Pharmacokinetics of Dihydroartemisinin-Piperaquine in the Treatment of Uncomplicated Malaria in Children in Burkina Faso
Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
Summary
This will be an open-label trial in Burkina Faso assessing the pharmacokinetics of the
antimalarial combination of dihydroartemisinin/piperaquine (DP, Duocotexcin) in children.
Dihydroartemisinin-piperaquine is a promising candidate for first-line therapy of malaria. We
hypothesize that the disposition and pharmacokinetics of DP will be altered in children, and
this will alter the efficacy and/or toxicity of DP. We will test this hypothesis in this
open-label trial in Burkina Faso. The target population includes residents, aged 6 months to
10 years in Bobo-Dioulasso. Children who present to the study clinics with symptoms
suggestive of malaria will be screened with a thick blood smear. Subjects who meet selection
criteria of treatment efficacy will be treated and followed up for 42 days. Pharmacokinetic
sampling for DP will occur on selected follow-up days.
Phase:
Phase 4
Details
Lead Sponsor:
University of California, San Francisco
Collaborators:
Holley-Cotec Pharmaceuticals Co., LTD. Mahidol University