This trial has been completed.

Condition pneumonia
Treatment lrt55 testing
Sponsor Curetis GmbH
Collaborator Global BioClinical
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

Study Design

Observational model cohort
Time perspective prospective
Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against composite (comparator) which is based on routine clinical microbiology and a second PCR test
lrt55 testing
Testing on the Unyvero LRT55
Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against routine clinical microbiology
lrt55 testing
Testing on the Unyvero LRT55

Primary Outcomes

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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Curetis GmbH.