Primaquine radical cure in patients with Plasmodium falciparum malaria in areas co-endemic for P falciparum and Plasmodium vivax (PRIMA): a multicentre, open-label, superiority randomised controlled trial.

"Declaration of interests KT is funded by a CSL Century fellowship. JAS and RNP are funded by National Health and Medical Research Council Leadership Investigator Grants (1196068 and 2008501). All other authors declare no competing interests."

"AcknowledgmentsWe thank all patients who participated in this study and the staff members involved in the trial at the recruiting and coordinating centres. The members of the data and safety monitoring board were Harin Karunajeewa (Chair), Matthew Grigg, and Sophie Zaloumis (statistician), later replaced by Sue Jean Lee. Funding for this study was obtained from the Australian Academy of Science Regional Collaborations Program, Bill & Melinda Gates Foundation (OPP1164105/INV-010504), and National Health and Medical Research Council (GNT1132975). KT is funded by a CSL Century fellowship. JAS and RNP are funded by National Health and Medical Research Council Leadership Investigator Grants (1196068 and 2008501). All other authors declare no competing interests."

"Methods: We did a multicentre, open-label, superiority randomised controlled trial in five health clinics in Bangladesh, Indonesia, and Ethiopia. In Bangladesh and Indonesia, patients were excluded if they were younger than 1 year, whereas in Ethiopia patients were excluded if they were younger than 18 years. Patients with uncomplicated P falciparum monoinfection who had fever or a history of fever in the 48 h preceding clinic visit were eligible for enrolment and were required to have a glucose-6-dehydrogenase (G6PD) activity of 70% or greater. Patients received blood schizontocidal treatment (artemether–lumefantrine in Ethiopia and Bangladesh and dihydroartemisinin–piperaquine in Indonesia) and were randomly assigned (1:1) to receive either high-dose short-course oral primaquine (intervention arm; total dose 7 mg/kg over 7 days) or standard care (standard care arm; single dose oral primaquine of 0·25 mg/kg). Random assignment was done by an independent statistician in blocks of eight by use of sealed envelopes. All randomly assigned and eligible patients were included in the primary and safety analyses. The per-protocol analysis excluded those who did not complete treatment or had substantial protocol violations. The primary endpoint was the incidence risk of P vivax parasitaemia on day 63. This trial is registered at ClinicalTrials.gov, NCT03916003."