Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria
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.
|Malaria||Drug: Administration of quinine sulphate taste-masked pellets||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria|
- Clocktime when child has had no fever for minimal 48h (< 37,5°C)
- Plasma concentration of quinine at day 4 between first and second administration
|Study Start Date:||July 2006|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329134
|Centre Hospitalier De Butare|
|Principal Investigator:||Luc Van Bortel, MD, PhD||University Hospital, Ghent|