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Analytical Performances and Clinical Impact of the Roche Cobas® Liat Influenza A/B & RSV Assay in the Management of Adult and Pediatric Patients Attending the Emergency Room

NCT ID: NCT05105191

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-03

Study Completion Date

2020-06-30

Brief Summary

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Molecular techniques for respiratory virus detection have already shown benefits in terms of sensitivity gained in comparison to conventional techniques. Recent progress has made it possible to shorten turnaround time (TAT) and to allow delivery of results in a timely manner, especially in comparison to cell culture and direct fluorescence assays (DFA). However, the cost of these molecular assays is usually not taken in charge by public health insurance system. This could be partly explained by the fact that molecular techniques have not clearly shown cost-effectiveness. Results of molecular tests for influenza viruses and RSV, if delivered rapidly, in the emergency room (ER), would most likely help avoid antibiotic use and ancillary test prescription, improve antiviral prescription and shorten length of stay in the ward by facilitating discharge or cohorting of hospitalized patients. The goal of this study is to assess the performances of Roche Cobas® Liat Influenza A/B \& RSV assay, to appraise its clinical impact and to evaluate its cost effectiveness.

Detailed Description

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Conditions

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Influenza Viral Infections RSV Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Roche Cobas® Liat Influenza A/B & RSV assay

Performance of a rapid molecular assay to diagnose influenza and RSV infections

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Either a pre-test indication of hospitalization
* or an underlying situation at risk of respiratory complication following influenza infection
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LHUB-ULB

UNKNOWN

Sponsor Role collaborator

Roche Diagnostics GmbH

INDUSTRY

Sponsor Role collaborator

Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Brugmann Hospital

Brussels, , Belgium

Site Status

Erasme Hospital

Brussels, , Belgium

Site Status

HUDERF

Brussels, , Belgium

Site Status

Saint-Pierre Hospital

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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SRB2019_401

Identifier Type: -

Identifier Source: org_study_id