Tolerability and efficacy of a pediatric granule formulation of artesunate-mefloquine in young children from Cameroon with uncomplicated falciparum malaria.
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.
Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaoundé, Cameroon, Switzerland.
Félix
F
Tietche
David
D
Chelo
Njiki Kinkela
NK
Mina Ntoto
Florence Minjiwa
FM
Djoukoue
Christoph
C
Hatz
Sarabel
S
Frey
Adrian
A
Frentzel
Sonja
S
Trapp
Roland
R
Zielonka
Edgar A
EA
Mueller
D000962:Antimalarials / Q000008:administration & dosage / Q000627:therapeutic use; D037621:Artemisinins / Q000008:administration & dosage* / Q000627:therapeutic use*; D000077332:Artesunate; D002163:Cameroon / Q000453:epidemiology; D002648:Child; D002675:Child, Preschool; D004304:Dosage Forms; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007223:Infant; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000453:epidemiology; D008297:Male; D015767:Mefloquine / Q000008:administration & dosage* / Q000627:therapeutic use*
D000962:Antimalarials; D037621:Artemisinins; D004304:Dosage Forms; D004338:Drug Combinations; D000077332:Artesunate; D015767:Mefloquine