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.

Pädiatrische Medikamentenformulierungen sind ein wichtiger Fortschritt in der Therapie von afrikanischen Kindern, die an Malaria tropica erkrankt sind. In dieser klinischen Studie wurde die Wirksamkeit, Sicherheit und Verträglichkeit einer neuen pädiatrischen Artesunat-Mefloquin Koformulierung im Vergleich mit einer Tablettenformulierung evaluiert. Einundsiebzig pädiatrische Patienten am Albert Schweitzer Spital in Lambaréné, Gabun, die an unkomplizierter Malaria tropica litten, wurden nach Körpergewicht stratifiziert, um mit der pädiatrischen (10 – 20 kg; n = 41) oder der Tabletten-Formulierung (20 – 40 kg; n = 30) therapiert zu werden. Die PCR korrigierte Heilungsrate war 100 % am Tag 28. Die häufigsten Nebenwirkungen waren Erbrechen (17 %), abdominelle Schmerzen (11 %) und Cephalea (17 %). Diese Studie bestätigt die hervorragende Wirksamkeit und gute Verträglichkeit von Artesunat-Mefloquin zur Therapie pädiatrischer Patienten in Afrika.