Artemisinin-Naphthoquine Combination Therapy for Uncomplicated Pediatric Malaria: a Tolerability, Safety, and Preliminary Efficacy Study

Author:

Benjamin John,Moore Brioni,Lee Sook Ting,Senn Michèle,Griffin Susan,Lautu Dulci,Salman Sam,Siba Peter,Mueller Ivo,Davis Timothy M. E.

Abstract

ABSTRACTArtemisinin-naphthoquine (ART-NQ) is a fixed-dose coformulated antimalarial therapy recommended as a single-dose treatment and marketed in Papua New Guinea among other tropical countries. We conducted a tolerability, safety, and efficacy study of ART-NQ for Papua New Guinean children aged 5 to 12 years with uncomplicated malaria, comparing single-dose ART-NQ (15 and 6 mg/kg of body weight) given with water (group 1;n= 15), single-dose ART-NQ (22 and 9 mg/kg) given with milk (group 2;n= 17), or two daily doses of 22 and 9 mg/kg given with water (group 3;n= 16). Of the 48 children (45 withPlasmodium falciparummalaria, 2 withPlasmodium vivaxmalaria, and 1 with mixed-species malaria), 2 in group 2 did not attend all follow-up assessments. All regimens were well tolerated, with no serious adverse events. There were no clinically significant changes in pulse, blood pressure, rate-corrected electrocardiographic QT, routine biochemistry/hematology, or hearing after treatment. Fever clearance was prompt. Mean 50% parasite clearance times were 4, 4, and 5 h for groups 1, 2, and 3, respectively. One group 1 patient had PCR-confirmedP. falciparumrecrudescence at day 23; four had PCR-confirmedP. falciparumreinfections on day 28 or 42; and three hadP. vivaxinfections detected on day 42. The only recurrent parasitemia in groups 2 and 3 occurred in a group 2 child who developed aP. vivaxinfection on day 42. Day 14 gametocyte positivity levels were 20%, 27%, and 9% in groups 1, 2, and 3, respectively. The lower single ART-NQ dose was associated with relatively frequent recurrence of parasitemia, but the prolonged gametocytemia in all three groups has implications for the transmission of malaria.

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

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