Clinical Trial: TGV Study: Study of the Use of the Quick Diagnostic Test of Influenza and Infection With Respiratory Syncytial Virus (RSV)

This study is not yet open for patient recruitment.
Verified by University Hospital of Rouen December 2005

Sponsored by: University Hospital of Rouen
Information provided by: University Hospital of Rouen
ClinicalTrials.gov Identifier: NCT00263900

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 Virus Infections
 Device: RSV respi-strip and Quick-vue influenza

MedlinePlus related topics:  Flu;   Respiratory Syncytial Virus Infections

Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label

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

Further study details as provided by University Hospital of Rouen:

Expected Total Enrollment:  950

Study start: December 2005

Eligibility

Ages Eligible for Study:  up to  3 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Age less than 3 years
  • Isolated fever
  • 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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00263900

Christophe MARGUET, Professor       christophe.marguet@chu-rouen.fr

France
      CHU ROUEN, Rouen,  76031,  France
Christophe MARGUET   christophe.marguet@chu-rouen.fr 

Study chairs or principal investigators

Christophe MARGUET, Professor,  Principal Investigator,  University Hospital of Rouen   

More Information

Study ID Numbers:  2004/078/HP
Last Updated:  December 22, 2005
Record first received:  December 8, 2005
ClinicalTrials.gov Identifier:  NCT00263900
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2006-01-10

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