AzTrials
AzTrials

Influenza Viral InfectionsNCT05105191

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

A study testing Roche Cobas® Liat Influenza A/B & RSV assay in people with Influenza Viral Infections and RSV Infection, run by Erasme University Hospital at 4 sites in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Influenza Viral Infections, RSV Infection
What is being tested?
Roche Cobas® Liat Influenza A/B & RSV assay
How many people
280 participants
Where
4 sitesBelgium
Study dates
3 Feb 2020to 30 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

4 sites in 1 country.

Belgium4 sites

  • Brugmann Hospital

    Brussels

  • Erasme Hospital

    Brussels

  • HUDERF

    Brussels

  • Saint-Pierre Hospital

    Brussels

Other trials in Belgium

About this study

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.

Being tested
Roche Cobas® Liat Influenza A/B & RSV assay
Medical subject headings
Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Roche Cobas® Liat Influenza A/B & RSV assayDiagnostic test

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: through study completion, 6 months

  2. Hospital admission intentions

    Number of admission intentions before and after the test result

    Measured: through study completion, 6 months

  3. Isolation intentions

    Number of isolation intentions before and after the test result

    Measured: through study completion, 6 months

  4. Antibiotic prescription intentions

    Number of antibiotic prescription intentions before and after the test result

    Measured: through study completion, 6 months

  5. Antiviral treatment prescription intentions

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

    Measured: through study completion, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2021
  2. Study start3 Feb 2020
  3. Primary completion9 Mar 2020
  4. Study completion30 Jun 2020

Why it stopped: COVID-19 pandemic introduced a confusion bias

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05105191
Sponsor's protocol ID
SRB2019_401
Status last verified
Oct 2021
First submitted
29 Sep 2021
Last updated
3 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Roche Cobas® Liat Influenza A/B & RSV assay in people with Influenza Viral Infections and RSV Infection, run by Erasme University Hospital at 4 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: COVID-19 pandemic introduced a confusion bias). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analytical performance (Sensitivity/Specificity) (time frame: through study completion, 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05105191.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in