Short-course, high-dose primaquine regimens for the treatment of liver-stage vivax malaria in children

Brioni R. Moore, Sam Salman, Roselyn Tobe, John Benjamin, Gumul Yadi, Bernadine Kasian, Moses Laman, Leanne J. Robinson, Madhu Page-Sharp, Inoni Betuela, Kevin T. Batty, Laurens Manning, Ivo Mueller, Timothy M.E. Davis

Research output: Contribution to journalArticlepeer-review


Objectives: To assess the pharmacokinetics, safety, and tolerability of two high-dose, short-course primaquine (PQ) regimens compared with standard care in children with Plasmodium vivax infections. Methods: We performed an open-label pediatric dose-escalation study in Madang, Papua New Guinea ( NCT02364583). Children aged 5-10 years with confirmed blood-stage vivax malaria and normal glucose-6-phosphate dehydrogenase 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). The 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 the eligibility criteria (15, 40, and 16 allocated to groups A, B, and C, respectively). All children completed the study procedures. The three regimens were safe and generally well tolerated. The pharmacokinetic analysis indicated that an additional weight adjustment of the conventionally recommended milligram per kilogram PQ doses is not necessary to ensure the therapeutic plasma concentrations in pediatric patients. Conclusions: A novel, ultra-short 3.5-day PQ regimen has potential benefits for improving the treatment outcomes in children with vivax malaria that warrants further investigation in a large-scale clinical trial.

Original languageEnglish
Pages (from-to)114-122
Number of pages9
JournalInternational Journal of Infectious Diseases
Publication statusPublished - Sept 2023


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