title: Efficacy and safety of a new pediatric artesunate-mefloquine drug formulation for the treatment of uncomplicated falciparum malaria in Gabon.
abstract: Pediatric drug formulations of artemisinin combination therapies are urgently needed for improving the treatment of children suffering from uncomplicated malaria. The aim of this clinical trial was to evaluate the efficacy, safety and tolerability of a novel pediatric fixed-dose granule formulation of artesunate-mefloquine and a new co-blister tablet formulation. A total of 71 children aged 1-13 years suffering from uncomplicated falciparum malaria were stratified into two groups according to weight: 10-20 kg, pediatric group (n = 41); 20-40 kg, tablet group (n = 30). All the children were treated once daily for three days: the pediatric group received the novel granule formulation, the tablet group received the co-blister tablets. The PCR-corrected cure rate on day 28 was evaluated. There was no reappearance of parasitemia during the follow-up period and the day-28 cure rate was therefore 100% in per-protocol analysis. In intention-to-treat analysis the cure rates were 95% in the pediatric group and 97% in the tablet group. The most frequent adverse events were vomiting (17%), abdominal pain (11%) and headache (17%). This study confirms the excellent efficacy and favorable safety and tolerability profile of a novel pediatric artesunate-mefloquine formulation for treatment in African children.
authors.affiliation: Faculty of Medicine, Department of Parasitology, Mycology, and Tropical Medicine, Université des Sciences de la Santé, Libreville, Gabon.
authors.forename: Marielle K
authors.initials: MK
authors.lastname: Bouyou-Akotet
authors.forename: Michael
authors.initials: M
authors.lastname: Ramharter
authors.forename: Edgard Brice
authors.initials: EB
authors.lastname: Ngoungou
authors.forename: Modeste Mabika
authors.initials: MM
authors.lastname: Mamfoumbi
authors.forename: Mireille Pemba
authors.initials: MP
authors.lastname: Mihindou
authors.forename: Michel A
authors.initials: MA
authors.lastname: Missinou
authors.forename: Florian
authors.initials: F
authors.lastname: Kurth
authors.forename: Sabine
authors.initials: S
authors.lastname: Bélard
authors.forename: Selidji T
authors.initials: ST
authors.lastname: Agnandji
authors.forename: Saadou
authors.initials: S
authors.lastname: Issifou
authors.forename: János L
authors.initials: JL
authors.lastname: Heidecker
authors.forename: Sonja
authors.initials: S
authors.lastname: Trapp
authors.forename: Peter G
authors.initials: PG
authors.lastname: Kremsner
authors.forename: Maryvonne
authors.initials: M
authors.lastname: Kombila
mesh_terms: D000284:Administration, Oral; D000962:Antimalarials / Q000627:therapeutic use*; D037621:Artemisinins / Q000008:administration & dosage* / Q000009:adverse effects; D000077332:Artesunate; D002648:Child; D002675:Child, Preschool; D003906:Developing Countries; D004338:Drug Combinations; D005260:Female; D005681:Gabon; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy*; D008297:Male; D015767:Mefloquine / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000962:Antimalarials; D037621:Artemisinins; D004338:Drug Combinations; D000077332:Artesunate; D015767:Mefloquine