[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100382503":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":50,"responsibleParty":69,"collaborators":71,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":44,"maxAge":44,"enrollmentInfo":82,"targetDuration":44,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":53,"whyStopped":44,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Institute of Tropical Medicine, Belgium","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"6EH³R3Z","EXPERIMENTAL","(Rifampicin (R)\u002F Isoniazid (H) \u002F Pyrazinamide (Z)\u002FEthambutol (E)) 6-month high-dose treatment; New high-dose isoniazid \u002F high-dose rifampicin retreatment regimen (6EH³R3Z) - that includes triple-dose rifampicin (R3; 30 mg\u002Fkg), and triple-dose isoniazid (H3; 15 mg\u002Fkg), complemented with pyrazinamide (Z) and ethambutol (E).",[13],"Drug: 6EH³R³Z",{"label":15,"type":16,"description":17,"interventionNames":18},"6EHRZ","ACTIVE_COMPARATOR","Standard of care: 6-month 6RHZE regimen with dose combination tablets (one tablet: 150 mg R + 75 mg H + 400 mg Z + 275mg E)",[19],"Drug: 6EHRZ",[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","6EH³R³Z","A triple dose is defined as the triple of the routine dose used for a specific WHO weight band. Hence, the mg\u002Fkg within a weigh-band varies, as is the case in routine practice.\n\nDosing takings into consideration the fixed dose combination (FDC) tablets (one tablet: 150 mg R + 75 mg H + 400 mg Z + 275mg E). Dosage relies on tables with dosage by weight-bands used by WHO for the Cat. 1 regimen. The dosage used for the intensive phase of the Cat. 1 regimen applies for the whole treatment duration. A double dose of H and R is added to the recommended normal dose for adults (WHO,2003)",[9],[27,28,29],"Ethambutol; isoniazid; rifampicin; pyrazinamide","triple dose isoniazid","triple dose rifampicin",{"type":22,"name":15,"description":31,"armGroupLabels":32,"otherNames":33},"Recommended normal dose adults (WHO, 2003)\n\n* H: 5 (4-6) mg\u002Fkg\u002Fday\n* R: 10 (8-12) mg\u002Fkg\u002Fday\n* Z: 25 (20-30)mg\u002Fkg\u002Fday\n* E: 15 (15-18)mg\u002Fkg\u002Fday",[15],[27],[35],{"name":36,"affiliation":37,"role":38},"Sani Kadri","Ministry of Health, Niger","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Natacha Herssens, MSc","CONTACT","003232470778",null,"nherssens@itg.be",{"name":47,"role":42,"phone":48,"phoneExt":44,"email":49},"Tom Decroo, MD","003232470535","tdecroo@itg.be",[51],{"facility":52,"status":53,"city":54,"state":44,"zip":44,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Damien Foundation","RECRUITING","Niamey","Niger","NE",{"type":58,"coordinates":59},"Point",[60,61],2.1098,13.51366,{"lat":61,"lon":60},[64,68],{"name":65,"role":42,"phone":66,"phoneExt":44,"email":67},"Bassirou Souleymane","+227 94985157","bachirsoul@gmail.com",{"name":36,"role":38,"phone":44,"phoneExt":44,"email":44},{"type":70,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[72],{"name":52,"class":6},"100382503","phase-3-novel-triple-dose-tuberculosis-retreatment-regimen-100382503",false,"NCT04260477","Novel Triple-dose Tuberculosis Retreatment Regimen","Novel Triple-dose Tuberculosis Retreatment Regimen: How to Overcome Resistance Without Creating More in Niger","Tri-Do-Re","Inclusion Criteria:\n\n* All newly registered patients with smear-positive recurrent pulmonary TB\n* Adults as well as children (no age limit)\n* Able and willing to provide written informed consent\n* Added for stage 2: lives within 5 km of a health facility with a medical doctor\n\nExclusion Criteria:\n\n* All patients with TB initially resistant to rifampicin on Xpert MTB\u002FRIF testing\n* Patients transferred to a health facility not supported by the Damien Foundation\n* Patients previously enrolled in the trial, and with another episode of rifampicin-susceptible TB during the study period\n* Those with grade III elevation of liver function tests at baseline, or with clinically active liver disease at screening\n* Pregnant or breastfeeding woman\n* HIV co-infected patients requiring treatment with a protease inhibitor","ALL",{"count":83,"type":84},370,"ESTIMATED","INTERVENTIONAL",[87],"PHASE3","To determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent Tuberculosis (TB).",[90,91,92,93],"Multidrug-resistant Tuberculosis","Pulmonary Tuberculosis","Tuberculosis","Resistance to Tuberculostatic Drugs",[95,92,96,97,98,99],"rifampicin-susceptible-TB","first-line","TB relapse","TB treatment failure","high dose retreatment","2025-04-10",{"date":102,"type":103},"2025-04-13","ACTUAL",{"date":105,"type":103},"2021-03-01",{"date":107,"type":84},"2025-09",{"name":5,"class":6},1]