5,832
Participants
Start Date
June 3, 2019
Primary Completion Date
January 11, 2027
Study Completion Date
January 11, 2027
Delamanid (DLM)
"Adults and children ≥30 kg: delamanid 200 mg orally once daily.~Children ≥2.5 kg to \<30 kg: weight-band dosing orally once daily as per the study protocol. As children gain weight, their DLM dose should be adjusted, typically every month or as the visit schedule permits."
Isoniazid (INH)
"Adults and children ≥24 kg: INH 300 mg orally once daily.~Children ≥2.5 kg to \<24 kg: INH weight-band dosing orally once daily as per the study protocol. As children gain weight, their INH dose should be adjusted."
Pyridoxine (vitamin B6)
All HHCs in Arm B must receive pyridoxine (vitamin B6) with each dose of INH based on the current local dosing guidelines. For children up to 3 years of age and nursing women, pyridoxine will be given as per local standard of care. Pyridoxine is not supplied through the study.
Soweto ACTG CRS, Johannesburg
Wits Helen Joseph Hospital CRS (Wits HJH CRS), Johannesburg
PHRU Matlosana CRS, Klerksdorp
CAPRISA eThekwini CRS, Durban
Durban International Clinical Research Site CRS, Durban
De La Salle Health Science Institute Angelo King Medical Research Center (DLSHSI-AKMRC), Cavite
Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS, Cape Town
Task Applied Science (TASK) CRS, Cape Town
University of Cape Town Lung Institute (UCTLI) CRS, Cape Town
South African Tuberculosis Vaccine Initiative (SATVI) CRS, Cape Town
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS, Pathum Wan
Siriraj Hospital ,Mahidol University NICHD CRS, Bangkok
Socios En Salud Sucursal Perú CRS, Lima
Barranco CRS, Lima
Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS, Kericho
Moi University Clinical Research Center (MUCRC) CRS, Eldoret
Chiangrai Prachanukroh Hospital NICHD CRS, Chiang Mai
Vietnam-University of Sydney CRS Site# 32495, Hochiminh City
National Lung Hospital CRS (Site ID: 32483), Vĩnh Phúc
Byramjee Jeejeebhoy Medical College (BJMC) CRS, Pune
YRG CARE CRS [Site ID: 32075], Chennai
Gaborone CRS, Gaborone
Kilimanjaro Christian Medical Centre (KCMC), Moshi
Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site, Kampala
MU-JHU Research Collaboration (MUJHU CARE LTD) CRS, Kampala
Milton Park CRS, Milton Park
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS, Rio de Janeiro
GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS, Port-au-Prince
Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS, Port-au-Prince
San Miguel CRS, Lima
Rustenburg CRS, Rustenburg
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH