NCT05686356

A Pan-TB Regimen Targeting Host and Microbe

A Novel 4-month Pan-TB Regimen Targeting Both Host and Microbe (panTB-HM)

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 352 (estimated)
• Sponsor: The Aurum Institute NPC · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DRUG	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.
DRUG	N-acetyl cysteine	NAC will be given at a dose of 1800 mg BID in arm 3
DRUG	Pretomanid	Pretomanid will be given at its approved dose
DRUG	Bedaquiline	Bedaquiline will be given at its approved dose
COMBINATION_PRODUCT	Rifafour	Fixed dose combination tablets for TB treatment will be given at approved doses

Timeline

• Start date: 2023-07-28
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2023-01-17
• Last updated: 2025-05-28

Locations

8 sites across 3 countries: Mozambique, South Africa, Tanzania