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

Phase 2

Completed

• Conditions: Malaria

• Registration Number: NCT00329134
• Lead Sponsor: University Ghent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-05-22
• Study First Submitted QC: 2006-05-22
• Study First Posted: 2006-05-24
• Study Start: 2006-07
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-16
• Last Update Posted: 2009-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Malaria (falciparium malaria, uncomplicated)
• Informed consent

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of quinine at day 4 between first and second administration

Trial Locations

Locations (1)

Centre Hospitalier De Butare; 🇷🇼 Butare, Rwanda