Seven-day versus fourteen-day low-dose primaquine for Plasmodium vivax malaria in India: an open-label, non-inferiority, randomised, controlled trial

Abstract

Background India has a high burden of Plasmodium vivax malaria. Current malaria treatment guidelines recommend a total primaquine dose of 3·5 mg/kg administered over 14 days to prevent relapse in P. vivax infection, however, adherence is generally poor, impacting effectiveness. We aimed to determine the efficacy and safety of the same total dose of 3·5 mg/kg administered over 7 days in India. Methods We conducted an open label, non-inferiority, randomised controlled trial at two sites in India. Febrile patients older than 16 years with microscopically confirmed P. vivax mono-infection and normal (≥30%) G6PD activity were eligible for enrolment. Patients were randomly assigned (1:1) using blo..