A Phase 4 interventional study of Dihydroartemisinin-Piperaquine in Uncomplicated Malaria, sponsored by University of California, San Francisco. Completed. Open to participants aged 6 Months to 10 Years. Per ClinicalTrials.gov, last updated 2014-01-16.
Sponsored by University of California, San Francisco · Phase 4 and Interventional
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.
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University of California, San Francisco