Therapeutic Efficacy Study of AL and DP in Western Kenya
Status:
Completed
Trial end date:
2020-12-31
Target enrollment:
Participant gender:
Summary
Artemether-lumefantrine (AL) was adopted as first-line antimalarial therapy in Kenya in 2006,
and dihydroartemisinin-piperaquine (DP) as the second-line therapy in 2010. In order to
monitor the efficacy and potential development of resistance of Plasmodium falciparum
parasites to these two drugs, we will conduct an in-vivo study to monitor the efficacy of
these antimalarial therapies.
A standardized World Health Organization (WHO) in-vivo efficacy study will be conducted in
western Kenya among children 6-59 months of age with symptomatic, uncomplicated malaria
visiting the out-patient department of hospitals and/or clinics in western Kenya.
In this study, 350 children will be randomly assigned to be treated with either AL or DP.
Clinical, parasitologic, and hematologic parameters will be monitored over a 42-day follow-up
period. Molecular analysis will be conducted to determine the frequency of markers of
antimalarial resistance, and to differentiate recrudescence from reinfection. Results from
this antimalarial drug efficacy study will be used to assist the Kenya national malaria
control program (NMCP) in evaluating the national malaria treatment policy.
Phase:
N/A
Details
Lead Sponsor:
Kenya Medical Research Institute
Collaborator:
Centers for Disease Control and Prevention
Treatments:
Artemether Artemether, Lumefantrine Drug Combination Artenimol Lumefantrine Piperaquine