Detection of Microorganisms and Antibiotic Resistance Genes Using the Curetis Unyvero LRT55 Application
LRT55
1 other identifier
observational
2,124
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2015
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2013
CompletedFirst Posted
Study publicly available on registry
August 14, 2013
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedResults Posted
Study results publicly available
March 5, 2019
CompletedMarch 5, 2019
February 1, 2019
1.4 years
August 7, 2013
January 25, 2017
February 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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
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
Interventions
Testing on the Unyvero LRT55
Eligibility Criteria
Suspicion of lower respiratory tract infection in hospitalized subjects.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Curetis GmbHlead
- Global BioClinicalcollaborator
Study Sites (9)
University of California Los Angeles (UCLA)
Los Angeles, California, 90049, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Mayo Clinic
Rochester, Minnesota, 55901, United States
Columbia Universiy Medical Center / New York-Presbyterian Hosp.
New York, New York, 10032, United States
Rochester Medical Center
Rochester, New York, 14642, United States
Summa Health System
Akron, Ohio, 44304, United States
University of Washington
Seattle, Washington, 98195, United States
Biospecimen
Bronchial lavage (BAL) Tracheal aspirate (TA)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Operations
- Organization
- Curetis USA, Inc.
Study Officials
- STUDY DIRECTOR
Johannes Bacher
Curetis GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2013
First Posted
August 14, 2013
Study Start
June 1, 2015
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
March 5, 2019
Results First Posted
March 5, 2019
Record last verified: 2019-02