Detection of Microorganisms and Antibiotic Resistance Genes Using the Curetis Unyvero LRT55 Application

Status:	Completed
Conditions:	Pneumonia
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	3/7/2019
Start Date:	June 2015
End Date:	November 2016

Detection of Microorganisms and Antibiotic Resistance Genes in Lower Respiratory Tract (LRT) Samples Using the Curetis Unyvero LRT55 Application

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.

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.

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

We found this trial at

sites

Univ of Washington

Seattle, Washington 98104

(206) 543-2100