drugset / Trial / NCT05686356

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

EvaluationDrugModalityDoseRoute
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

Indications