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Clinical Trials/NCT00329134
NCT00329134CompletedPhase 2

Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria

University Ghent1 site in 1 country56 target enrollmentStarted: July 1, 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
56
Locations
1
Primary Endpoint
Clocktime when child has had no fever for minimal 48h (< 37,5°C)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No pediatric formulations of quinine exist. Therefore, quinine tablets are broken into 2 or 4 parts, according to the body weight. Based on the body weight, 1/2 or 1/4 a tablet is administered to the child.

At this moment, quinine sulphate pellets are developed. These pellets enable an adequate dosing according to the body weight.

56 children with malaria will be dosed every 8 hours during 7 days with 10-15mg/kg body weight.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
6 Months to 59 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Malaria (falciparium malaria, uncomplicated)
  • •Informed consent

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Clocktime when child has had no fever for minimal 48h (< 37,5°C)

Parasitemy

Secondary Outcomes

  • Plasma concentration of quinine at day 4 between first and second administration

Investigators

Sponsor Class
Other

Study Sites (1)

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