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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

Primary Purpose

Influenza Viral Infections, RSV Infection

Status

Terminated

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Roche Cobas® Liat Influenza A/B & RSV assay

About this trial

This is an interventional diagnostic trial for Influenza Viral Infections

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

Brugmann Hospital
Erasme Hospital
HUDERF
Saint-Pierre Hospital

Outcomes

Primary Outcome Measures

Analytical performance (Sensitivity/Specificity)

Calculation of sensitivity and specificity of the test versus a composite reference standard. Samples are considered as positive for a viral pathogen if testing positive for this viral pathogen by at least 2 of the 3 techniques used, negative if tested negative by at least 2 of the 3 techniques (culture, antigen detection and PCR test).

Hospital admission intentions

Number of admission intentions before and after the test result

Isolation intentions

Number of isolation intentions before and after the test result

Antibiotic prescription intentions

Number of antibiotic prescription intentions before and after the test result

Antiviral treatment prescription intentions

Number of antiviral treatments prescription intentions before and after the test result

Secondary Outcome Measures

Full Information

NCT ID

NCT05105191

First Posted

September 29, 2021

Last Updated

October 21, 2021

Sponsor

Erasme University Hospital

Collaborators

LHUB-ULB, Roche Diagnostics

1. Study Identification

Unique Protocol Identification Number

NCT05105191

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Terminated

Why Stopped

COVID-19 pandemic introduced a confusion bias

Study Start Date

February 3, 2020 (Actual)

Primary Completion Date

March 9, 2020 (Actual)

Study Completion Date

June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Erasme University Hospital

Collaborators

LHUB-ULB, Roche Diagnostics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza Viral Infections, RSV Infection

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

280 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Diagnostic Test

Intervention Name(s)

Roche Cobas® Liat Influenza A/B & RSV assay

Intervention Description

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

Primary Outcome Measure Information:

Title

Analytical performance (Sensitivity/Specificity)

Description

Time Frame