PMID- 20519597
OWN - NLM
STAT- MEDLINE
DCOM- 20100623
LR  - 20211020
IS  - 1476-1645 (Electronic)
IS  - 0002-9637 (Print)
IS  - 0002-9637 (Linking)
VI  - 82
IP  - 6
DP  - 2010 Jun
TI  - Tolerability and efficacy of a pediatric granule formulation of 
      artesunate-mefloquine in young children from Cameroon with uncomplicated 
      falciparum malaria.
PG  - 1034-40
LID - 10.4269/ajtmh.2010.09-0704 [doi]
AB  - 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.
FAU - Tietche, Felix
AU  - Tietche F
AD  - Faculty of Medicine and Biomedical Sciences, University of Yaounde 1, Yaounde, 
      Cameroon, Switzerland.
FAU - Chelo, David
AU  - Chelo D
FAU - Mina Ntoto, Njiki Kinkela
AU  - Mina Ntoto NK
FAU - Djoukoue, Florence Minjiwa
AU  - Djoukoue FM
FAU - Hatz, Christoph
AU  - Hatz C
FAU - Frey, Sarabel
AU  - Frey S
FAU - Frentzel, Adrian
AU  - Frentzel A
FAU - Trapp, Sonja
AU  - Trapp S
FAU - Zielonka, Roland
AU  - Zielonka R
FAU - Mueller, Edgar A
AU  - Mueller EA
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am J Trop Med Hyg
JT  - The American journal of tropical medicine and hygiene
JID - 0370507
RN  - 0 (Antimalarials)
RN  - 0 (Artemisinins)
RN  - 0 (Dosage Forms)
RN  - 0 (Drug Combinations)
RN  - 60W3249T9M (Artesunate)
RN  - TML814419R (Mefloquine)
SB  - IM
MH  - Antimalarials/administration & dosage/therapeutic use
MH  - Artemisinins/*administration & dosage/*therapeutic use
MH  - Artesunate
MH  - Cameroon/epidemiology
MH  - Child
MH  - Child, Preschool
MH  - Dosage Forms
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Infant
MH  - Malaria, Falciparum/*drug therapy/epidemiology
MH  - Male
MH  - Mefloquine/*administration & dosage/*therapeutic use
PMC - PMC2877408
COIS- Disclosure: Adrian Frentzel and Sonja Trapp are employees of Mepha Ltd. This 
      statement is made in the interest of full disclosure and not because the authors 
      consider this a conflict of interest.
EDAT- 2010/06/04 06:00
MHDA- 2010/06/24 06:00
PMCR- 2010/06/01
CRDT- 2010/06/04 06:00
PHST- 2010/06/04 06:00 [entrez]
PHST- 2010/06/04 06:00 [pubmed]
PHST- 2010/06/24 06:00 [medline]
PHST- 2010/06/01 00:00 [pmc-release]
AID - 82/6/1034 [pii]
AID - 10.4269/ajtmh.2010.09-0704 [doi]
PST - ppublish
SO  - Am J Trop Med Hyg. 2010 Jun;82(6):1034-40. doi: 10.4269/ajtmh.2010.09-0704.