Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06192160
PHASE2

Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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

Interventions

DRUG

Isoniazid

INH 300 mg will be administered as one tablet orally once daily.

DRUG

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.

DRUG

Pyrazinamide

PZA will be administered as 500 mg tablets, based on weight, orally once daily.

DRUG

Ethambutol

EMB will be administered as 400 mg tablets, based on weight, orally once daily.

DRUG

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.

DRUG

Pretomanid

Pa 200 mg will be administered as one 200 mg tablet orally once daily with a meal.

DRUG

Linezolid

LZD 600 mg will be administered as one 600 mg tablet orally once daily.

DRUG

TBI-223

TBI-223 2400 mg once daily will be administered as four 600 mg tablets orally once daily with a meal.

DRUG

Sutezolid

SZD 1600 mg once daily will be administered as four 400 mg tablets orally once daily with a meal.

DRUG

TBI-223

TBI-223 1200 mg once daily will be administered as two 600 mg tablets orally with a meal.

DRUG

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