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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

Page last updated: August 23, 2015

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