NCT00329134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

April 17, 2009

Status Verified

April 1, 2009

Enrollment Period

10 months

First QC Date

May 22, 2006

Last Update Submit

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

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

Study Sites (1)

Centre Hospitalier De Butare

Butare, Rwanda

Location

Related Links

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 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

April 17, 2009

Record last verified: 2009-04

Locations

RW(1)