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

July 25, 2014 updated by: Primoz Karner, University Medical Centre Ljubljana
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.

Study Overview

Status

Unknown

Conditions

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.:

  • 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

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Recruiting
        • Intensive Care Unit. Department of Infectious Diseases, Umiversity Medical Centre Ljubljana, Japljeva 2
        • Contact:
        • Contact:
        • Principal Investigator:
          • Primoz Karner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients admited to Intensive Care Unit Department of Infectious Diseases University Medical Centre Ljubljana due to severe pneumonia or pneumonia will develop during their stay in ICU.

Description

Inclusion Criteria: diagnosis of

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of changes in empirical antibiotic therapy due to broad microbiological diagnostic
Time Frame: each patient will be assessed at enrollment and follow-up for 2 months
each patient will be assessed at enrollment and follow-up for 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

July 25, 2014

First Submitted That Met QC Criteria

July 25, 2014

First Posted (Estimate)

July 29, 2014

Study Record Updates

Last Update Posted (Estimate)

July 29, 2014

Last Update Submitted That Met QC Criteria

July 25, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Severe pneumonia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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