Detection of Pneumonia associated Pathogens and Antibiotic Resistance Genes using the Curetis Unyvero® Pneumonia Applicatio

• Conditions: pneumoniahospital-acquired pneumonia; J13; J14; J15; J16; J17; Pneumonia due to Streptococcus pneumoniae; Pneumonia due to Haemophilus influenzae; Bacterial pneumonia, not elsewhere classified; Pneumonia due to other infectious organisms, not elsewhere classified

• Registration Number: DRKS00005684
• Lead Sponsor: Curetis AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2012-09-30
• Study Start: 2014-01-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 739

Inclusion Criteria

• Hospitalized subjects with suspicion of lower respiratory tract infection.
• Age at least 18 years.
• Any of the following sample types: sputum, respiratory aspirate, bronchial
lavage, combi cath®, and protected brushand bronchial lavage taken for
standard-of-care.
• Left-over sample amount = 1 ml (in addition to the volume required for
standard procedures).
• If required by national or institutional regulations, signed written informed
consent to participate in this clinical trial, with the exception for unconscious patients. For these patients the written informed consent has to be obtained as soon as subjects are conscious or from a person authorized to give informed consent for this subject.

Exclusion Criteria

Sample is not accepted for analysis by standard-of-care.
• Samples for which Curetis test cannot be performed at the same day of
start of microbiology testing.
• Known infection with tuberculosis
• Out-patient or ambulant patient.
• Previous analysis of a respiratory sample with the Unyvero Application
from the same patient within the past 5 days.
• Patient known to have been enrolled in another clinical study within the
last 6 months.
• Other sample types, like nasal swab or brush, bronchial swab or brush,
blood, throat washing, drainage, gastric juice, pleural punctuates.
• After arrival in the laboratory, sample storage time has exceeded up to
18 hours in the lab refrigerator, including up to 2 hours at room temperature (18 hours in total).

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of sensitivities of pathogen detection by the investigational test for each pathogen listed in the test panel.

Secondary Outcome Measures

Name	Time	Method
1. Evaluation of specificity of pathogen detection by the investigational test for each pathogen listed in the test panel.<br>2. Evaluation of correlation between results of genotypic resistance detection by the investigational test and phenotypic resistance detection by standard-of-care.<br>3. Comparison of time to result” of each pathogen and resistance gene detected by the investigational diagnostic test with standard procedures.<br>4. Evaluation of discrepant results of the investigational diagnostic procedure, following discrepant result resolution concerning pathogen detection.