SCAHAVAP: The Impact of Simultaneous Presence of Viral and Bacterial Pathogens on Therapy and Course of Severe Pneumonia
Study Details
Study Description
Brief Summary
The purpose of the study is to determine if the clinical course of pneumonia is more severe when both, bacterial and viral pathogens are find as possible causative agent and how does it affect treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Basic demographic data of the patients (age, gender), data on concomitant diseases and epidemiological circumstances will be collected
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.:
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blood count analysis
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differential blood count
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C- reactive protein, procalcitonin
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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
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arterial blood gas analysis
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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:
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cultivation of 2 pairs of blood cultures in all patients
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cultivation of sputum or quantitative cultivation of tracheal aspirate in nonintubated patients
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quantitative cultivation of tracheal aspirate or bronchoalveolar lavage in intubated patients
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testing the presence of soluble Legionella antigen in urine in all patients
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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
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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
Study Design
Outcome Measures
Primary Outcome Measures
- Rate of changes in empirical antibiotic therapy due to broad microbiological diagnostic [each patient will be assessed at enrollment and follow-up for 2 months]
Eligibility Criteria
Criteria
Inclusion Criteria: diagnosis of
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severe community acquired pneumonia or
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severe hospital acquired pneumonia or
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ventilator--associated pneumonia
Exclusion Criteria:
- antibiotic treatment of actual episode of pneumonia for more than 24 hours
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Intensive Care Unit. Department of Infectious Diseases, Umiversity Medical Centre Ljubljana, Japljeva 2 | Ljubljana | Slovenia | 1000 |
Sponsors and Collaborators
- University Medical Centre Ljubljana
- University of Ljubljana, Faculty of Medicine
Investigators
- Principal Investigator: Primoz Karner, Intensive Care Unit, Department of Infectious Diseases, University Medical Centre Ljubljana, Japljeva ulica 2, SI-1000 Ljubljana, Slovenia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Severe pneumonia