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

NCT00845533 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2014-01-16

No results posted yet for this study

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.

Conditions

  • Uncomplicated Malaria

Interventions

DRUG

Dihydroartemisinin-Piperaquine

Sponsors & Collaborators

Principal Investigators

  • Sunil Parikh, M.D., M.P.H. · University of California, San Francisco

  • Philip J Rosenthal, M.D. · University of California, San Francsico

  • Jean-Bosco Ouedraogo, M.D., PhD · Institut de Receherche en Sciences de la Sante Bobo-Dioulasso

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2007-12-31
Completion
2009-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00845533 on ClinicalTrials.gov