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

Pneumonia Clinical Trial

— LRT55  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922024
• Other study ID #: CURETIS LRT55 Study - V 6.0
• Status: Completed
• Start date: June 2015
• Est. completion date: November 2016

Study information

• Verified date: February 2019
• Source: Curetis GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2124
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia

Intervention

Device:
• LRT55 Testing
Testing on the Unyvero LRT55

Locations

Country	Name	City	State
United States	Summa Health System	Akron	Ohio
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of California Los Angeles (UCLA)	Los Angeles	California
United States	Columbia Universiy Medical Center / New York-Presbyterian Hosp.	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Rochester Medical Center	Rochester	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Curetis GmbH	Global BioClinical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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