Detection of Microorganisms and Antibiotic Resistance Genes Using the Curetis Unyvero LRT55 Application
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing [Up to 12 months]
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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California Los Angeles (UCLA) | Los Angeles | California | United States | 90049 |
| 2 | Northwestern Memorial Hospital | Chicago | Illinois | United States | 60611 |
| 3 | Johns Hopkins Hospital | Baltimore | Maryland | United States | 21287 |
| 4 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073 |
| 5 | Mayo Clinic | Rochester | Minnesota | United States | 55901 |
| 6 | Columbia Universiy Medical Center / New York-Presbyterian Hosp. | New York | New York | United States | 10032 |
| 7 | Rochester Medical Center | Rochester | New York | United States | 14642 |
| 8 | Summa Health System | Akron | Ohio | United States | 44304 |
| 9 | University of Washington | Seattle | Washington | United States | 98195 |
Sponsors and Collaborators
- Curetis GmbH
- Global BioClinical
Investigators
- Study Director: Johannes Bacher, Curetis GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CURETIS LRT55 Study - V 6.0
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Prospective Fresh Clinical Specimens | Retrospective Frozen Clinical Specimens |
|---|---|---|
| Arm/Group Description | 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 LRT55 Testing: Testing on the Unyvero LRT55 | Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against routine clinical microbiology LRT55 Testing: Testing on the Unyvero LRT55 |
| Period Title: Overall Study | ||
| STARTED | 1653 | 471 |
| COMPLETED | 1653 | 471 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Prospective Fresh Clinical Specimens | Retrospective Frozen Clinical Specimens | Total |
|---|---|---|---|
| Arm/Group Description | 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 LRT55 Testing: Testing on the Unyvero LRT55 | Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against routine clinical microbiology LRT55 Testing: Testing on the Unyvero LRT55 | Total of all reporting groups |
| Overall Participants | 1653 | 471 | 2124 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
827
50%
|
186
39.5%
|
1013
47.7%
|
| >=65 years |
826
50%
|
285
60.5%
|
1111
52.3%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
665
40.2%
|
182
38.6%
|
847
39.9%
|
| Male |
988
59.8%
|
289
61.4%
|
1277
60.1%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
1653
100%
|
471
100%
|
2124
100%
|
Outcome Measures
| Title | Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing |
|---|---|
| Description | 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. |
| Time Frame | Up to 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Prospective Fresh Clinical Specimens | Retrospective Frozen Clinical Specimens |
|---|---|---|
| Arm/Group Description | 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 LRT55 Testing: Testing on the Unyvero LRT55 an overall weighted average sensitivity of 91.4% for detection of panel pathogens an overall weighted average specificity of 99.5% for detection of panel pathogens an overall weighted average sensitivity of 89.9 % for detection of resistance markers an overall weighted average specificity of 99.3 % for detection of resistance markers | Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against routine clinical microbiology LRT55 Testing: Testing on the Unyvero LRT55 an overall weighted average sensitivity of 91.4% for detection of panel pathogens an overall weighted average specificity of 99.5% for detection of panel pathogens an overall weighted average sensitivity of 89.9 % for detection of resistance markers an overall weighted average specificity of 99.3 % for detection of resistance markers |
| Measure Participants | 1653 | 471 |
| Sensitivity - Pathogen Detection |
91.4
|
91.4
|
| Specificity- Pathogen Detection |
99.5
|
99.5
|
| Sensitivity - Restistance Marker Detection |
89.9
|
89.9
|
| Specificity - Resistance Marker Detection |
99.3
|
99.3
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | There were no adverse events monitored or occurring in this study, because this study utilized remnant human biospecimens that had previously been collected for clinical diagnosis not related to the study. All specimens and study testing results were de-identified and had not impact on patient care or treatment. | |||
| Arm/Group Title | Prospective Fresh Clinical Specimens | Retrospective Frozen Clinical Specimens | ||
| Arm/Group Description | 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 LRT55 Testing: Testing on the Unyvero LRT55 | Patients with suspicion of lower respiratory tract infection (pneumonia), samples tested with Unyvero LRT 55 cartridge and results compared against routine clinical microbiology LRT55 Testing: Testing on the Unyvero LRT55 | ||
All Cause Mortality |
||||
| Prospective Fresh Clinical Specimens | Retrospective Frozen Clinical Specimens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Prospective Fresh Clinical Specimens | Retrospective Frozen Clinical Specimens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
| Prospective Fresh Clinical Specimens | Retrospective Frozen Clinical Specimens | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Clinical Operations |
|---|---|
| Organization | Curetis USA, Inc. |
| Phone | 800-659-1221 |
| neil.mucci@curetis.com |
- CURETIS LRT55 Study - V 6.0