Pneumonia
Conditions
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.
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.
Interventions
DEVICELRT55 Testing
Testing on the Unyvero LRT55
Sponsors
Global BioClinical
Curetis GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
LRT55 Testing: Testing on the Unyvero LRT55 | 1,653 |
| 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
LRT55 Testing: Testing on the Unyvero LRT55 | 471 |
| Total | 2,124 |
Baseline characteristics
| Characteristic | Prospective Fresh Clinical Specimens | Retrospective Frozen Clinical Specimens | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 826 Participants | 285 Participants | 1111 Participants |
| Age, Categorical Between 18 and 65 years | 827 Participants | 186 Participants | 1013 Participants |
| Region of Enrollment United States | 1653 participants | 471 participants | 2124 participants |
| Sex: Female, Male Female | 665 Participants | 182 Participants | 847 Participants |
| Sex: Female, Male Male | 988 Participants | 289 Participants | 1277 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Up to 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Prospective Fresh Clinical Specimens | Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing | Sensitivity - Pathogen Detection | 91.4 Percentage |
| Prospective Fresh Clinical Specimens | Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing | Specificity- Pathogen Detection | 99.5 Percentage |
| Prospective Fresh Clinical Specimens | Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing | Sensitivity - Restistance Marker Detection | 89.9 Percentage |
| Prospective Fresh Clinical Specimens | Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing | Specificity - Resistance Marker Detection | 99.3 Percentage |
| Retrospective Frozen Clinical Specimens | Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing | Specificity - Resistance Marker Detection | 99.3 Percentage |
| Retrospective Frozen Clinical Specimens | Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing | Sensitivity - Pathogen Detection | 91.4 Percentage |
| Retrospective Frozen Clinical Specimens | Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing | Sensitivity - Restistance Marker Detection | 89.9 Percentage |
| Retrospective Frozen Clinical Specimens | Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing | Specificity- Pathogen Detection | 99.5 Percentage |