Short-course, high-dose primaquine regimens for treatment of liver-stage vivax malaria in children
- Author(s)
- Moore, BR; Salman, S; Tobe, R; Benjamin, J; Yadi, G; Kasian, B; Laman, M; Robinson, LJ; Page-Sharp, M; Betuela, I; Batty, KT; Manning, L; Mueller, I; Davis, TME;
- Journal Title
- International Journal of Infectious Diseases
- Abstract
- OBJECTIVES: To assess the pharmacokinetics, safety, and tolerability of two high-dose short-course PQ regimens compared to standard care in children with Plasmodium vivax infections. METHODS: We performed an open-label paediatric dose-escalation study in Madang, Papua New Guinea (Clinicaltrials.gov NCT02364583). Children aged 5-10 years with confirmed blood-stage vivax malaria and normal G6PD activity were allocated to one of three PQ treatment regimens in a stepwise design (Group A: 0·5 mg/kg once daily for 14-days, Group B: 1 mg/kg once daily for 7-days, and Group C: 1 mg/kg twice daily for 3·5-days). Study assessments were completed at each treatment time-point, and fortnightly for 2-months after PQ administration. RESULTS: Between August 2013 and May 2018, 707 children were screened and 73 met eligibility criteria (15, 40 and 16 allocated to Groups A, B and C, respectively). All children completed study procedures. The three regimens were safe and generally well tolerated. Pharmacokinetic analysis indicated that additional weight adjustment of conventionally recommended mg/kg PQ doses is not necessary to ensure therapeutic plasma concentrations in paediatric patients. CONCLUSIONS: A novel ultra-short 3·5-day PQ regimen has potential benefits for improving treatment outcomes in children with vivax malaria that warrants further investigation in large-scale clinical trial.
- Publisher
- Elsevier
- Keywords
- Primaquine; children; pharmacokinetics; safety; short-course regimen; vivax malaria
- PubMed ID
- 37269941
- Publisher's Version
- https://doi.org/10.1016/j.ijid.2023.05.063
- Open Access at Publisher's Site
https://doi.org/10.1016/j.ijid.2023.05.063- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2023-06-26 09:53:31
Last Modified: 2023-07-12 08:45:20