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

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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Key information

Conditions

Uncomplicated Malaria

Age range

6 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Danger signs or evidence of severe malaria
Hemoglobin levels < 5.0 gm/dL

Treatment and study plan

Dihydroartemisinin-Piperaquine

Drug

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

Holley-Cotec Pharmaceuticals Co., LTD.
Mahidol University

Registry information

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2009
First posted: Feb 18, 2009
Registry last updated: Jan 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed