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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:
ClinicalTrials.gov Identifier:
NCT00263900
First Posted: December 9, 2005
Last Update Posted: April 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Rouen
  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
Intervention Model: Crossover Assignment
Masking: None (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:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 8, 2005
First Posted: December 9, 2005
Last Update Posted: April 21, 2011
Last Verified: April 2011

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

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