The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent to the adult dose already shown to be effective against multidrug-resistant tuberculosis.
This trial will investigate the pharmacokinetics (PK) and safety of delamanid administered for 10 days to pediatric patients aged birth to 17 years who are also on therapy with an optimized background regimen. The purpose of the trial is to determine which dose in pediatric MDR-TB patients will result in delamanid plasma exposure similar to efficacious plasma exposure in adult MDR-TB patients. This is an age de-escalation trial in four groups: Group 1: 12 to 17 years (100 mg BID; n=6) Group 2: 6 to 11 years (50 mg BID; n=6) Group 3: 3 to 5 years (25 mg BID; n=12) Group 4: Birth to 2 years (Dose based on patient's body weight, n=12) * Patients \> 10 kg will receive 10 mg BID * Patients \> 8 kg and ≤ 10 kg will receive 5 mg BID * Patient ≤ to 8 kg will receive 5 mg QD
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
100 mg Delamanid BID for 10 days
50 mg Delamanid BID for 10 days
25 mg Pediatric Formulation Delamanid BID for 10 days
De La Salle Health Sciences Institute
Dasmariñas, Cavite, Philippines
Brooklyn Chest Hospital
Ysterplaat, Cape Town, South Africa
Plasma Concentrations
Plasma concentrations (Cmax, tmax, AUC 0-24h, accumulation ratio, apparent terminal elimination half-life, apparent total clearance) of delamanid and its metabolites on Days 1, 2, 10, 11, 13 (Groups 1 and 2 only), 15, 18.
Time frame: Days 1, 2, 10, 11, 13 (Groups 1 and 2 only), 15, 18
Adverse Events
Number of reported adverse events
Time frame: 40 Days
Safety Summary
Summary statistics of subjects with clinically significant abnormal laboratory test results, vitals, ECGs
Time frame: 40 Days
Palatability of the Pediatric Formulation
Palatability of the pediatric formulation will be assessed using an age-appropriate visual hedonic scale and clinical assessment for Groups 3 and 4 only.
Time frame: Days 1 and 10
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Patients \> 10 kg will receive DPF 10 mg BID for 10 days
Patients \> 8 kg and ≤ 10 kg will receive DPF 5 mg BID for 10 days Patients ≤ 8 kg will receive DPF 5 mg QD for 10 days
Selection and administration of the treatment medications (i.e. OBRs) will be based on WHO's Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country