Status:
COMPLETED
Pharmacokinetics of Dihydroartemisinin-Piperaquine in the Treatment of Uncomplicated Malaria in Children in Burkina Faso
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Holley-Cotec Pharmaceuticals Co., LTD.
Mahidol University
Conditions:
Uncomplicated Malaria
Eligibility:
All Genders
6-10 years
Phase:
PHASE4
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-pipe...
Eligibility Criteria
Inclusion
- Positive screening thick blood smear
- Fever (\> 37.5ºC axillary) or history of fever in the previous 24 hours
- Age ≥ 6 months to 10 years
- Weight \> 5 kg
- Absence of any history of serious side effects to study medications
- No evidence of a concomitant febrile illness in addition to malaria
- No history of antimalarial use in the previous two weeks
- P. falciparum mono-infection
- Parasite density 2000-200,000/ul
- Provision of informed consent and ability to participate in 42-day follow-up
Exclusion
- Danger signs or evidence of severe malaria
- Hemoglobin levels \< 5.0 gm/dL
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
End Date :
January 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00845533
Start Date
August 1 2007
End Date
January 1 2009
Last Update
January 16 2014
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