Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria
Information source: University Ghent
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria
Intervention: Administration of quinine sulphate taste-masked pellets (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University Ghent Official(s) and/or principal investigator(s): Luc Van Bortel, MD, PhD, Principal Investigator, Affiliation: University Hospital, Ghent
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.
Clinical Details
Official title: Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clocktime when child has had no fever for minimal 48h (< 37,5°C)Parasitemy
Secondary outcome: Plasma concentration of quinine at day 4 between first and second administration
Eligibility
Minimum age: 6 Months.
Maximum age: 59 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Malaria (falciparium malaria, uncomplicated)
- Informed consent
Exclusion Criteria:
-
Locations and Contacts
Centre Hospitalier De Butare, Butare, Rwanda
Additional Information
Website University Hospital Ghent
Starting date: July 2006
Last updated: April 16, 2009
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