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

Uncomplicated Malaria Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845533
• Other study ID #: H40380-31179-01
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2009
• Last updated: January 15, 2014
• Start date: August 2007
• Est. completion date: January 2009

Study information

• Verified date: January 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardBurkina Faso: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2009
• Est. primary completion date: December 2007
• Gender: Both
• Age group: 6 Months to 10 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Malaria
• Uncomplicated Malaria

Intervention

Drug:
• Dihydroartemisinin-Piperaquine

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Holley-Cotec Pharmaceuticals Co., LTD., Mahidol University