NCT00329134

CompletedPhase 2

Investigation of the Efficacy of Quinine Sulphate Administer...

University Ghent Source

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Other study identifiers

Sponsor study identifier

2006/177

Study Type

interventional

Estimated enrollment

56

Locations

1 country

Sites

1

Timeline

Study Start

July 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

May 2007

Actual (reported)

Study Completion

May 2007

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 56 participants
Study completion date: May 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
May 22, 2006
Actual (reported)
First Posted
May 24, 2006
Actual (reported)
Study Start
July 2006
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
May 2007
Actual (reported)
Study Completion
May 2007
Actual (reported)

Last Updated: April 17, 2009
Status Verified: April 2009
Last Update Submitted: April 16, 2009

Conditions

Malaria

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (1)

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

Interventions

Administration of quinine sulphate taste-masked pelletsDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age6 Months - 59 Months

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Malaria (falciparium malaria, uncomplicated)
Informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University Ghent
Otherlead

Study Sites (1)

Centre Hospitalier De Butare

Butare, Rwanda

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

Luc Van Bortel, MD, PhD
University Hospital, Ghent
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER

Study Record Dates

First Submitted

May 22, 2006

First Posted

May 24, 2006

Study Start

July 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

May 2007

Actual (reported)

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Study Completion

May 2007

Actual (reported)

Last Updated

April 17, 2009

Record last verified: 2009-04

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00329134
Data provider: ClinicalTrials.gov
Source updated: 2009-04-17
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:43 UTC

Locations

RW(1)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations