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

University of California, San Francisco

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Conditions

Uncomplicated Malaria

Interventions

Dihydroartemisinin-PiperaquineDRUG

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 10 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Positive screening thick blood smear 2. Fever (\> 37.5ºC axillary) or history of fever in the previous 24 hours 3. Age ≥ 6 months to 10 years 4. Weight \> 5 kg 5. Absence of any history of serious side effects to study medications 6. No evidence of a concomitant febrile illness in addition to malaria 7. No history of antimalarial use in the previous two weeks 8. P. falciparum mono-infection 9. Parasite density 2000-200,000/ul 10. Provision of informed consent and ability to participate in 42-day follow-up Exclusion Criteria: 1. Danger signs or evidence of severe malaria 2. Hemoglobin levels \< 5.0 gm/dL

Data from ClinicalTrials.gov

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