[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100485146":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":41,"locations":50,"responsibleParty":66,"collaborators":27,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":27,"enrollmentInfo":79,"targetDuration":27,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":27,"overallStatus":53,"whyStopped":27,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Institute of Tropical Medicine, Belgium","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"BE-PEP","EXPERIMENTAL","Intervention arm in which BE-PEP will be provided to all persons residing within 100 meters of an index case, to be repeated after four weeks for household contacts.\n\nBE-PEP: bedaquiline (400 or 800 mg depending on weight band) combined with rifampicin (10 mg\u002Fkg) will be provided as post-exposure prophylaxis\n\nBoth arms will target anyone living within 100 meters of an index case or the entire village if more than 50% are eligible. The dosage form of rifampicine is 150 mg and 300 mg, for bedaquiline it's 20 mg or 100 mg.",[13,14],"Drug: BE-PEP Bedaquiline","Drug: BE-PEP Rifampicin",{"label":16,"type":17,"description":18,"interventionNames":19},"SDR PEP","ACTIVE_COMPARATOR","WHO recommended standard PEP will be provided, i.e. 10 mg\u002Fkg of rifampicin in a single dose. In both arms anyone living within 100 meters of an index case will be targeted or the entire village if more than 50% are eligible.\n\nThe dosage form of rifampicine is 150 mg and 300 mg.",[20],"Drug: SDR-PEP Rifampicin",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","BE-PEP Bedaquiline","bedaquiline",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"SDR-PEP Rifampicin","SDR-PEP: rifampicin",[16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"BE-PEP Rifampicin","BE-PEP rifampicin",[9],[37],{"name":38,"affiliation":39,"role":40},"Younoussa Assoumani","Damien Foundation Comoros","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":27,"email":46},"Carolien Hoof","CONTACT","+32(0)32470716","choof@itg.be",{"name":48,"role":44,"phone":27,"phoneExt":27,"email":49},"Natacha Herssens","nherssens@itg.be",[51],{"facility":52,"status":53,"city":54,"state":27,"zip":27,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Fondation Damien","RECRUITING","Moroni","Comoros","KM",{"type":58,"coordinates":59},"Point",[60,61],43.25506,-11.70216,{"lat":61,"lon":60},[64],{"name":38,"role":44,"phone":27,"phoneExt":27,"email":65},"yaoussaoumani@gmail.com",{"type":67,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100485146","phase-3-bedaquiline-enhanced-post-exposure-prophylaxis-for-leprosy-100485146",false,"NCT05597280","Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy","Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy: Phase 3 Study","BE-PEOPLE P3","Inclusion Criteria:\n\n1. Living in one of the study clusters (34 on Anjouan, 10 on Mohéli), in good state of health\n2. Aged 2 years and above, as leprosy is very rare among infants and young toddlers. Children age 2-4 years or weighing less than 20 kg will not be given bedaquiline. If eligible they will receive only rifampicin.\n3. Able and willing to provide informed consent for leprosy and tuberculosis screening, and PEP administration (as applicable in the different arms)\n\nExclusion Criteria:\n\n1. Signs of active leprosy\n2. Signs of active pulmonary tuberculosis (cough ≥2 weeks duration and without a negative TB test)\n3. Signs of active extra-pulmonary tuberculosis (bluish-red nodules that cover the lymph nodes, bones or joints, or cervical glands with discharge)\n4. Having received rifampicin or bedaquiline (if applicable) in the last 2-year period\n5. Self-reported (suspected) pregnancy or breastfeeding\n6. Concurrent (within the last three week period before D0) use of medications not included in the safe list (for bedaquiline only)",true,"ALL","2 Years",{"count":80,"type":81},124000,"ESTIMATED","INTERVENTIONAL",[84],"PHASE3","There will be two study arms. Arm 1 will be the intervention arm in which there will be provided BE-PEP to all persons residing within 100 meters of an index case, to be repeated after four weeks for household contacts. Arm 2 will be the comparator arm in which the WHO recommended standard PEP will be provided, i.e. 10 mg\u002Fkg of rifampicin in a single dose. In both arms the investigators will target anyone living within 100 meters of an index case or the entire village if more than 50% are eligible. Provision of BE-PEP will start in 2023 and follow-up will continue until 2026. The main study outcome will be the comparison of leprosy risk in individuals that received BE-PEOPLE standard WHO SDR-PEP versus individuals that received BE-PEP. In addition the investigators will compare the overall leprosy incidence over the follow-up period between the two study arms.",[87],"Leprosy","2026-05-18",{"date":90,"type":91},"2026-05-19","ACTUAL",{"date":93,"type":91},"2023-03-22",{"date":95,"type":81},"2027-03-15",{"name":5,"class":6},1]