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

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT00845533
Collaborator
Holley-Cotec Pharmaceuticals Co., LTD. (Other), Mahidol University (Other)
17.1
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Study Start Date :
Aug 1, 2007
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Jan 1, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 10 Years
    Sexes Eligible for Study:
    All
    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

      1. 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of California, San Francisco
    • Holley-Cotec Pharmaceuticals Co., LTD.
    • Mahidol University

    Investigators

    • Principal Investigator: Sunil Parikh, M.D., M.P.H., University of California, San Francisco
    • Principal Investigator: Philip J Rosenthal, M.D., University of California, San Francsico
    • Principal Investigator: Jean-Bosco Ouedraogo, M.D., PhD, Institut de Receherche en Sciences de la Sante Bobo-Dioulasso

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sunil Parikh, Assistant Professor, University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT00845533
    Other Study ID Numbers:
    • H40380-31179-01
    First Posted:
    Feb 18, 2009
    Last Update Posted:
    Jan 16, 2014
    Last Verified:
    Jan 1, 2014
    Additional relevant MeSH terms:
    Malaria
    Piperaquine
    Artenimol

    Study Results

    No Results Posted as of Jan 16, 2014