The Impact of Simultaneous Presence of Viral and Bacterial Pathogens on Therapy and Course of Severe Pneumonia (SCAHAVAP)

University Medical Centre Ljubljana

Status

Unknown

Conditions

Ventilator Associated Pneumonia

Hospital Acquired Pneumonia

Community Acquired Pneumonia

Study type

Observational

Funder types

Other

Identifiers

NCT02203110

Severe pneumonia

Details and patient eligibility

About

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.

Full 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.:

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

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: diagnosis of