Paediatric study of bedaquiline remains an “open issue”

In their editorial, "Bedaquiline and multidrug-resistant tuberculosis: a systematic and critical analysis of the evidence", Pontali et al . [1] detail and analyse the existing evidence for bedaquiline for multidrug-resistant tuberculosis (MDR-TB). The authors also discuss "open issues" or areas where additional research is required to inform use, including in children. Pontali et al . [1] mention the planned phase II paediatric study of bedaquiline ([www.clinicaltrials.gov][1] identifier number NCT 02354014). This study to evaluate the pharmacokinetics and safety of bedaquiline in children is crucial to guiding treatment in people under 18 years of age, who have previously been excluded from trials of bedaquiline. Paediatric study of bedaquiline is open but several years behind schedule, delaying access for children with MDR-TB [1]: http://www.clinicaltrials.gov