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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Curetis AG
ClinicalTrials.gov Identifier:
NCT01922024
First received: August 7, 2013
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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
Pneumonia
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: June 2016
Estimated Primary Completion Date: June 2016 (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.

  Eligibility

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.

Criteria

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 ClinicalTrials.gov identifier: NCT01922024

Locations
United States, California
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90049
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55901
United States, New York
North Shore - LIJ Laboratories
Lake Success, New York, United States, 11042
Rochester Medical Center
Rochester, New York, United States, 14642
United States, Pennsylvania
Geisinger Health System
Danville, Pennsylvania, United States, 17822
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Curetis AG
Investigators
Study Director: Anne Thews, M.D. Curetis AG
  More Information

No publications provided

Responsible Party: Curetis AG
ClinicalTrials.gov Identifier: NCT01922024     History of Changes
Other Study ID Numbers: CURETIS US 001
Study First Received: August 7, 2013
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 18, 2014