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A Pan-TB Regimen Targeting Host and Microbe

Study acronym: panTB-HM
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Sep 30, 2025 to Jan 2026
    • Site details revised at 8 of 8 sites
    v7
  2. Site details revised at 8 of 8 sitesv6
  3. Site contacts updated at 1 of 8 sitesv5
  4. Study sites: 5 to 8v4
  5. Site contacts updated at 1 of 5 sitesv3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2023 to Jul 28, 2023
    • Study sites: 4 to 5
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
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
(from sponsor)		 Tuberculosis
Related terms Tuberculosis
Enrollment 352 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov