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Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Summary
A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB). A5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care \[(SOC) isoniazid/rifampicin/pyrazinamide/ethambutol (HRZE)\]. The study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of experimental or SOC treatment (based on treatment arm assignment) followed by 18 weeks of SOC treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.
Official title: A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
315
Start Date
2025-03-11
Completion Date
2027-08-11
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
Isoniazid
INH 300 mg will be administered as one tablet orally once daily.
Rifampicin
RIF 600 mg will be administered as two 300 mg capsules orally once daily on an empty stomach, 1 hour before or 2 hours after eating a meal.
Pyrazinamide
PZA will be administered as 500 mg tablets, based on weight, orally once daily.
Ethambutol
EMB will be administered as 400 mg tablets, based on weight, orally once daily.
Bedaquiline
BDQ 400 mg will be administered as four 100 mg tablets orally once daily with a meal for the first 2 weeks followed by 200 mg (two 100 mg tablets) orally once daily with a meal for 6 weeks.
Pretomanid
Pa 200 mg will be administered as one 200 mg tablet orally once daily with a meal.
Linezolid
LZD 600 mg will be administered as one 600 mg tablet orally once daily.
TBI-223
TBI-223 2400 mg once daily will be administered as four 600 mg tablets orally once daily with a meal.
Sutezolid
SZD 1600 mg once daily will be administered as four 400 mg tablets orally once daily with a meal.
TBI-223
TBI-223 1200 mg once daily will be administered as two 600 mg tablets orally with a meal.
Sutezolid
SZD 800 mg once daily will be administered as two 400 mg tablets orally once daily with a meal.
Locations (28)
12701, Gaborone CRS
Gaborone, Botswana
12201, Hospital Nossa Senhora da Conceicao CRS
Porto Alegre, Brazil
12101, Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, Brazil
30022, Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
Port-au-Prince, Haiti
31730, GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS
Port-au-Prince, Haiti
31441, Byramjee Jeejeebhoy Medical College (BJMC) CRS
Pune, India
12601, Moi University Clinical Research Center (MUCRC) CRS
Eldoret, Kenya
12501, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS
Kericho, Kenya
30301, Blantyre CRS
Blantyre, Malawi
12001, Malawi CRS
Lilongwe, Malawi
32078, Nutrición-Mexico CRS
Mexico City, Mexico
11301, Barranco CRS
Lima, Peru
31985, Socios En Salud Sucursal Perú CRS
Lima, Peru
31981, TB HIV Innovations and Clinical Research Foundation Corp.
Cavite, Philippines
31793, South African Tuberculosis Vaccine Initiative (SATVI) CRS
Cape Town, South Africa
31792, University of Cape Town Lung Institute (UCTLI) CRS
Cape Town, South Africa
31422, CAPRISA eThekwini CRS
Durban, South Africa
11201, Durban International CRS
Durban, South Africa
12301, Soweto ACTG CRS
Johannesburg, South Africa
11101, University of the Witwatersrand Helen Joseph (WITS HJH) CRS
Johannesburg, South Africa
31684, Rustenburg CRS
Rustenburg, South Africa
31784, Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
Chiang Mai, Thailand
5116 Chiangrai Prachanukroh Hospital NICHD CRS
Chiang Rai, Thailand
31802, Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
Pathum Wan, Thailand
12401, Joint Clinical Research Centre (JCRC)/Kampala CRS
Kampala, Uganda
30293 MU-JHU Research Collaboration (MUJHU CARE LTD) CRS
Kampala, Uganda
32483 National Lung Hospital CRS
Hanoi, Vietnam
30313, Milton Park CRS
Harare, Zimbabwe