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

April 16, 2009 updated by: University Ghent

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Rwanda
      • Butare, Rwanda
        • Centre Hospitalier De Butare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Malaria (falciparium malaria, uncomplicated)
  • Informed consent

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Investigators

  • Principal Investigator: Luc Van Bortel, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

May 22, 2006

First Submitted That Met QC Criteria

May 22, 2006

First Posted (Estimate)

May 24, 2006

Study Record Updates

Last Update Posted (Estimate)

April 17, 2009

Last Update Submitted That Met QC Criteria

April 16, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006/177

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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