Detection of Microorganisms and Antibiotic Resistance Genes Using the Curetis Unyvero LRT55 Application
This trial has been completed.
|Start date||June 2015|
|End date||November 2016|
|Trial size||1500 participants|
|Trial identifier||NCT01922024, CURETIS LRT55 Study - V 6.0|
The Curetis Unyvero LRT55 Application is intended to detect and to identify genes of 21 microorganisms and 19 genes associated with antibiotic resistance in 4 hours.
In this study, the performance of the Unyvero LRT55 Application shall be tested under clinical conditions and compared to (1) a composite reference method (for non-atypical or cultured microorganisms) or (2) a molecular PCR based reference method for the 3 atypical microorganisms Chlamydophila pneumoniae, Legionella pneumoniae, and Pneumocystis jirovecii, and for resistance genes.
PCR amplifications are followed by bi-directional sequencing, including comparison of the test results Time to result will be compared for the Unyvero LRT55 Application and standard-of care.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Los Angeles, CA||University of California Los Angeles (UCLA)||completed|
|Chicago, IL||Northwestern Memorial Hospital||completed|
|Baltimore, MD||Johns Hopkins Hospital||completed|
|Royal Oak, MI||William Beaumont Hospital||completed|
|Rochester, MN||Mayo Clinic||completed|
|New York, NY||Columbia Universiy Medical Center / New York-Presbyterian Hosp.||completed|
|Rochester, NY||Rochester Medical Center||completed|
|Akron, OH||Summa Health System||completed|
|Seattle, WA||University of Washington||completed|
Clinical sensitivity and specificity for microorganism detection as compared to routine microbiology and other reference methods including PCR and sequencing
time frame: Up to 12 months
Male or female participants at least 18 years old.
Inclusion Criteria: - Hospitalized subjects with suspicion of lower respiratory tract infection - Age at least 18 years - Available surplus respiratory aspirate or bronchial lavage sample Exclusion Criteria: - Out-patient (ambulatory patient) - Known infection with HIV, HBV or tuberculosis
|Official title||Detection of Microorganisms and Antibiotic Resistance Genes in Lower Respiratory Tract (LRT) Samples Using the Curetis Unyvero LRT55 Application|
|Description||This is a non-interventional, controlled, non-randomized multicenter clinical study that compares a new diagnostic device, the Unyvero LRT55 Application (based on molecular diagnostic methods) to either (1) a composite reference method (for non-atypical microorganisms), (2) a composite PCR-based method for 3 atypical microorganisms or (3) a PCR-based reference method for resistance genes. The study will use leftover lower respiratory tract samples taken from subjects suspected with lower respiratory tract infections: (a) Specimens taken prospectively for standard-of-care (i.e. microbiology testing) from hospitalized subjects. (b) Banked specimens for rare microorganisms. As the device is under investigation, the test results provided by the Unyvero LRT55 Application will not be made available to the treating physician and therefore will not be used for diagnosis, treatment or other management decisions.|
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