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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02846311
• Other study ID #: Test iFluA&B
• Status: Completed
• Start date: January 2015
• Est. completion date: April 2015

Study information

• Verified date: July 2016
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 single-center, prospective, descriptive, observational, type "before / after".

Unable to reasonably perform a prospective randomized study due to the constraints for patients and for the service and means that it would be necessary to deploy in this case (CRA ... PHRC), Methodology :

DESIGN:

Study single-center, prospective, descriptive, observational, type "before / after".

Unable to reasonably perform a prospective randomized study due to the constraints for patients and for the service and means that it would be necessary to deploy in this case (CRA ... PHRC), we are moving more towards a comparison study before / after between February and April.

Time study Total study duration: 3 months Inclusion period: 3 months (February 2016- April 2016)

Acquisition of data:

Data Observing Notebook (CRF or "Case Report Form") are disclosed in the notes accompanying this document and will be collected aur an Excel spreadsheet Statistical analysis ( For each subject will be awarded an identifier (original name and surname - year of birth) and the data will be entered on a computer file which will be sent to the statistician in charge of analyzing the GHPSJ site. There will be no exchange of personal data for this study is single center on the site GHPSJ.

Development of the study:

The patient presents to the Emergency Home Service for a "flu syndrome". During the first phase ( "before"), the assumption will be that usually achieved.

During the second phase ( "after"), a flu test is routinely performed within the home emergency department by the doctor who supports the patient.

In both cases, the doctor continues to support according to information it has and according to good practice and service protocols.

A case report form (CRF or Case Report Form) is completed for each patient included in the study. This report forms includes a questionnaire that collects anonymous demographic information (patient age and sex) and clinical data. The CRF also includes the results of the rapid test for influenza. These notebooks anonymous comments are seized by the Home Emergency Service on a type of database "Access" (which will then be completed by the results of the rapid test. If positive, strain characterization will be clarified.

Number of patients recruited (justification) and duration of participation for each patient:

Not applicable as observational study are moving more towards a comparison study before / after between February and April.

Time study Total study duration: 3 months Inclusion period: 3 months (February 2016- April 2016)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Respiratory Symptoms include cough, dyspnea and / or

2. General symptoms: headache, myalgia, asthenia, anorexia ... and / or

3. Acute fever above 38 ° C

4. 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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Device:
• Flu Test

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of change of the Length of stay in the emergency service	Will be assessed with patients of the firt group (phase 1) and the second one (With Flu Test)	Day 1
Primary	Assessment of change of Hospitalization rates	Will be assessed with patients of the firt group (phase 1) and the second one (With Flu Test)	Day 1
Secondary	Assessments of change of antibiotic treatment Costs	Will be assessed with patients of the firt group (phase 1) and the second one (With Flu Test)	Day1