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

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. Identifier: NCT00263900
Recruitment Status : Completed
First Posted : December 9, 2005
Last Update Posted : April 21, 2011
Information provided by:
University Hospital, Rouen

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 377 participants
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
Study Start Date : December 2005
Primary Completion Date : May 2009
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Device: RSV respi-strip and Quick-vue influenza
    Assessments of 2 quick diagnostic tests in the emergency unit during children's care

Primary Outcome Measures :
  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 Frame: time of support at the emergnecy unit ]

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

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

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 identifier (NCT number): NCT00263900

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
Principal Investigator: Christophe MARGUET, Professor University Hospital, Rouen

Responsible Party: Mr François TEILLARD, Research and Innovation Director, Direction de la Recherche et de l'Innovation Identifier: NCT00263900     History of Changes
Other Study ID Numbers: 2004/078/HP
First Posted: December 9, 2005    Key Record Dates
Last Update Posted: April 21, 2011
Last Verified: April 2011

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

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