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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Curetis GmbH
Global BioClinical
Information provided by (Responsible Party):
Curetis GmbH Identifier:
First received: August 7, 2013
Last updated: February 29, 2016
Last verified: February 2016

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.

Condition Intervention
Device: LRT55 Testing

Study Type: Observational
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 Unyvero LRT55 Application

Resource links provided by NLM:

Further study details as provided by Curetis GmbH:

Primary Outcome Measures:
  • 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 ] [ 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 (BAL) Tracheal aspirate (TA)

Estimated Enrollment: 1500
Study Start Date: June 2015
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Prospective Fresh Clinical Specimens
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
Device: LRT55 Testing
Testing on the Unyvero LRT55
Retrospective Frozen Clinical Specimens
Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against routine clinical microbiology
Device: LRT55 Testing
Testing on the Unyvero LRT55

Detailed 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Suspicion of lower respiratory tract infection in hospitalized subjects.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01922024

Contact: Neil R. Mucci 2063886216

United States, California
University of California Los Angeles (UCLA) Recruiting
Los Angeles, California, United States, 90049
Contact: Janet Hindler    310-794-2749   
Principal Investigator: Romney Humphries, PhD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Chao Qi, Ph.D.    312-926-2181   
Principal Investigator: Richard Wunderink, M.D.         
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Tracy Howard    410-955-6510   
Principal Investigator: Karen Carroll, M.D.         
United States, Michigan
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Cindy Karl    248-551-4603   
Contact: Kimberly Powell    248-551-2685   
Principal Investigator: Matthew Sims, M.D., Ph.D.         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Jill Thorvilson    507-284-3675   
Contact: Brandon Messmer    5075388472   
Principal Investigator: Robin Patel, M.D.         
United States, New York
Columbia Universiy Medical Center / New York-Presbyterian Hosp. Recruiting
New York, New York, United States, 10032
Contact: Fann Wu    212-305-6706   
Contact: Rachel Wywadis    212-305-4034   
Principal Investigator: Fann Wu, D(ABCC)         
Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: David Vicino    585-275-1621   
Principal Investigator: Dwight Hardy, Ph.D.         
United States, Ohio
Summa Health System Recruiting
Akron, Ohio, United States, 44304
Contact: Jackie Beach    330-375-3787   
Principal Investigator: George Kallstrom, PhD, D(ABMM)         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Lauren Curtis    206-598-6147   
Principal Investigator: Brad Cookson, MD, PhD         
Sponsors and Collaborators
Curetis GmbH
Global BioClinical
Study Director: Johannes Bacher Curetis GmbH
  More Information

Responsible Party: Curetis GmbH Identifier: NCT01922024     History of Changes
Other Study ID Numbers: CURETIS LRT55 Study - V 6.0 
Study First Received: August 7, 2013
Last Updated: February 29, 2016
Health Authority: United States: Food and Drug Administration processed this record on April 27, 2016