A Pan-TB Regimen Targeting Host and Microbe

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

352

Participants

Timeline

Start Date

July 28, 2023

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Tuberculosis
Interventions
DRUG

Sutezolid

Sutezolid will be given at a dose of 1200mg QD in arm 1 and at a dose of 1600mg QD in arms 2 and 3.

DRUG

N-acetyl cysteine

NAC will be given at a dose of 1800 mg BID in arm 3

DRUG

Pretomanid

Pretomanid will be given at its approved dose

DRUG

Bedaquiline

Bedaquiline will be given at its approved dose

COMBINATION_PRODUCT

Rifafour

Fixed dose combination tablets for TB treatment will be given at approved doses

Trial Locations (8)

1632

The Aurum Institute: Tembisa Clinical Research Centre, Tembisa

2092

Clinical HIV Research Unit, Johannesburg

2571

The Aurum Institute, Gavin J Churchyard Legacy Centre (Klerksdorp Clinical Research Centre), Klerksdorp

4015

Clinical HIV Research Unit, Durban

6529

TASK Eden, George

Unknown

Instituto Nacional de Saúde, Maputo

NIMR-Mbeya Medical Research Centre, Mbeya

0299

The Aurum Institute, Rustenburg Clinical Research Centre, Rustenburg

All Listed Sponsors
collaborator

Ludwig-Maximilians - University of Munich

OTHER

collaborator

Stichting Katholieke Universiteit

OTHER

collaborator

Wits Health Consortium (Pty) Ltd

OTHER

collaborator

Instituto Nacional de Saúde, Mozambique

OTHER_GOV

collaborator

National Institute for Medical Research, Tanzania

OTHER_GOV

collaborator

University of Stellenbosch

OTHER

collaborator

Sequella, Inc.

INDUSTRY

collaborator

Global Alliance for TB Drug Development

OTHER

lead

The Aurum Institute NPC

OTHER