Effectiveness of a 6-dose regimen of Artemether-Lumefantrine for unsupervised treatment of uncomplicated childhood malaria in Calabar, Nigeria

Background: The six dose regimen of Artemether- Lumefantrine (AL), has high efficacy in clinical trials and is the first -line drug for treating uncomplicated malaria in Nigeria. The complex dosage schedule could militate against its effectiveness.Objective: To assess the effectiveness of AL prescribed under routineoutpatient conditions in the treatment of uncomplicated malaria.Methods: An open label, noncomparative trial to assess the effectivenessof AL in children 6 to 59 months with uncomplicated P. falciparum and parasite density between 1,000 and 250,000/ìL. Enrolled children received 6-dose course of AL (20/120mg tablets). The first dose was administered in the health facility and caregivers were instructed on how to administerthe remaining five doses at home.Results: Of the 1035 screened, 215 eligible children were enrolled and193 completed the study. Twenty two (22) patients withdrew from thestudy (18 were lost to follow-up, 3 violated protocol and 1 withdrewconsent). Adequate clinical and parasitological response (ACPR) was observed in 90.7%; late clinical failure in 7 (3.6%) and late parasitologicalfailure in 11 (5.7%).Conclusion: This study showed high efficacy of AL in treating uncomplicatedP. falciparum malaria in under-fives in Nigeria. Adherence by caregivers to the treatment regimen was quite good and so, should continue to be used in the home setting.Key words: Artemetherlumefantrine, effectiveness, adherence, uncomplicated malaria