CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,124 enrolled
Drug / intervention
LRT55 Testingdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01922024
NCT01922024N/ACompleted
CompareCT.gov

Detection of Microorganisms and Antibiotic Resistance Genes in Lower Respiratory Tract (LRT) Samples Using the Curetis Unyvero LRT55 Application

Curetis GmbH·observational·Posted Aug 14, 2013·Updated Mar 5, 2019

In Brief

An observational study evaluating LRT55 Testing for Pneumonia. Completed, enrolled 2,124 participants across 9 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPneumonia
CountriesUnited States
CollaboratorsGlobal BioClinical

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 14, 2013
Enrollment StartJun 1, 2015
Primary CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.9 years ago

Interventions

LRT55 Testingdevice

Testing on the Unyvero LRT55