Detection of Microorganisms and Antibiotic Resistance Genes Using the Curetis UnyveroTM LRT Application

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Curetis AG
Information provided by (Responsible Party):
Curetis AG Identifier:
First received: August 7, 2013
Last updated: May 13, 2014
Last verified: May 2014

The Curetis UnyveroTM LRT Application is intended to detect and to identify genes of 17 microorganisms and 22 genes associated with antibiotic resistance in less than 4 hours.

In this study, the performance of the UnyveroTM LRT 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 PCRbased 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 UnyveroTM LRT Application and standard-of care.

Condition Intervention
Device: Tested Surplus Clinical Specimens

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 UnyveroTM LRT Application

Resource links provided by NLM:

Further study details as provided by Curetis AG:

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 9 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 Tracheal aspirate

Estimated Enrollment: 2000
Study Start Date: July 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tested Surplus Clinical Specimens
Patients with suspicion of lower respiratory tract infection (pneumonia)
Device: Tested Surplus Clinical Specimens
Testing on the Unyvero(TM)instrument

Detailed Description:

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.


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

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., D(ABMM)         
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: Kristi Cumming    248-435-4668   
Contact: Kimberly Powell    248-435-4668   
Principal Investigator: Matthew Sims, M.D., Ph.D.         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: David Lynch    507-266-4665   
Contact: Mary Karaus    5075388472   
Principal Investigator: Robin Patel, M.D.         
United States, New York
North Shore - LIJ Laboratories Recruiting
Lake Success, New York, United States, 11042
Contact: Debbie Korologos    516-719-1079   
Principal Investigator: Stephan Juretschko, Ph.D.         
Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: David Vicino    585-275-1621   
Principal Investigator: Dwight Hardy, Ph.D.         
United States, Pennsylvania
Geisinger Health System Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Diana Hernandex    570-214-9367   
Principal Investigator: Donna Wolk, Ph.D.         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Susan Butler-Wu, Ph.D., D(ABMM)    206-598-5449    butlerwu@uw.ed   
Principal Investigator: Susan Butler-Wu, Ph.D., D(ABMM)         
Sponsors and Collaborators
Curetis AG
Study Director: Anne Thews, M.D. Curetis AG
  More Information

No publications provided

Responsible Party: Curetis AG Identifier: NCT01922024     History of Changes
Other Study ID Numbers: CURETIS US 001
Study First Received: August 7, 2013
Last Updated: May 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents processed this record on August 19, 2014