A Pan-TB Regimen Targeting Host and Microbe

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).

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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• Stichting Katholieke Universiteit

  collaborator OTHER

• Wits Health Consortium (Pty) Ltd

  collaborator OTHER

• Instituto Nacional de Saúde, Mozambique

  collaborator OTHER_GOV

• National Institute for Medical Research, Tanzania

  collaborator OTHER_GOV

• University of Stellenbosch

  collaborator OTHER

• Sequella, Inc.

  collaborator INDUSTRY

• Global Alliance for TB Drug Development

  collaborator OTHER

• The Aurum Institute NPC

  lead OTHER

Principal Investigators

• Professor Robert Wallis, MD · The Aurum Institute NPC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-28

Primary Completion

2026-01-31

Completion

2026-01-31

Countries

• Mozambique
• South Africa
• Tanzania

Study Locations