Tolerability and Efficacy of a Pediatric Granule Formulation of Artesunate-Mefloquine in Young Children from Cameroon with Uncomplicated Falciparum Malaria

• Published in: The American journal of tropical medicine and hygiene Vol. 82; no. 6; pp. 1034 - 1040
• Main Authors: Tietche, Félix, Chelo, David, Mina Ntoto, Njiki Kinkela, Djoukoue, Florence Minjiwa, Hatz, Christoph, Frey, Sarabel, Frentzel, Adrian, Trapp, Sonja, Zielonka, Roland, Mueller, Edgar A.
• Format: Journal Article
• Language: English
• Published: Deerfield, IL American Society of Tropical Medecine and Hygiene 01.06.2010; The American Society of Tropical Medicine and Hygiene
• Subjects: Antibiotics. Antiinfectious agents. Antiparasitic agents; Antimalarials - administration & dosage; Antimalarials - therapeutic use; Antiparasitic agents; Artemisinins - administration & dosage; Artemisinins - therapeutic use; Biological and medical sciences; Cameroon - epidemiology; Child; Child, Preschool; Dosage Forms; Drug Combinations; Female; Human protozoal diseases; Humans; Infant; Infectious diseases; Malaria; Malaria, Falciparum - drug therapy; Malaria, Falciparum - epidemiology; Male; Medical sciences; Mefloquine - administration & dosage; Mefloquine - therapeutic use; Parasitic diseases; Pharmacology. Drug treatments; Protozoal diseases; Cameroon; Africa; Human; Protozoa; Antimalarial; Pediatrics; Apicomplexa; Protozoal disease; Mefloquine; Malaria; Parasitosis; Infection; Plasmodium falciparum; Artesunate; Dosage form; Parasiticide; Tropical medicine; Child
• ISSN: 0002-9637; 1476-1645; 1476-1645
• DOI: 10.4269/ajtmh.2010.09-0704

A fixed-dose pediatric formulation of artesunate and mefloquine (Artequin Pediatric) has been developed. In this open, non-comparative study in Cameroonian children with uncomplicated falciparum malaria, the safety and efficacy of this formulation was tested, with a particular emphasis on the risk of neuropsychiatric adverse events (AEs). In total, 220 subjects, weighing between 10 and 20 kg, were enrolled; 213 qualified for analysis. Artesunate-mefloquine was given once daily for 3 days. Overall, 13.1% of patients reported mild to moderate neuropsychiatric AEs (elicited through a structured questionnaire or reported spontaneously) out of which 3.8% (mainly insomnia) were considered drug-related. Other drug-related AEs were infrequent (< 3%). Polymerase chain reaction-corrected cure rate (adequate clinical and parasitological response) determined by survival analysis at 28 and 63 days was 96.6%. New infections were observed in 11.2% of evaluable patients at 63 days. The new formulation was well tolerated and efficacious in the population investigated.