panTB-HM: a multi-arm clinical trial of a pan-TB regimen targeting both host and microbe.

BACKGROUND: Newer oxazolidinones will be required to advance regimens in pan-TB indications. The addition of host-directed agents may help promote the recovery of lung function during TB treatment and prevent post-TB lung disease.

METHODS: The panTB-HM trial assesses the capacity of three novel regimens containing the oxazolidinone sutezolid and the antioxidant N-acetylcysteine (NAC) to meet the target criteria proposed by WHO for pan-TB indications (including use without rifamycin susceptibility testing and of 4 months or less duration) in a phase 2C trial.

DISCUSSION: This trial is ground-breaking in its objectives and design for a 4-month pan-TB indication (in a non-inferiority comparison to standard treatment) and its evaluation of lung function recovery (in a superiority comparison).

TRIAL REGISTRATION: ClinicalTrials.gov NCT05686356. Registered on 13 Jan 2023.