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

NCT01922024 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2124

Last updated 2019-03-05

Study results available
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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.

Conditions

Interventions

DEVICE

LRT55 Testing

Testing on the Unyvero LRT55

Sponsors & Collaborators

  • Global BioClinical

    collaborator INDUSTRY

  • Curetis GmbH

    lead INDUSTRY

Principal Investigators

  • Johannes Bacher · Curetis GmbH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01922024 on ClinicalTrials.gov