Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00329134|
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : April 17, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Drug: Administration of quinine sulphate taste-masked pellets||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329134
|Centre Hospitalier De Butare|
|Principal Investigator:||Luc Van Bortel, MD, PhD||University Hospital, Ghent|