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A Pan-TB Regimen Targeting Host and Microbe
Sponsor: The Aurum Institute NPC
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
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.
N-acetyl cysteine
NAC will be given at a dose of 1800 mg BID in arm 3
Pretomanid
Pretomanid will be given at its approved dose
Bedaquiline
Bedaquiline will be given at its approved dose
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