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

This study is currently recruiting participants.

Verified by University Hospital, Rouen, January 2008

Sponsored by:	University Hospital, Rouen
Information provided by:	University Hospital, 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 Viruses	Device: RSV respi-strip and Quick-vue influenza

MedlinePlus related topics: Flu

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study
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, 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 ]

Estimated Enrollment:	950
Study Start Date:	December 2005
Estimated Study Completion Date:	April 2008

Intervention Details:

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

Contacts

Contact: Christophe MARGUET, Professor

christophe.marguet@chu-rouen.fr

Locations

France
Urgences pédiatriques - CHU ROUEN	Recruiting
ROUEN, France, 76031
Contact: Christophe MARGUET christophe.marguet@chu-rouen.fr
Principal Investigator: Christophe MARGUET, PU-PH
Sub-Investigator: Marc LUBRANO, PH
Sub-Investigator: Martine GRALL-LEROSEY, PH
Sub-Investigator: Laure Seris, MD
POSU pediatrique	Recruiting
Le Havre, France, 76083
Principal Investigator: Pascal LE ROUX, PU-PH
Sub-Investigator: Damien DUFOUR, PH
Urgences pédiatriques CHU de Caen	Recruiting
Caen, France, 14033
Principal Investigator: Philippe ECKART, PH
Principal Investigator: Jacques BROUARD, PU-PH
Urgences pédiatriques	Recruiting
Amiens, France
Contact: Jean C Pautard, MD
Principal Investigator: Jean C Pautard, MD

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator:

Christophe MARGUET, Professor

University Hospital, Rouen

More Information

Study ID Numbers:	2004/078/HP
Study First Received:	December 8, 2005
Last Updated:	January 28, 2008
ClinicalTrials.gov Identifier:	NCT00263900
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Rouen:

Influenza A
Influenza B
RSV

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Emergencies
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections
Disease Attributes
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 16, 2009