Detection of Microorganisms and Antibiotic Resistance Genes in Lower Respiratory Tract (LRT) Samples, Using the Curetis UnyveroTM LRT Application


Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

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

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