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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Uncomplicated Malaria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Dihydroartemisinin-Piperaquine

Intervention Type DRUG

Eligibility Criteria

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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