Pharmacokinetics of Dihydroartemisinin-Piperaquine in the Treatment of Uncomplicated Malaria in Children in Burkina Faso
- Conditions
- Uncomplicated Malaria
- Registration Number
- NCT00845533
- Lead Sponsor
- University of California, San Francisco
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
- 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
- Danger signs or evidence of severe malaria
- Hemoglobin levels < 5.0 gm/dL
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method