Artemisinin-naphthoquine versus Artemether-lumefantrine for treating uncomplicated plasmodium falciparum malaria in children: A randomized controlled trial of efficacy and safety

Abstract

Introduction: Artemether-lumefantrine (AL), the most frequently prescribed ACTs for uncomplicated P. falciparum malaria, requires multiple doses which may militate against adherence. It is necessary to evaluate the efficacy and safety of single dose ACT like Artemisininnaphthoquine (ANQ) to enhance adherence.

Methods: This was an open label randomized controlled clinical trial. Eligible children were assigned to receive either a single dose of ANQ or six doses of AL following parental consent. A total of 108 children aged 5 – 14
years with uncomplicated falciparum malaria were enrolled and assigned as follows: 58 (ANQ) and 50 (AL). Participants were observed for 28 days and clinical and parasitological assessments carried out. Outcomes were  assessed based on World Health Organization protocol.

Results: A total of 97 patients completed the study. Overall 28-day cure  rate was 87.0% (47/54) and 81.4% (35/43) for ANQ and AL respectively. One patient (2.2%) in the AL group had Early Treatment Failure while seven (16.3%) had Late Parasitological Failure (LPF). LPF was also reported
in seven (13.0%) patients in the ANQ group. There was no Late Clinical Failure. A mild selflimiting papular rash was noted in one child in ANQ group. There was no serious adverse event.

Conclusions: The therapeutic efficacies of ANQ and AL were comparable.
A more robust, adequately powered, dose optimization study with  PCR-confirmed parasitological  outcome measures is needed.

Key words: Malaria, artemetherlume f a nt r ine , a r t emi s i nin -
naphthoquine, adherence, single and multiple dose therapy