Table 8.
Ongoing trials testing delamanid pharmakokinetic in children (0–18 years) with MDR-TB.
| Title | Study Design | Target Population | Intervention | Outcome Measures |
|---|---|---|---|---|
| A 6-Month Safety, Efficacy, and pharmacokinetic Trial of Delamanid in Pediatric Patients With MDR-TB (NCT01859923) |
Phase 2, Open-label, Multiple-dose Trial | Children and adolescents who have confirmed or probable pulmonary MDR-TB enrolled in 4 age-based cohorts: (1) 12 to 17 years (2) 6 to 11 years (3) 3 to 5 years (4) 0 to 2 years |
Group 1: Delamanid 100 mg td for 182 days + BR for 365 days Group 2: Delamanid 50 mg td for 182 days + BR for 365 days Group 3: Delamanid 25 mg (pediatric formulation) td for 182 days + BR for 365 days Cohort 4: Delamanid from 5 mg qd to 10 mg td (pediatric formulation) based on weight measurements for 182 days + BR for 365 days |
Pharmacokinetic, safety, tolerability, and efficacy of delamanid |
| Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients with MDR-TB (NCT01856634) |
Phase 1, Open-label, Multiple-dose, and Age De-escalation Trial | Children and adolescents who have confirmed or probable pulmonary MDR-TB enrolled in 4 age-based cohorts: (1) 12 to 17 years (2) 6 to 11 years (3) 3 to 5 years (4) 0 to 2 years |
Group 1: Delamanid 100 mg td + BR for 10 days Group 2: Delamanid 50 mg td + BR for 10 days Group 3: Delamanid 25 mg (pediatric formulation) td + BR for 10 days Cohort 4: Delamanid from 5 mg to 10 mg td (pediatric formulation) based on weight measurements + BR for 10 days |
Pharmacokinetics, Safety and Tolerability of Delamanid |
| Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen for MDR-TB in HIV-Infected and HIV-Uninfected Children With MDR-TB (NCT03141060) |
Phase I/II Open-Label, Single-Arm Study | Children and adolescents who have MDR-TB with and without HIV-infection, enrolled in 4 age-based cohorts: (1) 12 to 17 years (2) 6 to 11 years (3) 3 to 5 years (4) 0 to 2 years |
Delamanid for 24 weeks + BR, dose based on age group and weight | Pharmacokinetics, Safety, and Tolerability of Delamanid |
BR, background regimen; MDR, multidrug-resistant; qd:, once daily; TB, tuberculosis.