Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

PHASE2RecruitingINTERVENTIONAL
Enrollment

315

Participants

Timeline

Start Date

March 11, 2025

Primary Completion Date

March 11, 2026

Study Completion Date

March 11, 2027

Conditions
Pulmonary Tuberculosis
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.

Trial Locations (27)

265

NOT_YET_RECRUITING

30301, Blantyre CRS, Blantyre

1010

NOT_YET_RECRUITING

11301, Barranco CRS, Lima

1864

NOT_YET_RECRUITING

12301, Soweto ACTG CRS, Johannesburg

2193

NOT_YET_RECRUITING

11101, University of the Witwatersrand Helen Joseph (WITS HJH) CRS, Johannesburg

4091

NOT_YET_RECRUITING

11201, Durban International CRS, Durban

4114

NOT_YET_RECRUITING

31981, TB HIV Innovations and Clinical Research Foundation Corp., Cavite

6110

NOT_YET_RECRUITING

30022, Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS, Port-au-Prince

NOT_YET_RECRUITING

31730, GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS, Port-au-Prince

6850

RECRUITING

31793, South African Tuberculosis Vaccine Initiative (SATVI) CRS, Cape Town

7700

NOT_YET_RECRUITING

31792, University of Cape Town Lung Institute (UCTLI) CRS, Cape Town

10005

NOT_YET_RECRUITING

12401, Joint Clinical Research Centre (JCRC)/Kampala CRS, Kampala

10330

NOT_YET_RECRUITING

31802, Thai Red Cross AIDS Research Centre (TRC-ARC) CRS, Pathum Wan

14080

NOT_YET_RECRUITING

32078, Nutrición-Mexico CRS, Mexico City

15046

NOT_YET_RECRUITING

31985, Socios En Salud Sucursal Perú CRS, Lima

20200

RECRUITING

12501, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS, Kericho

21040

RECRUITING

12101, Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS, Rio de Janeiro

30100

NOT_YET_RECRUITING

12601, Moi University Clinical Research Center (MUCRC) CRS, Eldoret

30313

NOT_YET_RECRUITING

30313, Milton Park CRS, Harare

40001

NOT_YET_RECRUITING

31422, CAPRISA eThekwini CRS, Durban

50200

NOT_YET_RECRUITING

31784, Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS, Chiang Mai

57000

NOT_YET_RECRUITING

5116 Chiangrai Prachanukroh Hospital NICHD CRS, Chiang Rai

91350

NOT_YET_RECRUITING

12201, Hospital Nossa Senhora da Conceicao CRS, Porto Alegre

100000

NOT_YET_RECRUITING

32483 National Lung Hospital CRS, Hanoi

411001

NOT_YET_RECRUITING

31441, Byramjee Jeejeebhoy Medical College (BJMC) CRS, Pune

0000

NOT_YET_RECRUITING

12701, Gaborone CRS, Gaborone

A-104

NOT_YET_RECRUITING

12001, Malawi CRS, Lilongwe

Unknown

RECRUITING

31684, Rustenburg CRS, Rustenburg

All Listed Sponsors
collaborator

TB Alliance

UNKNOWN

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH