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

January 15, 2014 updated by: Sunil Parikh, University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 10 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Mahidol University
Holley-Cotec Pharmaceuticals Co., LTD.

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Estimate)

January 16, 2014

Last Update Submitted That Met QC Criteria

January 15, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H40380-31179-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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