drugset / Trial / NCT00329134

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

NCT00329134

Phase 2 Completed 56 enrolled University Ghent
RandomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2006-07
Primary completion
2007-05
Completion
2007-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Quinine Small molecule 10 mg/kg
Subject Quinine Small molecule 15 mg/kg