NCT00845533

Pharmacokinetics of Dihydroartemisinin-Piperaquine in the Treatment of Uncomplicated Malaria in Children in Burkina Faso

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: —
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 6 Months – 10 Years
• Healthy volunteers: —

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.

Conditions

• Uncomplicated Malaria

Interventions

Type	Name	Description
DRUG	Dihydroartemisinin-Piperaquine

Timeline

• Start date: 2007-08-01
• Primary completion: 2007-12-01
• Completion: 2009-01-01
• First posted: 2009-02-18
• Last updated: 2014-01-16