Tafenoquine Exposure Assessment in Children (TEACH) study
The TEACH study was published in The Lancet Child & Adolescent Health in December 2021.
TEACH (TAF113577) was an open-label, non-comparative, multi-centre Phase 2b study to assess the pharmacokinetics (PK), safety, and efficacy of single-dose tafenoquine in the treatment of paediatric subjects with P. vivax malaria.
The primary objective was to evaluate the PK of tafenoquine in children and adolescents aged ≥2 years to <16 years with P. vivax in order to identify appropriate doses that achieve a similar exposure to that of the tafenoquine adult dose of 300 mg. Secondary objectives were to assess the safety of tafenoquine when administered to paediatric subjects with P. vivax malaria; to assess the clinical and parasitological efficacy of tafenoquine as a radical cure for paediatric subjects with P. vivax malaria when co-administered with chloroquine. Another secondary objective was to assess the PK of tafenoquine in infants aged ≥6 months to <2 years (weighing ≥5kg) with P. vivax (if data permitted).
In all, 60 paediatric subjects were recruited (median age 10 years [range 2 – 15 years]) and dosed at three sites in Vietnam and one in Colombia. There were no unexpected safety findings. The overall percentage of subjects reporting adverse events was similar to adult studies [37/60 (62%)], with the highest frequency adverse event being vomiting in 12 (20%) subjects. Five subjects vomited within the first hour after dosing and two spat out their doses. Two who had a repeat of vomiting following a second dose were excluded from the PK analyses.
All subjects were screened for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to receiving tafenoquine and excluded from the study if they had <70% G6PD enzyme activity levels.
For more information visit: https://clinicaltrials.gov/ct2/show/NCT02563496