Back to resultsTGV:Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit
Primary Purpose
Influenza, Respiratory Syncytial Viruses
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
RSV respi-strip and Quick-vue influenza
Sponsored by
About this trial
This is an interventional diagnostic trial for Influenza focused on measuring Influenza A, Influenza B, RSV
Eligibility 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
Sites / Locations
- Urgences pédiatriques
- Urgences pédiatriques CHU de Caen
- POSU pediatrique
- Urgences pédiatriques - CHU ROUEN
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00263900
First Posted
December 8, 2005
Last Updated
April 20, 2011
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT00263900
Brief Title
TGV:Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit
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 Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Respiratory Syncytial Viruses
Keywords
Influenza A, Influenza B, RSV
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
377 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
RSV respi-strip and Quick-vue influenza
Intervention Description
Assessments of 2 quick diagnostic tests in the emergency unit during children's care
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe MARGUET, Professor
Organizational Affiliation
University Hospital, Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urgences pédiatriques
City
Amiens
Country
France
Facility Name
Urgences pédiatriques CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
POSU pediatrique
City
Le Havre
ZIP/Postal Code
76083
Country
France
Facility Name
Urgences pédiatriques - CHU ROUEN
City
Rouen
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
Learn more about this trial
TGV:Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit
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