Detection of Microorganisms and Antibiotic Resistance Genes Using the Curetis Unyvero LRT55 Application
Public ClinicalTrials.gov record NCT01922024. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Detection of Microorganisms and Antibiotic Resistance Genes in Lower Respiratory Tract (LRT) Samples Using the Curetis Unyvero LRT55 Application
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01922024
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 2,124 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2015
- Primary completion
- Oct 31, 2016
- Completion
- Oct 31, 2016
- Last update posted
- Mar 4, 2019
2015 – 2016
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California Los Angeles (UCLA) | Los Angeles | California | 90049 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| Mayo Clinic | Rochester | Minnesota | 55901 | — |
| Columbia Universiy Medical Center / New York-Presbyterian Hosp. | New York | New York | 10032 | — |
| Rochester Medical Center | Rochester | New York | 14642 | — |
| Summa Health System | Akron | Ohio | 44304 | — |
| University of Washington | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01922024, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 4, 2019 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01922024 live on ClinicalTrials.gov.