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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Holley-Cotec Pharmaceuticals Co., LTD.; Mahidol University
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin; Piperaquine

Criteria

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