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

NCT05105191 | Terminated FDA Device

• 1 other identifier: SRB2019_401
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 4

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.

Conditions

Influenza Viral Infections; RSV Infection

Outcome Measures

Primary Outcomes (5)

• 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).

  through study completion, 6 months

• Hospital admission intentions

  Number of admission intentions before and after the test result

  through study completion, 6 months

• Isolation intentions

  Number of isolation intentions before and after the test result

  through study completion, 6 months

• Antibiotic prescription intentions

  Number of antibiotic prescription intentions before and after the test result

  through study completion, 6 months

• Antiviral treatment prescription intentions

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

  through study completion, 6 months

Interventions

Roche Cobas® Liat Influenza A/B & RSV assay DIAGNOSTIC_TEST

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Erasme University Hospital: lead
• LHUB-ULB: collaborator
• Roche Diagnostics GmbH: collaborator

Study Sites (4)

Brugmann Hospital

Brussels, Belgium

Location

Erasme Hospital

Brussels, Belgium

Location

HUDERF

Brussels, Belgium

Location

Saint-Pierre Hospital

Brussels, Belgium

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: November 3, 2021
• Study Start: February 3, 2020
• Primary Completion: March 9, 2020
• Study Completion: June 30, 2020
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

BE (4)