Back to resultsInvestigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria
Primary Purpose
Malaria
Status
Completed
Phase
Phase 2
Locations
Rwanda
Study Type
Interventional
Intervention
Administration of quinine sulphate taste-masked pellets
Sponsored by
About this trial
This is an interventional treatment trial for Malaria
Eligibility Criteria
Inclusion Criteria: Malaria (falciparium malaria, uncomplicated) Informed consent Exclusion Criteria: -
Sites / Locations
- Centre Hospitalier De Butare
Outcomes
Primary Outcome Measures
Clocktime when child has had no fever for minimal 48h (< 37,5°C)
Parasitemy
Secondary Outcome Measures
Plasma concentration of quinine at day 4 between first and second administration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00329134
Brief Title
Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria
Official Title
Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Administration of quinine sulphate taste-masked pellets
Primary Outcome Measure Information:
Title
Clocktime when child has had no fever for minimal 48h (< 37,5°C)
Title
Parasitemy
Secondary Outcome Measure Information:
Title
Plasma concentration of quinine at day 4 between first and second administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Malaria (falciparium malaria, uncomplicated)
Informed consent
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Van Bortel, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier De Butare
City
Butare
Country
Rwanda
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent
Learn more about this trial
Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria
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