Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Parasitic Diseases
Protozoan Infections
Artemisinins
Dihydroartemisinin
Piperaquine
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014