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

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ClinicalTrials.gov Identifier: NCT02203110
Recruitment Status : Unknown
Verified July 2014 by Primoz Karner, University Medical Centre Ljubljana.
Recruitment status was:  Recruiting
First Posted : July 29, 2014
Last Update Posted : July 29, 2014
Sponsor:
Collaborator:
University of Ljubljana, Faculty of Medicine
Information provided by (Responsible Party):
Primoz Karner, University Medical Centre Ljubljana

Tracking Information
First Submitted Date July 25, 2014
First Posted Date July 29, 2014
Last Update Posted Date July 29, 2014
Study Start Date January 2014
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 25, 2014)
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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Impact of Simultaneous Presence of Viral and Bacterial Pathogens on Therapy and Course of Severe Pneumonia
Official Title The Impact of Simultaneous Presence of Viral and Bacterial Pathogens on Therapy and Course of Severe Pneumonia
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Whole blood, two 7 ml samples
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.
Condition
  • Community Acquired Pneumonia
  • Hospital Acquired Pneumonia
  • Ventilator Associated Pneumonia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 25, 2014)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2016
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number NCT02203110
Other Study ID Numbers Severe pneumonia
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Primoz Karner, University Medical Centre Ljubljana
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
PRS Account University Medical Centre Ljubljana
Verification Date July 2014