Treatment of Uncomplicated Childhood Malaria in Tanzania by Artemether+Lumefantrine - Efficacy and Genotyping
Status:
Completed
Trial end date:
2006-07-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Karolinska University Hospital
Collaborator:
Muhimbili University of Health and Allied Sciences
Treatments:
Artemether Artemether-lumefantrine combination Artemether, Lumefantrine Drug Combination Artemisinins Lumefantrine