N/A
N=2,124
Detection of Microorganisms and Antibiotic Resistance Genes Using the Curetis Unyvero LRT55 Application
Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT01922024 ↗Enrolled (actual)
2,124
Serious AEs
—
Results posted
Mar 2019
Primary outcome: Primary: Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing — 91.4; 91.4; 99.5; 99.5 Percentage
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- LRT55 Testing (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Curetis GmbH
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing |
91.4; 91.4; 99.5; 99.5; 89.9; 89.9 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01922024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.