Pharmacokinetics and safety of high-dose rifampicin in children with TB: the Opti-Rif trial.

ABSTRACT:

Background

Rifampicin doses of 40 mg/kg in adults are safe and well tolerated, may shorten anti-TB treatment and improve outcomes, but have not been evaluated in children.

Objectives

To characterize the pharmacokinetics and safety of high rifampicin doses in children with drug-susceptible TB.

Patients and methods

The Opti-Rif trial enrolled dosing cohorts of 20 children aged 0-12 years, with incremental dose escalation with each subsequent cohort, until achievement of target exposures or safety concerns. Cohort 1 opened with a rifampicin dose of 15 mg/kg for 14 days, with a single higher dose (35 mg/kg) on day 15. Pharmacokinetic data from days 14 and 15 were analysed using population modelling and safety data reviewed. Incrementally increased rifampicin doses for the

SUBMITTER: Garcia-Prats AJ 

PROVIDER: S-EPMC8598292 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature