Phase 2 Trial Assessing TBAJ876 or Bedaquiline, with Pretomanid and Linezolid in Adults with Drug-sensitive Pulmonary Tuberculosis

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

309

Participants

Timeline

Start Date

October 24, 2023

Primary Completion Date

December 27, 2024

Study Completion Date

June 30, 2026

Conditions
Pulmonary TBPulmonary TuberculosisDrug Sensitive Tuberculosis
Interventions
DRUG

TBAJ-876

tablet

DRUG

Pretomanid

200 mg

DRUG

Linezolid

600 mg

DRUG

Bedaquiline

200 mg for 8 weeks followed by 100 mg for 18 weeks

DRUG

HRZE

Isoniazid (H) + rifampicin (R) + pyrazinamide (Z) plus ethambutol (E) fixed dose combination tablets dosed by weight

DRUG

HR

Isoniazid (H) + rifampicin (R) fixed dose combination tablets dosed by weight

Trial Locations (22)

1104

Lung Center of the Philippines, Quezon City

1230

Tropical Disease Foundation, Makati City

2092

WITS, Clinical HIV Research Unit (CHRU) Themba Lethu Clinic, Helen Joseph Hospital, Johannesburg

2571

Perinatal HIV Research Unit (PHRU), Klerksdorp

2999

The Aurum Institute, Rustenburg

3610

TB and HIV Investigative Network (THINK), Hillcrest

4052

Enhancing Care Foundation, Durban

4114

Care Clinical Trial Group Inc., Dasmariñas

5201

Synergy Biomed Research Institute (SBRI), East London

6200

Isango Lethemba TB Research Unit, Port Elizabeth

6529

TASK Eden, George

7405

TASK Brooklyn, Cape Town

7700

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

7750

Desmond Tutu Health Foundation, Cape Town

0101

National Center for Tuberculosis and Lung Diseases, Tbilisi

0152

Setshaba Research Centre, Soshanguve

0250

Madibeng Centre for Research, Brits

Unknown

NIMR-MBEYA Medical Research Center, Mbeya

Kilimanjaro Christian Medical Centre, Moshi

National Institute for Medical Research (NIMR), Mwanza

Case Western Reserve University- Research collaboration Uganda, Kampala

Joint Clinical Research Centre (JCRC), Kampala

All Listed Sponsors
lead

Global Alliance for TB Drug Development

OTHER

NCT06058299 - Phase 2 Trial Assessing TBAJ876 or Bedaquiline, with Pretomanid and Linezolid in Adults with Drug-sensitive Pulmonary Tuberculosis | Biotech Hunter | Biotech Hunter