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

This study has been completed.

First Received: May 22, 2006 Last Updated: April 16, 2009 History of Changes

Sponsor:	University Ghent
Information provided by:	University Ghent
ClinicalTrials.gov Identifier:	NCT00329134

Purpose

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.

Condition	Intervention	Phase
Malaria	Drug: Administration of quinine sulphate taste-masked pellets	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria

Resource links provided by NLM:

MedlinePlus related topics: Malaria Taste and Smell Disorders

Drug Information available for: Quinine hydrochloride Quinine Quinine bisulfate Quinine Sulfate

U.S. FDA Resources

Further study details as provided by University Ghent:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	56
Study Start Date:	July 2006
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	6 Months to 59 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Malaria (falciparium malaria, uncomplicated)
Informed consent

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329134

Locations

Rwanda
Centre Hospitalier De Butare
Butare, Rwanda

Sponsors and Collaborators

University Ghent

Investigators

Principal Investigator:

Luc Van Bortel, MD, PhD

University Hospital, Ghent

More Information

Additional Information:

Website University Hospital Ghent This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University Ghent ( Jean Paul Remon )
Study ID Numbers:	2006/177
Study First Received:	May 22, 2006
Last Updated:	April 16, 2009
ClinicalTrials.gov Identifier:	NCT00329134 History of Changes
Health Authority:	Belgium: Institutional Review Board

Additional relevant MeSH terms:

Protozoan Infections
Anti-Infective Agents
Antiprotozoal Agents
Coccidiosis
Quinine
Physiological Effects of Drugs
Neuromuscular Agents
Malaria
Pharmacologic Actions
Malaria, Falciparum

Antimalarials
Antiparasitic Agents
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Muscle Relaxants, Central
Parasitic Diseases
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 22, 2009