This study will assess the safety and efficacy of artemether-lumefantrine tablets (6-dose regimen) in African infants / children with acute uncomplicated falciparum malaria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
310
20mg artemether and 120 mg lumefantrine, tablet, dose based on body weight, 3 days treatment 5 - \< 10kg (BWG 1) = 6 doses of 1 tablet / 10 - \< 15kg (BWG 2) = 6 doses of 1 tablet / 15 - ≤ 25kg (BWG 3) = 6 doses of 2 tablets
Kemri-Wellcome Trust Programme
Kilifi, Kenya
University College Hospital Malaria Research Laboratories Institute for Advance Medical Research and Training
Ibadan, Nigeria
Muhimbili University College of Health Sciences Department of Parasitology and Medical Entomology, Box 65011
Dar es Salaam, Tanzania
Adverse events, SAEs; hematology and biochemistry parameters; electrocardiogram; urine values; vital signs; physical neurological examinations; and neurological examinations
Time frame: 28 days
Proportion of patients free of parasites at 7, 14 and at 28 days
Time to clearance from parasites (asexual forms)
Time to clearance of fever
Time to clearance of gametocytes (parasite sexual forms)
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