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

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ClinicalTrials.gov Identifier: NCT00845533
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : January 16, 2014
Holley-Cotec Pharmaceuticals Co., LTD.
Mahidol University
Information provided by (Responsible Party):
Sunil Parikh, University of California, San Francisco

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
Uncomplicated Malaria Drug: Dihydroartemisinin-Piperaquine Phase 4

Study Type : Interventional  (Clinical Trial)
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : August 2007
Primary Completion Date : December 2007
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 10 Years   (Child)
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
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845533

Sponsors and Collaborators
University of California, San Francisco
Holley-Cotec Pharmaceuticals Co., LTD.
Mahidol University
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

Responsible Party: Sunil Parikh, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00845533     History of Changes
Other Study ID Numbers: H40380-31179-01
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: January 16, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents