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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00845533
Other study ID # H40380-31179-01
Secondary ID
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
Accepts healthy volunteers
Gender Both
Age group 6 Months to 10 Years
Eligibility Inclusion Criteria:

1. Positive screening thick blood smear

2. Fever (> 37.5ÂșC 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


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
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