n* Uncontrolled DM\n* Chronic hepatitis, liver cirrhosis\n* Any contraindications of drugs to be used","ALL","19 Years","85 Years",{"count":94,"type":95},926,"ESTIMATED","INTERVENTIONAL",[98],"PHASE3","The purpose of this study is to investigate the effectiveness and safety of the regimen including high dose rifampicin for individualized duration (3 months after Culture Conversion) for the treatment of drug-sensitive pulmonary tuberculosis.",[101],"Tuberculosis, Pulmonary",[103,43,104,105],"Tuberculosis","Treatment","Shortening","NOT_YET_RECRUITING","2020-07-21",{"date":109,"type":110},"2020-07-24","ACTUAL",{"date":112,"type":95},"2020-09",{"date":114,"type":95},"2026-12",{"name":5,"class":6},1]