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TGV:Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00263900
First received: December 8, 2005
Last updated: April 20, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention
Influenza
Respiratory Syncytial Viruses
 Device: RSV respi-strip and Quick-vue influenza

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Exploratory Study of the Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit and Their Impact on the Assumption of Responsibility of the Suspect Children of a Viral Infection

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • 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 Frame: time of support at the emergnecy unit ] [ Designated as safety issue: No ]

Enrollment: 377
Study Start Date: December 2005
Study Completion Date: June 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: RSV respi-strip and Quick-vue influenza
    Assessments of 2 quick diagnostic tests in the emergency unit during children's care
  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263900

Locations
France
Urgences pédiatriques
Amiens, France
Urgences pédiatriques CHU de Caen
Caen, France, 14033
POSU pediatrique
Le Havre, France, 76083
Urgences pédiatriques - CHU ROUEN
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Christophe MARGUET, Professor University Hospital, Rouen
  More Information

No publications provided

Responsible Party: Mr François TEILLARD, Research and Innovation Director, Direction de la Recherche et de l'Innovation
ClinicalTrials.gov Identifier: NCT00263900     History of Changes
Other Study ID Numbers: 2004/078/HP
Study First Received: December 8, 2005
Last Updated: April 20, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
Influenza A
Influenza B
RSV

Additional relevant MeSH terms:
Emergencies
Influenza, Human
Disease Attributes
Pathologic Processes
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013