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

This study has been completed.
Sponsor:
Collaborators:
Holley-Cotec Pharmaceuticals Co., LTD.
Mahidol University
Information provided by (Responsible Party):
Sunil Parikh, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00845533
First received: February 17, 2009
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Uncomplicated Malaria
Drug: Dihydroartemisinin-Piperaquine
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Study Start Date: August 2007
Study Completion Date: January 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Months to 10 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845533

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
  More Information

No publications provided

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
Study First Received: February 17, 2009
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board
Burkina Faso: Ministry of Health

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Dihydroquinghaosu
Artemisinins
Piperaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014