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

Detection of Microorganisms and Antibiotic Resistance Genes in Lower Respiratory Tract (LRT) Samples Using the Curetis Unyvero LRT55 Application

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia
• Intervention / Treatment: Device: LRT55 Testing

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.

• Study Type: Observational
• Enrollment (Actual): 2124

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90049
      • University of California Los Angeles (UCLA)
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55901
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10032
      • Columbia Universiy Medical Center / New York-Presbyterian Hosp.
    • Rochester, New York, United States, 14642
      • Rochester Medical Center
  • Ohio
    • Akron, Ohio, United States, 44304
      • Summa Health System
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Suspicion of lower respiratory tract infection in hospitalized subjects.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing	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.	Up to 12 months

Collaborators and Investigators

• Sponsor: Curetis GmbH
• Collaborators: Global BioClinical
• Investigators: Study Director: Johannes Bacher, Curetis GmbH

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (ACTUAL): November 1, 2016
• Study Completion (ACTUAL): November 1, 2016

Study Registration Dates

• First Submitted: August 7, 2013
• First Submitted That Met QC Criteria: August 12, 2013
• First Posted (ESTIMATE): August 14, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: CURETIS LRT55 Study - V 6.0