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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

December 8, 2005
April 20, 2011
December 2005
May 2009   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00263900 on ClinicalTrials.gov Archive Site
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TGV:Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit
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

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.
Not Provided
Interventional
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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Influenza
  • Respiratory Syncytial Viruses
Device: RSV respi-strip and Quick-vue influenza
Assessments of 2 quick diagnostic tests in the emergency unit during children's care
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
377
June 2010
May 2009   (final data collection date for primary outcome measure)

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
Both
up to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00263900
2004/078/HP
No
Mr François TEILLARD, Research and Innovation Director, Direction de la Recherche et de l'Innovation
University Hospital, Rouen
Not Provided
Principal Investigator: Christophe MARGUET, Professor University Hospital, Rouen
University Hospital, Rouen
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP