PanACEA-SUDOCU-01 was a phase 2b clinical trial conducted at four locations in Tanzania and South Africa. The innovative study design allowed administration of a novel backbone of bedaquiline–delamanid–moxifloxacin alone and together with four sutezolid doses (ranging from 600 mg once daily to 800 mg twice daily) to 75 adults with drug-susceptible pulmonary tuberculosis for 12 weeks. Clinical, microbiological, and pharmacokinetic–pharmacodynamic modelling analyses showed that the regimen was safe and microbiologically effective at all doses. Relationships between sutezolid dose and plasma exposure (including a key active metabolite), and between exposure and bacteriological response were identified, but maximal effect plateaus were not reached within the evaluated dose range.
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(25)00213-0/fulltext