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.
Tietche
Félix
F
Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaoundé, Cameroon, Switzerland.
Chelo
David
D
Mina Ntoto
Njiki Kinkela
NK
Djoukoue
Florence Minjiwa
FM
Hatz
Christoph
C
Frey
Sarabel
S
Frentzel
Adrian
A
Trapp
Sonja
S
Zielonka
Roland
R
Mueller
Edgar A
EA
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