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

RSV Infection Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05105191
• Other study ID #: SRB2019_401
• Status: Terminated
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: October 2021
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 280
• Est. completion date: June 30, 2020
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Either a pre-test indication of hospitalization

• or an underlying situation at risk of respiratory complication following influenza infection

Related Conditions & MeSH terms

• Communicable Diseases
• Emergencies
• Infections
• Influenza Viral Infections
• Influenza, Human
• Respiratory Syncytial Virus Infections
• RSV Infection
• Virus Diseases

Intervention

Diagnostic Test:
• Roche Cobas® Liat Influenza A/B & RSV assay
Performance of a rapid molecular assay to diagnose influenza and RSV infections

Locations

Country	Name	City	State
Belgium	Brugmann Hospital	Brussels
Belgium	Erasme Hospital	Brussels
Belgium	HUDERF	Brussels
Belgium	Saint-Pierre Hospital	Brussels

Sponsors (3)

Lead Sponsor	Collaborator
Erasme University Hospital	LHUB-ULB, Roche Diagnostics

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Hospital admission intentions	Number of admission intentions before and after the test result	through study completion, 6 months
Primary	Isolation intentions	Number of isolation intentions before and after the test result	through study completion, 6 months
Primary	Antibiotic prescription intentions	Number of antibiotic prescription intentions before and after the test result	through study completion, 6 months
Primary	Antiviral treatment prescription intentions	Number of antiviral treatments prescription intentions before and after the test result	through study completion, 6 months