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

Not Applicable

Terminated

• Conditions: RSV Infection; Influenza Viral Infections

• Registration Number: NCT05105191
• Lead Sponsor: Erasme University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-03
• Primary Completion: 2020-03-09
• Study Completion: 2020-06-30
• Study First Submitted: 2021-09-29
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-21
• Last Update Submitted: 2021-10-21
• Study First Posted: 2021-11-03
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Analytical performance (Sensitivity/Specificity)	through study completion, 6 months	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	through study completion, 6 months	Number of admission intentions before and after the test result
Isolation intentions	through study completion, 6 months	Number of isolation intentions before and after the test result
Antibiotic prescription intentions	through study completion, 6 months	Number of antibiotic prescription intentions before and after the test result
Antiviral treatment prescription intentions	through study completion, 6 months	Number of antiviral treatments prescription intentions before and after the test result

Trial Locations

Locations (4)

Erasme Hospital; 🇧🇪 Brussels, Belgium

Brugmann Hospital; 🇧🇪 Brussels, Belgium

Saint-Pierre Hospital; 🇧🇪 Brussels, Belgium

HUDERF; 🇧🇪 Brussels, Belgium