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Trial record 74 of 257 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

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

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
Community Acquired Pneumonia Hospital Acquired Pneumonia Ventilator Associated Pneumonia

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

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Simultaneous Presence of Viral and Bacterial Pathogens on Therapy and Course of Severe Pneumonia
Study Start Date : January 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia




Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples Without DNA
Whole blood, two 7 ml samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203110


Contacts
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Contact: Primoz Karner +386 51 345616 primoz.karner@guest.arnes.si
Contact: Matjaz Jereb +386 1 522 8170 matjaz.jereb@kclj.si

Locations
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Slovenia
Intensive Care Unit. Department of Infectious Diseases, Umiversity Medical Centre Ljubljana, Japljeva 2 Recruiting
Ljubljana, Slovenia, 1000
Contact: Primoz Karner    +386 51 345616    primoz.karner@guest.arnes.si   
Contact: Matjaz Jereb    +386 1 522 8170    matjaz.jereb@kclj.si   
Principal Investigator: Primoz Karner         
Sponsors and Collaborators
University Medical Centre Ljubljana
University of Ljubljana, Faculty of Medicine
Investigators
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Principal Investigator: Primoz Karner Intensive Care Unit, Department of Infectious Diseases, University Medical Centre Ljubljana, Japljeva ulica 2, SI-1000 Ljubljana, Slovenia

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Responsible Party: Primoz Karner, MD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02203110     History of Changes
Other Study ID Numbers: Severe pneumonia
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014
Keywords provided by Primoz Karner, University Medical Centre Ljubljana:
simultaneous bacterial and viral pneumonia
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Healthcare-Associated Pneumonia
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes