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Clinical Trials/NCT02846311
NCT02846311CompletedNot Applicable

Prospective Evaluation of the Alere i Influenza A&B Nucleic Acid Amplification Versus Xpert Flu/RSV

Fondation Hôpital Saint-Joseph1 site in 1 country92 target enrollmentStarted: January 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
92
Locations
1
Primary Endpoint
Assessment of change of the Length of stay in the emergency service

Study Overview

Brief Summary

The rapid and accurate detection of influenza virus in respiratory specimens is required for optimal management of patients with acute respiratory infections. Because of the variability of the symptoms and the numerous other causes of influenza-like illness, the diagnosis of influenza cannot be made on the basis of clinical criteria alone. Thus, rapid influenza diagnostic tests have been developed such as the Alere i Influenza A&B isothermal nucleic acid assay. Investigators prospectively evaluated the performance of the Alere i Influenza A&B assay in comparison with the routine Xpert Flu/RSV assay.

Detailed Description

Main objective / secondary:

It appears that so far the weight of the influenza disease, the limits of clinical diagnosis and validity of rapid diagnostic methods to emergencies are well studied and validated. However the potential organizational and economic benefit in emergency care services remains little known and rarely evaluated.

The significant improvement in diagnostic response time he has a real beneficial impact for the patient? For the organization of the emergency? Investigators propose to study the impact of the implementation of rapid diagnostic solution by molecular biology of influenza directly available in an adult emergency department, from a cohort of patients consulting in connection a flu-like illness. Investigators wish in particular to highlight the organizational and economic impact.

Methodology :

DESIGN:

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Respiratory Symptoms include cough, dyspnea and / or
  • General symptoms: headache, myalgia, asthenia, anorexia ... and / or
  • Acute fever above 38 ° C
  • Patient consent.

Exclusion Criteria

  • Major cognitive disorders
  • Patient under guardianship
  • Patient refusing to consent to research
  • Duplicate (patients who have had laboratory diagnosis of influenza in previous 7 days)
  • Patient not receiving social security

Outcomes

Primary Outcomes

Assessment of change of the Length of stay in the emergency service

Time Frame: Day 1

Will be assessed with patients of the firt group (phase 1) and the second one (With Flu Test)

Assessment of change of Hospitalization rates

Time Frame: Day 1

Will be assessed with patients of the firt group (phase 1) and the second one (With Flu Test)

Secondary Outcomes

  • Assessments of change of antibiotic treatment Costs(Day1)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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