<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02203110</url>
  </required_header>
  <id_info>
    <org_study_id>Severe pneumonia</org_study_id>
    <nct_id>NCT02203110</nct_id>
  </id_info>
  <brief_title>The Impact of Simultaneous Presence of Viral and Bacterial Pathogens on Therapy and Course of Severe Pneumonia</brief_title>
  <acronym>SCAHAVAP</acronym>
  <official_title>The Impact of Simultaneous Presence of Viral and Bacterial Pathogens on Therapy and Course of Severe Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Centre Ljubljana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Ljubljana, Faculty of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Medical Centre Ljubljana</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine if the clinical course of pneumonia is more severe&#xD;
      when both, bacterial and viral pathogens are find as possible causative agent and how does it&#xD;
      affect treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Basic demographic data of the patients (age, gender), data on concomitant diseases and&#xD;
      epidemiological circumstances will be collected&#xD;
&#xD;
      Severity of illness will be assessed by APACHE II (at day 1) and SOFA (at day 1,2,3 and 7)&#xD;
      scoring system&#xD;
&#xD;
      Following laboratory tests will be performed at day 1, 2,3 and 7.:&#xD;
&#xD;
        -  blood count analysis&#xD;
&#xD;
        -  differential blood count&#xD;
&#xD;
        -  C- reactive protein, procalcitonin&#xD;
&#xD;
        -  glucose, urea, potassium, sodium, chloride, magnesium, creatinine, bilirubin, protein,&#xD;
           albumin, alkaline phosphatase, aspartate aminotransferase, alanine transaminase,&#xD;
           gamma-glutamyl transpeptidase , alpha-amylase, lipase, creatine kinase, lactate&#xD;
           dehydrogenase, myoglobin&#xD;
&#xD;
        -  arterial blood gas analysis&#xD;
&#xD;
        -  tests of hemostasis.&#xD;
&#xD;
      Additional 2 mL of blood will be taken at day 1 and day 21 (or later), due to paired&#xD;
      serologic testing&#xD;
&#xD;
      To establish the presence of potential pathogens we will perform following microbiological&#xD;
      investigations:&#xD;
&#xD;
        -  cultivation of 2 pairs of blood cultures in all patients&#xD;
&#xD;
        -  cultivation of sputum or quantitative cultivation of tracheal aspirate in nonintubated&#xD;
           patients&#xD;
&#xD;
        -  quantitative cultivation of tracheal aspirate or bronchoalveolar lavage in intubated&#xD;
           patients&#xD;
&#xD;
        -  testing the presence of soluble Legionella antigen in urine in all patients&#xD;
&#xD;
        -  testing the presence of genetic material of respiratory viruses (influenza A, influenza&#xD;
           B, respiratory syncytial virus , adenovirus, bocavirus, coronavirus, metapneumovirus,&#xD;
           parainfluenza virus, rhinovirus) by qualitative polymerase chain reaction (PCR) in&#xD;
           nasopharyngeal swabs in all patients, in the tracheal aspirate in nonintubated patients&#xD;
           and in tracheal aspirate or bronchoalveolar lavage fluid in intubated patients&#xD;
&#xD;
        -  testing the presence of mycoplasmal, legionella and chlamydial DNA by qualitative PCR in&#xD;
           nasopharyngeal smears in all patients, in the tracheal aspirate in nonintubated patients&#xD;
           and in bronchoalveolar lavage fluid or in tracheal aspirate in intubated patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">March 2016</completion_date>
  <primary_completion_date type="Anticipated">March 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of changes in empirical antibiotic therapy due to broad microbiological diagnostic</measure>
    <time_frame>each patient will be assessed at enrollment and follow-up for 2 months</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Community Acquired Pneumonia</condition>
  <condition>Hospital Acquired Pneumonia</condition>
  <condition>Ventilator Associated Pneumonia</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood, two 7 ml samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients admited to Intensive Care Unit Department of Infectious Diseases University&#xD;
        Medical Centre Ljubljana due to severe pneumonia or pneumonia will develop during their&#xD;
        stay in ICU.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: diagnosis of&#xD;
&#xD;
          -  severe community acquired pneumonia or&#xD;
&#xD;
          -  severe hospital acquired pneumonia or&#xD;
&#xD;
          -  ventilator--associated pneumonia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  antibiotic treatment of actual episode of pneumonia for more than 24 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Primoz Karner</last_name>
    <role>Principal Investigator</role>
    <affiliation>Intensive Care Unit, Department of Infectious Diseases, University Medical Centre Ljubljana, Japljeva ulica 2, SI-1000 Ljubljana, Slovenia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Primoz Karner</last_name>
    <phone>+386 51 345616</phone>
    <email>primoz.karner@guest.arnes.si</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Matjaz Jereb</last_name>
    <phone>+386 1 522 8170</phone>
    <email>matjaz.jereb@kclj.si</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Intensive Care Unit. Department of Infectious Diseases, Umiversity Medical Centre Ljubljana, Japljeva 2</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primoz Karner</last_name>
      <phone>+386 51 345616</phone>
      <email>primoz.karner@guest.arnes.si</email>
    </contact>
    <contact_backup>
      <last_name>Matjaz Jereb</last_name>
      <phone>+386 1 522 8170</phone>
      <email>matjaz.jereb@kclj.si</email>
    </contact_backup>
    <investigator>
      <last_name>Primoz Karner</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 25, 2014</last_update_submitted>
  <last_update_submitted_qc>July 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Centre Ljubljana</investigator_affiliation>
    <investigator_full_name>Primoz Karner</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>simultaneous bacterial and viral pneumonia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pneumonia, Ventilator-Associated</mesh_term>
    <mesh_term>Healthcare-Associated Pneumonia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02203110
org study id: Severe pneumonia
nct id: NCT02203110
lead sponsor: 
collaborator: 
has dmc: No
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.
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
observational model: Cohort
time perspective: Prospective
measure: 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
Whole blood, two 7 ml samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Primoz Karner
role: Principal Investigator
affiliation: Intensive Care Unit, Department of Infectious Diseases, University Medical Centre Ljubljana, Japljeva ulica 2, SI-1000 Ljubljana, Slovenia
last name: Primoz Karner
phone: +386 51 345616
email: primoz.karner@guest.arnes.si
last name: Matjaz Jereb
phone: +386 1 522 8170
email: matjaz.jereb@kclj.si
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Slovenia
responsible party type: Principal Investigator
investigator affiliation: University Medical Centre Ljubljana
investigator full name: Primoz Karner
investigator title: MD
mesh term: Pneumonia
mesh term: Pneumonia, Ventilator-Associated
mesh term: Healthcare-Associated Pneumonia