pneumonia hospital-acquired pneumonia J13 J14 J15 J16 J17
Conditions
Interventions
Group 1: Hospitalized male and female individuals with suspicion of lower respiratory tract infection. The study shall include a minimum of N =2,000 subjects with up to 1,000 subjects in Europe and at
one aliquot will be used for standard diagnostic testing, one for investigational testing and the third aliquot will be stored for discrepant result resolution. The sampling is not trial-related and t
Sponsors
Curetis AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of sensitivities of pathogen detection by the investigational test for each pathogen listed in the test panel. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation of specificity of pathogen detection by the investigational test for each pathogen listed in the test panel. 2. Evaluation of correlation between results of genotypic resistance detection by the investigational test and phenotypic resistance detection by standard-of-care. 3. Comparison of “time to result” of each pathogen and resistance gene detected by the investigational diagnostic test with standard procedures. 4. Evaluation of discrepant results of the investigational diagnostic procedure, following discrepant result resolution concerning pathogen detection. | — |
Countries
Belgium, Germany, Spain
Contacts
Public ContactBerit Schulte
Universitätsklinikum TübingenInstitut für Medizinische Mikrobiologie und Hygiene
Outcome results
None listed