The Impact of Simultaneous Presence of Viral and Bacterial Pathogens on Therapy and Course of Severe Pneumonia
NCT ID: NCT02203110
Last Updated: 2014-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2014-01-31
2016-03-31
Brief Summary
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Detailed Description
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Severity of illness will be assessed by APACHE II (at day 1) and SOFA (at day 1,2,3 and 7) scoring system
Following laboratory tests will be performed at day 1, 2,3 and 7.:
* blood count analysis
* differential blood count
* C- reactive protein, procalcitonin
* glucose, urea, potassium, sodium, chloride, magnesium, creatinine, bilirubin, protein, albumin, alkaline phosphatase, aspartate aminotransferase, alanine transaminase, gamma-glutamyl transpeptidase , alpha-amylase, lipase, creatine kinase, lactate dehydrogenase, myoglobin
* arterial blood gas analysis
* tests of hemostasis.
Additional 2 mL of blood will be taken at day 1 and day 21 (or later), due to paired serologic testing
To establish the presence of potential pathogens we will perform following microbiological investigations:
* cultivation of 2 pairs of blood cultures in all patients
* cultivation of sputum or quantitative cultivation of tracheal aspirate in nonintubated patients
* quantitative cultivation of tracheal aspirate or bronchoalveolar lavage in intubated patients
* testing the presence of soluble Legionella antigen in urine in all patients
* testing the presence of genetic material of respiratory viruses (influenza A, influenza B, respiratory syncytial virus , adenovirus, bocavirus, coronavirus, metapneumovirus, parainfluenza virus, rhinovirus) by qualitative polymerase chain reaction (PCR) in nasopharyngeal swabs in all patients, in the tracheal aspirate in nonintubated patients and in tracheal aspirate or bronchoalveolar lavage fluid in intubated patients
* testing the presence of mycoplasmal, legionella and chlamydial DNA by qualitative PCR in nasopharyngeal smears in all patients, in the tracheal aspirate in nonintubated patients and in bronchoalveolar lavage fluid or in tracheal aspirate in intubated patients
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* severe hospital acquired pneumonia or
* ventilator--associated pneumonia
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Ljubljana, Faculty of Medicine
OTHER
University Medical Centre Ljubljana
OTHER
Responsible Party
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Primoz Karner
MD
Principal Investigators
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Primoz Karner
Role: PRINCIPAL_INVESTIGATOR
Intensive Care Unit, Department of Infectious Diseases, University Medical Centre Ljubljana, Japljeva ulica 2, SI-1000 Ljubljana, Slovenia
Locations
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Intensive Care Unit. Department of Infectious Diseases, Umiversity Medical Centre Ljubljana, Japljeva 2
Ljubljana, , Slovenia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Severe pneumonia
Identifier Type: -
Identifier Source: org_study_id
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