Detection of Microorganisms and Antibiotic Resistance Genes Using the Curetis UnyveroTM LRT Application
The Curetis UnyveroTM LRT Application is intended to detect and to identify genes of 17 microorganisms and 22 genes associated with antibiotic resistance in less than 4 hours.
In this study, the performance of the UnyveroTM LRT 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 PCRbased 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 UnyveroTM LRT Application and standard-of care.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Detection of Microorganisms and Antibiotic Resistance Genes in Lower Respiratory Tract (LRT) Samples, Using the Curetis UnyveroTM LRT Application|
- Clinical sensitivity and specificity for microorganism detection as compared to routine microbiology and other reference methods including PCR and sequencing [ Time Frame: up to 9 months ] [ Designated as safety issue: No ]Sensitivity for microorganism detection will be determined against the respective reference method consisting of standard procedure and/or a reference method based on PCR and bi-directional sequencing using alternative primers. Sensitivity for non-atypical microorganism detection will thus be determined if at least 1 out of 2 reference methods have identified microorganisms that are covered by the panel of the investigational IVD. Results will further be analyzed against standard of-care alone, as well as against composite comparator. Sensitivity for atypical microorganism detection will be determined against PCR with alternative primers as reference method. Specificity for microorganism detection will be determined in all samples included in the trial. Individual specificities will be calculated for the detection of the respiratory microorganisms analyzed by the investigational IVD compared to the microorganisms reference method.
Biospecimen Retention: Samples With DNA
Bronchial lavage Tracheal aspirate
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Tested Surplus Clinical Specimens
Patients with suspicion of lower respiratory tract infection (pneumonia)
Device: Tested Surplus Clinical Specimens
Testing on the Unyvero(TM)instrument
This is a non-interventional, controlled, non-randomized multicenter clinical study that compares a new diagnostic device, the UnyveroTM LRT 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 UnyveroTM LRT Application will not be made available to the treating physician and therefore will not be used for diagnosis, treatment or other management decisions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01922024
|United States, California|
|University of California Los Angeles (UCLA)|
|Los Angeles, California, United States, 90049|
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55901|
|United States, New York|
|North Shore - LIJ Laboratories|
|Lake Success, New York, United States, 11042|
|Rochester Medical Center|
|Rochester, New York, United States, 14642|
|United States, Pennsylvania|
|Geisinger Health System|
|Danville, Pennsylvania, United States, 17822|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Study Director:||Anne Thews, M.D.||Curetis AG|