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

Completed

Conditions studied: Pneumonia

In brief

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.

Key facts

Study ID

NCT01922024

Run by

Curetis GmbH

People needed

2124

Starts

2015-06-01

Expected to finish

2016-11-01

Last updated by the study team

2019-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hospitalized subjects with suspicion of lower respiratory tract infection
• Age at least 18 years
• Available surplus respiratory aspirate or bronchial lavage sample

You may not qualify if…

• Out-patient (ambulatory patient)
• Known infection with HIV, HBV or tuberculosis

Where it is running

• University of California Los Angeles (UCLA) — Los Angeles, California, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Columbia Universiy Medical Center / New York-Presbyterian Hosp. — New York, New York, United States
• Rochester Medical Center — Rochester, New York, United States
• Summa Health System — Akron, Ohio, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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