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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Community Acquired Pneumonia Hospital Acquired Pneumonia Ventilator Associated Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* severe community acquired pneumonia or
* severe hospital acquired pneumonia or
* ventilator--associated pneumonia

Exclusion Criteria

* antibiotic treatment of actual episode of pneumonia for more than 24 hours
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ljubljana, Faculty of Medicine

OTHER

Sponsor Role collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Primoz Karner

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Primoz Karner

Role: CONTACT

+386 51 345616

Matjaz Jereb

Role: CONTACT

+386 1 522 8170

Facility Contacts

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Primoz Karner

Role: primary

+386 51 345616

Matjaz Jereb

Role: backup

+386 1 522 8170

Other Identifiers

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Severe pneumonia

Identifier Type: -

Identifier Source: org_study_id

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