Pharmacokinetics of Dihydroartemisinin-Piperaquine in the Treatment of Uncomplicated Malaria in Children in Burkina Faso
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ClinicalTrials.gov Identifier: NCT00845533
: February 18, 2009
Last Update Posted
: January 16, 2014
University of California, San Francisco
Holley-Cotec Pharmaceuticals Co., LTD.
Information provided by (Responsible Party):
Sunil Parikh, University of California, San Francisco
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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Ages Eligible for Study:
6 Months to 10 Years (Child)
Sexes Eligible for Study:
Positive screening thick blood smear
Fever (> 37.5ºC axillary) or history of fever in the previous 24 hours
Age ≥ 6 months to 10 years
Weight > 5 kg
Absence of any history of serious side effects to study medications
No evidence of a concomitant febrile illness in addition to malaria
No history of antimalarial use in the previous two weeks
P. falciparum mono-infection
Parasite density 2000-200,000/ul
Provision of informed consent and ability to participate in 42-day follow-up