Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria
Information source: University Ghent
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria
Intervention: Administration of quinine sulphate taste-masked pellets (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University Ghent Official(s) and/or principal investigator(s):
Luc Van Bortel, MD, PhD, Principal Investigator, Affiliation: University Hospital, Ghent
Overall contact:
Jean-Paul Remon, PhD, Phone: 0032/(0)9/264.80.54, Email: jeanpaul.remon@UGent.be
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: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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
Jean-Paul Remon, PhD, Phone: 0032/(0)9/264.80.54, Email: jeanpaul.remon@UGent.be
Centre Hospitalier De Butare, Butare, Rwanda; Recruiting
Jean-Paul Remon, PhD, Phone: 0032/(0)9/264.80.54, Email: jeanpaul.remon@UGent.be
Marc Twagirumukiza, MD, Principal Investigator
Additional Information
Website University Hospital Ghent
Last updated: December 19, 2007
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