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

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

Conditions: Uncomplicated Malaria

Treatments: Drug: Dihydroartemisinin-Piperaquine

Study type: Interventional

Funder types: Other

Identifiers

NCT00845533

H40380-31179-01

Details and patient eligibility

About

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.

Sex: All

Ages: 6 months to 10 years old

Volunteers: No Healthy Volunteers

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