Efficacy and safety of a new pediatric artesunate-mefloquine drug formulation for the treatment of uncomplicated falciparum malaria in Gabon.

Marielle K Bouyou-Akotet; Michael Ramharter; Edgard Brice Ngoungou; Modeste Mabika Mamfoumbi; Mireille Pemba Mihindou; Michel A Missinou; Florian Kurth; Sabine Bélard; Selidji T Agnandji; Saadou Issifou; János L Heidecker; Sonja Trapp; Peter G Kremsner; Maryvonne Kombila

Efficacy and safety of a new pediatric artesunate-mefloquine drug formulation for the treatment of uncomplicated falciparum malaria in Gabon.

Marielle K Bouyou-Akotet ¹ Michael Ramharter Edgard Brice Ngoungou ^{1, 2} Modeste Mabika Mamfoumbi ¹ Mireille Pemba Mihindou ¹ Michel A Missinou Florian Kurth Sabine Bélard Selidji T Agnandji Saadou Issifou ³ János L Heidecker Sonja Trapp ⁴ Peter G Kremsner Maryvonne Kombila ^{1, *}

* Auteur correspondant

1 Département de Parasitologie, Mycologie et Médecine Tropicale

2 NETEC - Neuroépidémiologie Tropicale et Comparée

3 Hôpital Albert Schweitzer

4 IESE - Fraunhofer Institute for Experimental Software Engineering [Kaiserslautern]

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.

Type de document :

Article dans une revue

Domaine :

Sciences du Vivant [q-bio] / Santé publique et épidémiologie

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https://hal-unilim.archives-ouvertes.fr/hal-00934517
Contributeur : Elisabeth Grelier <>
Soumis le : mercredi 22 janvier 2014 - 11:04:50
Dernière modification le : lundi 7 octobre 2019 - 14:44:01

Efficacy and safety of a new pediatric artesunate-mefloquine drug formulation for the treatment of uncomplicated falciparum malaria in Gabon.

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Efficacy and safety of a new pediatric artesunate-mefloquine drug formulation for the treatment of uncomplicated falciparum malaria in Gabon.

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