Evaluation of the efficacy and safety of artemether-lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in Nigerian infants and children

Catherine O Falade,Lateef A Salako,Hannah O Dada-Adegbola,Oluwatoyin O Ogunkunle,Philip Hunt,Ayoade M Oduola,Adegoke G Falade,Patricia Ibarra De Palacios,Mailis Virtanen

doi:10.1186/1475-2875-7-246

Abstract

BackgroundThe six-dose regimen of artemether-lumefantrine (AL) is now considered the gold standard for the treatment of uncomplicated Plasmodium falciparum malaria. There are few reports evaluating co-artemether in very young Nigerian infants and children. Results of the evaluation of the six-dose regimen in very young infants and children in Nigeria are presented in this report.MethodsAs part of a larger African study, this open label, non-comparative trial, assessed the efficacy and safety of six-dose regimen of AL tablets in 103 Nigerian infants and children weighing between five and 25 kg suffering from acute uncomplicated malaria. Treatment was administered under supervision over three days with children as in-patients. 12-lead ECG tracings were taken pre-treatment and at day 3.ResultsNinety-three infants and children completed the study as stipulated by the protocol. Mean fever and parasite clearance times for the intent to treat population (ITT) were 24.9 h ± (1.28) and 26 h ± (4.14) and the corresponding figures for the per-protocol population (PP) were 19.24 h ± 13.9 and 25.62 h ± 11.25 respectively. Day 14 cure rates for the ITT and PP were 95.1% and 100% respectively while day 28 cure rates were 91.3% and 95.7% respectively. The overall PCR corrected day 28 cure rate was 95.1% for the ITT. The six-dose regimen of AL was well tolerated with no drug-related serious adverse events. Although six patients recorded a QTc prolongation of > 60 ms on D3 over D0 recording, no patient recorded a QTc interval > 500 ms.ConclusionThe six-dose regimen of AL tablets is safe and effective for the treatment of acute uncomplicated malaria in Nigerian infants and children weighing between five and 25 kg.Trial registrationNCT00709969

Highlights

The six-dose regimen of artemether-lumefantrine (AL) is considered the gold standard for the treatment of uncomplicated Plasmodium falciparum malaria
One patient in BWG2 died on the ninth day of study from severe gastroenteritis, which was not considered drug-related
The six-dose regimen of AL was found to be well tolerated, safe and highly efficacious in the treatment of acute uncomplicated P. falciparum malaria in Nigerian children and infants weighing as little as 5 kg

Summary

Introduction

The six-dose regimen of artemether-lumefantrine (AL) is considered the gold standard for the treatment of uncomplicated Plasmodium falciparum malaria. There are few reports evaluating co-artemether in very young Nigerian infants and children. Results of the evaluation of the six-dose regimen in very young infants and children in Nigeria are presented in this report. The deleterious consequences of malaria continue to increase in endemic areas as a result of the emergence and widespread dissemination of drug resistant Plasmodium falciparum [1,2]. Artemether-lumefantrine (AL) is a fixeddose combination tablet containing 20 mg of artemether and 120 mg of lumefantrine This combination combines the benefits of a rapid schizonticidal effect of artemether with a slow but longer acting schizonticidal effect of lumefantrine. The six-dose regimen is the global standard regimen for AL [8]

Methods

Results

Discussion

Conclusion