Clinical Trial

A Pan-TB Regimen Targeting Host and Microbe

Study acronym: panTB-HM
Active, Not Recruiting Phase 2/3
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Record status
This record was last updated May 28, 2025 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-01-13; most recent amendment 2025-05-22.
Status change: Recruiting → Active, Not Recruiting 2025-05-22
Status change: Not Yet Recruiting → Recruiting 2023-08-14
Trial Details
NCT Number NCT05686356
Lead Sponsor The Aurum Institute NPC
Collaborators: Ludwig-Maximilians - University of Munich, Stichting Katholieke Universiteit, Wits Health Consortium (Pty) Ltd, Instituto Nacional de Saúde, Mozambique, National Institute for Medical Research, Tanzania, University of Stellenbosch, Sequella, Inc., Global Alliance for TB Drug Development
Conditions Tuberculosis
Enrollment 352 participants
Start Date 2023-07-28
Primary Completion 2026-01 (estimated)
Study Completion 2026-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-28