IMPAACT P1108 Informs WHO TB Management Recommendation

The IMPAACT P1108 study team is delighted to share that data from IMPAACT P1108 have informed the World Health Organization (WHO) recommendation for use of bedaquiline (BDQ) in children aged below six years, released in the WHO’s “Rapid Communication on updated guidance on the management of tuberculosis in children and adolescents”, published on 23 August 2021. This recommendation comes following review of pharmacokinetics (PK) and safety data by a WHO-convened Guideline Development Group meeting.   

P1108 is a Phase I/II, open-label, single-arm, exposure-controlled dose-finding modified age de-escalation study of BDQ in infants, children, and adolescents living with and without HIV, with clinically diagnosed or confirmed multidrug-resistant tuberculosis. The study is designed to evaluate the PK, safety, and tolerability of BDQ over 24 weeks from the initiation of study treatment.