DRKS00005684
Completed
Not Applicable
Detection of Pneumonia associated Pathogens and Antibiotic Resistance Genes using the Curetis Unyvero® Pneumonia Application - CS-2011
Curetis AG0 sites739 target enrollmentJanuary 28, 2014
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- pneumoniahospital-acquired pneumonia
- Sponsor
- Curetis AG
- Enrollment
- 739
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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,
Outcomes
Primary Outcomes
Not specified
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