Overview

A Pan-TB Regimen Targeting Host and Microbe

Status:
Not yet recruiting
Trial end date:
2025-09-30
Target enrollment:
Participant gender:
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).
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
The Aurum Institute NPC
Collaborators:
Global Alliance for TB Drug Development
Instituto Nacional de Saúde, Mozambique
Ludwig-Maximilians - University of Munich
National Institute for Medical Research, Tanzania
Sequella, Inc.
Stichting Katholieke Universiteit
University of Stellenbosch
Wits Health Consortium (Pty) Ltd
Treatments:
Acetylcysteine
Bedaquiline
N-monoacetylcystine