[A randomized clinical trial comparing the effectiveness and tolerability of artemisinine-naphthoquine (Arco®) and artemether-lumefantrine (Coartem®) in the treatment of uncomplicated malaria in Benin]. / Essai clinique randomisé comparant l'efficacité et la tolérance de la combinaison artémisinine-naphthoquine (Arco®) et artéméther-luméfantrine (Coartem®) dans le traitement du paludisme simple au Bénin.

ABSTRACT

The Ministry of Health recommended in Benin, since 2004, artemisinin-based combination, artemether-lumtefantrine (Coartem®), therapy for the treatment of uncomplicated malaria. To resolve the difficulties related to observance, we are interested in a new combination, artemisinin-naphthoquine (Arco®). A study was conducted to assess and compare the efficacy and tolerability of the fixed combination artemisinin (125 mg)-naphthoquine (50 mg), a single-dose drug, administered one day versus artemether (20 mg)-lumefantrine (120 mg).The clinical assessment was a single-blinded, two-arm, randomized trial comparing Arco® combination as a single-dose regimen and three-day regimen of Coartem® for the treatment of uncomplicated falciparum malaria, from july to october 2008 and may to september 2009, with 28 days of follow-up in children. PCR genotyping was used to classify re-infection or recrudescence. The primary outcome measures for efficacy were cure rates on days 3, 7, 14, 21 and 28. Secondary outcomes included parasite clearance time and fever clearance time. The main outcome measures for safety were incidences of post-treatment clinical and laboratory adverse events. A total of 174 patients (84 in Arco® group and 90 in Coartem® group) were evaluated for clinical and parasitological outcomes. The cure rate was 98.8% for Arco® and 100% for Coartem® on day 28, with no statistically significant difference. Fever clearance was obtained within 24 hours in both groups. The parasite clearance is obtained at 48 hours in Arco® group and at 60 hours in Coartem® group. Both treatments were well tolerated without major side effects. This study therefore concluded that the combination of artemisinin-naphthoquine is as effective and well tolerated as the combination artemether-lumefantrine in the treatment of uncomplicated malaria in Benin children. This medication administered in single dose is therapy of choice to reduce compliance problems during malaria treatment and also to facilitate community-based care of malaria.