NCT00845533

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
Last Updated

January 16, 2014

Status Verified

January 1, 2014

Enrollment Period

4 months

First QC Date

February 17, 2009

Last Update Submit

January 15, 2014

Conditions

Uncomplicated Malaria

Interventions

Dihydroartemisinin-PiperaquineDRUG

Eligibility Criteria

Age6 Months - 10 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • Positive screening thick blood smear
  • Fever (\> 37.5ºC axillary) or history of fever in the previous 24 hours
  • Age ≥ 6 months to 10 years
  • Weight \> 5 kg
  • Absence of any history of serious side effects to study medications
  • No evidence of a concomitant febrile illness in addition to malaria
  • No history of antimalarial use in the previous two weeks
  • P. falciparum mono-infection
  • Parasite density 2000-200,000/ul
  • Provision of informed consent and ability to participate in 42-day follow-up

You may not qualify if:

  • Danger signs or evidence of severe malaria
  • Hemoglobin levels \< 5.0 gm/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 18, 2009

Study Start

August 1, 2007

Primary Completion

December 1, 2007

Study Completion

January 1, 2009

Last Updated

January 16, 2014

Record last verified: 2014-01