PROJECT

Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of Bedaqualine, Delamanid, Clofazimine, Linezolid for Treatment of Children/Adolescents with DR-TB

August 2024 - September 2027

Objectives:

To evaluate the pharmacokinetics and anti-mycobacterial activity of Bedaqualine, Delamanid,
Clofazimine, Linezolid in children and adolescents (0 months to less than < 18 years of age)
diagnosed with confirmed or probable pulmonary drug resistant tuberculosis (DR-TB).

Study Overview:

This multicentre study will evaluate the pharmacokinetics, anti-mycobacterial activity, safety, and tolerability of newer anti-tuberculosis drugs—bedaquiline, delamanid, clofazimine, and linezolid—in children and adolescents with drug-resistant tuberculosis. Approximately 100 children will be recruited and followed while receiving age- and weight-appropriate treatment. Blood samples will be collected at multiple time points after drug administration to measure drug concentrations and determine key pharmacokinetic parameters.

Study Approach:

This is a prospective, multicentre study involving 100 children and adolescents with
confirmed or probable pulmonary DR-TB. Participants will receive age- and weight-
appropriate anti-TB treatment. At steady state, children will undergo intensive PK
assessment, with blood samples collected before drug administration and at 1, 2, 3, 4, 6, and 8
hours after dosing. Plasma concentrations of linezolid, clofazimine, and bedaquiline or
delamanid will be measured using validated laboratory methods, and pharmacokinetic
parameters will be determined.

Expected Public Health Impact:

This study will provide novel PK data for appropriate drug dosing recommendations for newer anti TB drugs to be used for treatment of DR-TB in children and adolescent