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

NCT02846311 | Completed DMC

• 1 other identifier: Test iFluA&B
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

test; winter; season

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Assessments of change of antibiotic treatment Costs

  Day1

Study Arms (2)

Group with support that will be usually performed

During the first phase ("before"), the assumption will be that usually achieved. The doctor continues to support according to information it has and according to good practice and service protocols.

Group with a flu test

During the second phase ("after"), a flu test is routinely performed within the home emergency department by the doctor who supports the patient. The doctor continues to support according to information it has and according to good practice and service protocols.

Device: Flu Test

Interventions

Flu Test DEVICE

Group with a flu test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients (\> 18 years) consultant to the ER for influenza-like illness involving

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• TRABATTONI Eloïse, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 27, 2016
• Study Start: January 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 27, 2023

Record last verified: 2016-07

Locations

FR (1)