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NCT00329134 Clinical Trial

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

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00329134
Other study ID # 2006/177
Secondary ID
Status Completed
Phase Phase 2
First received May 22, 2006
Last updated April 16, 2009
Start date July 2006
Est. completion date May 2007

Study information
Verified date April 2009
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 59 Months
Eligibility Inclusion Criteria:

- Malaria (falciparium malaria, uncomplicated)

- Informed consent

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Administration of quinine sulphate taste-masked pellets

Locations
Country Name City State
Rwanda Centre Hospitalier De Butare Butare

Sponsors (1)
Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Rwanda, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clocktime when child has had no fever for minimal 48h (< 37,5°C)
Primary Parasitemy
Secondary Plasma concentration of quinine at day 4 between first and second administration
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