drugset / Trial / NCT05686356
A Pan-TB Regimen Targeting Host and Microbe
Phase 2/3
Active not recruiting
352 enrolled
The Aurum Institute NPC
Global Alliance for TB Drug Development · collabInstituto Nacional de Saúde, Mozambique · collabLudwig-Maximilians - University of Munich · collabNational Institute for Medical Research, Tanzania · collabSequella, Inc. · collabStichting Katholieke Universiteit · collabUniversity of Stellenbosch · collabWits Health Consortium (Pty) Ltd · collab
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2023-07-28
- Primary completion
- 2026-01
- Completion
- 2026-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | — | — |
| Subject | N-acetylcysteine | Small molecule | 1800 mg | — |
| Subject | Pretomanid | Small molecule | — | — |
| Subject | Rifafour | Unknown | — | — |
| Subject | Sutezolid | Small molecule | 1200 mg | — |
| Subject | Sutezolid | Small molecule | 1600 mg | — |