NCT05105191|TerminatedFDA Device
Study Stopped
COVID-19 pandemic introduced a confusion bias
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Sponsor study identifier
interventional
280
1 country
4
Study Start
February 3, 2020
Actual (reported)Primary Completion
March 9, 2020
Actual (reported)Study Completion
June 30, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 3, 2020
Actual (reported)March 9, 2020
Actual (reported)June 30, 2020
Actual (reported)September 29, 2021
Actual (reported)November 3, 2021
Actual (reported)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
Performance of a rapid molecular assay to diagnose influenza and RSV infections
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Brugmann Hospital
Brussels, Belgium
Erasme Hospital
Brussels, Belgium
HUDERF
Brussels, Belgium
Saint-Pierre Hospital
Brussels, Belgium
280 participants (actual enrollment reported by the registry).
First Submitted
September 29, 2021
First Posted
November 3, 2021
Study Start
February 3, 2020
Actual (reported)Hypothesizing the Genesis of Infectious Diseases and Epidemics Through an Integrated Systems Biology Approach
through study completion, 6 months
Primary Completion
March 9, 2020
Actual (reported)Study Completion
June 30, 2020
Actual (reported)Last Updated
November 3, 2021
Record last verified: 2021-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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