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

NCT ID: NCT00329134

Last Updated: 2009-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-05-31

Brief Summary

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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

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Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Administration of quinine sulphate taste-masked pellets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Malaria (falciparium malaria, uncomplicated)
* Informed consent

Exclusion Criteria

\-
Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Ghent

OTHER

Sponsor Role lead

Responsible Party

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University Ghent

Principal Investigators

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Luc Van Bortel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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Centre Hospitalier De Butare

Butare, , Rwanda

Site Status

Countries

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Rwanda

Related Links

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http://www.uzgent.be

Website University Hospital Ghent

Other Identifiers

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2006/177

Identifier Type: -

Identifier Source: org_study_id

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