Phase 2 Study of Bedaquiline TMC207 with Background MDR-TB Medications to Treat Children and Adolescents Aged 0 Months to Under 18 Years with Pulmonary Multidrug-Resistant Tuberculosis

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and anti-mycobacterial activity of bedaquiline TMC207 combined with a standard background regimen of medications in children and adolescents aged from birth up to less than 18 years who have confirmed or probable pulmonary multidrug resistant tuberculosis MDR-TB. This phase 2 study aims to better understand how the drug works in this population and assess its effects alongside other MDR-TB treatments. Participants are grouped into four age-based cohorts, each receiving a dose of bedaquiline adjusted for their age and weight. Cohorts 1 and 2 include older children and adolescents who start with daily dosing for two weeks followed by three times weekly dosing for 22 weeks. Younger children in Cohorts 3 and 4 receive weight-based doses with similar schedules. All participants take bedaquiline along with a background regimen of MDR-TB medications according to WHO and national guidelines. During the study, participants undergo regular monitoring of drug levels in their blood at various weeks up to 120 weeks for older cohorts and 88 weeks for the youngest cohort. Researchers also track adverse events, treatment outcomes, and time to culture conversion from clinical samples. The study involves long-term follow-up to evaluate safety, drug behavior, and treatment success over time.

Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/Adolescents With Pulmonary MDR-TB