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ACTIVE NOT RECRUITING
NCT05686356
PHASE2/PHASE3

A Pan-TB Regimen Targeting Host and Microbe

Sponsor: The Aurum Institute NPC

View on ClinicalTrials.gov

Summary

This project will develop the first regimen meeting WHO criteria for a pan-TB indication, ie, not requiring knowledge of RIF susceptibility. The regimen will test sutezolid at 2 dose levels, with the approved anti-TB drugs bedaquiline and pretomanid, in a phase 2c trial. It will also test whether the addition of N-acetylcysteine (NAC), a re-purposed host-directed WHO essential medicine, can protect the lung and liver against oxidative damage, preserve lung function, and accelerate the eradication of MTB infection by replenishing glutathione (GSH).

Official title: A Novel 4-month Pan-TB Regimen Targeting Both Host and Microbe (panTB-HM)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

352

Start Date

2023-07-28

Completion Date

2026-01

Last Updated

2025-05-28

Healthy Volunteers

No

Conditions

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

Locations (8)

Instituto Nacional de Saúde

Maputo, Mozambique

Clinical HIV Research Unit

Durban, Durban, South Africa

Clinical HIV Research Unit

Johannesburg, Gauteng, South Africa

The Aurum Institute: Tembisa Clinical Research Centre

Tembisa, Gauteng, South Africa

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

Klerksdorp, Klerksdorp, South Africa

The Aurum Institute, Rustenburg Clinical Research Centre

Rustenburg, North West Provice, South Africa

TASK Eden

George, Western Cape, South Africa

NIMR-Mbeya Medical Research Centre

Mbeya, Tanzania