NCT00263900

Brief Summary

The aim of this study is to evaluate the impact of the use of a quick diagnostic test of infection with RSV and influenza virus on the assumption of clinical responsibility of the children consulting at the Paediatric Emergency Unit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
377

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

April 21, 2011

Status Verified

April 1, 2011

Enrollment Period

3.4 years

First QC Date

December 8, 2005

Last Update Submit

April 20, 2011

Conditions

InfluenzaRespiratory Syncytial Viruses

Keywords

Influenza AInfluenza BRSV

Outcome Measures

Primary Outcomes (1)

  • Assessments of quick diagnostic test of the Influenza virus and the SRV to measure the utility and the impact of those tests on the care of children in emergency unit

    time of support at the emergnecy unit

Interventions

RSV respi-strip and Quick-vue influenzaDEVICE

Assessments of 2 quick diagnostic tests in the emergency unit during children's care

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age less than 5 years
  • Isolated fever and/or
  • Infection of the higher air routes (congestive otitis, feverish rhinitides, tracheitis or laryngitis) and/or infection of the lower air routes (cough, pneumonia, bronchitis, asthma)
  • Signed consent form

You may not qualify if:

  • Evocative clinical of a urinary and/or bacterial infection
  • Purulent acute otitis media
  • Typical acute bronchiolitis
  • Suspicion of acute lobar pneumonia
  • Acute gastro-enteritis
  • Anginas
  • Serious chronic respiratory pathology
  • Other infection whose etiologic viral diagnosis is established
  • Congenital or acquired immunizing deficits
  • Congenital cardiopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Urgences pédiatriques

Amiens, France

Location

Urgences pédiatriques CHU de Caen

Caen, 14033, France

Location

POSU pediatrique

Le Havre, 76083, France

Location

Urgences pédiatriques - CHU ROUEN

Rouen, 76031, France

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Christophe MARGUET, Professor

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 8, 2005

First Posted

December 9, 2005

Study Start

December 1, 2005

Primary Completion

May 1, 2009

Study Completion

June 1, 2010

Last Updated

April 21, 2011

Record last verified: 2011-04

Locations

FR(4)