A pilot randomized controlled trial to compare the effectiveness of two 14-day primaquine regimens for the radical cure of vivax malaria in South India

摘要: Radical cure of Plasmodium vivax malaria requires treatment with a blood schizonticide and hypnozoitocide (primaquine) to eradicate the dormant liver stages. There has been uncertainty about operational effectiveness optimum dosing currently recommended 14-day primaquine (PQ) course. A two centre, randomized, open-label, arm study was conducted in South India. Patients were randomized receive either high dose (0.5 mg base/kg body weight) or conventional (0.25 mg/kg) PQ for 14 days. Plasma concentrations carboxyprimaquine (CPQ) on 7th day measured by reverse phase performance liquid chromatography. Study subjects followed up 6 months. Recurrent infections genotyped using capillary fragment length polymorphism PCR-amplified microsatellite markers (MS07 MS 10). Fifty patients enrolled. Baseline characteristics laboratory features did not differ significantly between groups. Mean age population 42 ± 16.0 years. Recurrences 80–105 days later occurred 4 (8%) patients, each All recurrences had same genotype as that causing index infection suggesting all relapses. One relapse associated low CPQ poor adherence. This small pilot trial supports lower (0.25 mg/kg/day) 14 day regimen radical Trial registration Clinical Trials Registry-India, CTRI/2017/03/007999. Registered 3 March 2017, http://ctri.nic.in/Clinicaltrials/regtrial.php?modid=1&compid=19&EncHid=82755.86366 .