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

Tracking Information

First Received Date ^ICMJE

May 22, 2006

Last Updated Date

April 16, 2009

Start Date ^ICMJE

July 2006

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clocktime when child has had no fever for minimal 48h (< 37,5°C)
Parasitemy

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00329134 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Plasma concentration of quinine at day 4 between first and second administration

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Malaria

Intervention ^ICMJE

Drug: Administration of quinine sulphate taste-masked pellets

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

May 2007

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Malaria (falciparium malaria, uncomplicated)
Informed consent

Exclusion Criteria:

Gender

Both

Ages

6 Months to 59 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Rwanda

Administrative Information

NCT ID ^ICMJE

NCT00329134

Responsible Party

Jean Paul Remon, University Ghent

Study ID Numbers ^ICMJE

2006/177

Study Sponsor ^ICMJE

University Ghent

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Luc Van Bortel, MD, PhD

University Hospital, Ghent

Information Provided By

University Ghent

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP