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NCT00263900 Clinical Trial

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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00263900
Other study ID # 2004/078/HP
Secondary ID
Status Completed
Phase N/A
First received December 8, 2005
Last updated April 20, 2011
Start date December 2005
Est. completion date June 2010

Study information
Verified date April 2011
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 377
Est. completion date June 2010
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group N/A to 5 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Urgences pédiatriques Amiens
France Urgences pédiatriques CHU de Caen Caen
France POSU pediatrique Le Havre
France Urgences pédiatriques - CHU ROUEN Rouen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 of support at the emergnecy unit No
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