1. Efficacy and safety of a new pediatric artesunate-mefloquine drug formulation for the treatment of uncomplicated falciparum malaria in Gabon
- Author
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Maryvonne Kombila, Sabine Bélard, Marielle K. Bouyou-Akotet, Modeste Mabika Mamfoumbi, Mireille Pemba Mihindou, Saadou Issifou, Selidji T Agnandji, János L. Heidecker, Michael Ramharter, Edgard Brice Ngoungou, Peter G. Kremsner, Florian Kurth, Michel A. Missinou, Sonja Trapp, Département de Parasitologie, Mycologie et Médecine Tropicale, Faculté de Médecine-Université de Libreville, Neuroépidémiologie Tropicale et Comparée (NETEC), Université de Limoges (UNILIM)-Institut d'Epidémiologie Neurologique et de Neurologie Tropicale-Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST FR CNRS 3503), Hôpital Albert Schweitzer, Fraunhofer Institute for Experimental Software Engineering (Fraunhofer IESE), and Fraunhofer (Fraunhofer-Gesellschaft)
- Subjects
Male ,Administration, Oral ,Artesunate ,Parasitemia ,chemistry.chemical_compound ,0302 clinical medicine ,MESH: Child ,030212 general & internal medicine ,Artemisinin ,Malaria, Falciparum ,Child ,MESH: Developing Countries ,Mefloquine ,MESH: Malaria, Falciparum ,General Medicine ,Artemisinins ,3. Good health ,Drug Combinations ,Tolerability ,Anesthesia ,Child, Preschool ,MESH: Administration, Oral ,Female ,MESH: Mefloquine ,medicine.drug ,medicine.medical_specialty ,MESH: Gabon ,030231 tropical medicine ,03 medical and health sciences ,Antimalarials ,Internal medicine ,MESH: Artemisinins ,medicine ,Humans ,Gabon ,Adverse effect ,Developing Countries ,MESH: Drug Combinations ,MESH: Humans ,business.industry ,MESH: Child, Preschool ,medicine.disease ,MESH: Antimalarials ,MESH: Male ,Clinical trial ,chemistry ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,business ,MESH: Female ,Malaria - Abstract
International audience; 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.
- Published
- 2009