The purpose of this explorative clinical trial is to study parasite population dynamics, diversity and clearance kinetics of Plasmodium falciparum as well as determination of the molecular mechanisms associated with drug resistance during the early phase of artemether-lumefantrine treatment when the drug intake is either accompanied with or without intake of fatty food. The hypothesis is that intake of fatty food together with artemether-lumefantrine will enhance parasite clearance and thereby decrease the risk of early selection of genetic markers related to drug resistance. The study population is children aged 1-10 years with uncomplicated malaria in Bagamoyo District, Tanzania. Enrolled children will be randomly allocated to either intake of a fatty meal or not together with the study drug. Artemether-lumefantrine will be given twice daily for 3 days in standard doses according to bodyweight. Study participants will be admitted during the study period (3 days)to allow close supervision and detailed blood sampling.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
All treatment doses given either accompanied or not-accompanied with intake of fatty food.
Fukayosi Primary Health Care Center
Fukayosi, Bagamoyo District, Tanzania
Number of P.falciparum genotypes identified at baseline compared with accumulated number of genotypes in all blood samples
Time frame: 72 hours
Clearance kinetics of P. falciparum measured with PCR genotyping compared with blood slide reading
Time frame: 72 hours
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