<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/NCT03039998</url>
  </required_header>
  <id_info>
    <org_study_id>NT14382</org_study_id>
    <nct_id>NCT03039998</nct_id>
  </id_info>
  <brief_title>Validity of Biological Material Sampling in Patients With Hospital-acquired Pneumonia</brief_title>
  <official_title>Validity of Biological Material Sampling in Patients With Hospital-acquired Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Olomouc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Palacky University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Olomouc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of project is to compare validity of sampling methods performed routinely&#xD;
      (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological&#xD;
      agent responsible for hospital-acquired pneumonia (HAP) in critically ill patients to&#xD;
      bronchoscopy-assisted protected brush method. Evaluation of the present clinical praxis using&#xD;
      bronchial secretion sampling in HAP diagnostics and detection of the most common etiological&#xD;
      agents in patients with HAP are other priorities of the project. Aiming to confirm or exclude&#xD;
      the diagnosis of HAP, determine the sources and possible routes of bacterial pathogens&#xD;
      transmission molecular biology analysis of etiological agents is performed. Finally,&#xD;
      percentage of HAP etiological agents resistant to initial empiric antibiotic therapy will be&#xD;
      observed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of project will be comparing validity of sampling methods performed&#xD;
      routinely (bronchial secretion, stomach content, oropharyngeal smear) for determination of&#xD;
      etiological agent responsible for hospital-acquired pneumonia (HAP) in critically ill&#xD;
      patients to bronchoscopy-assisted protected brush method. Obtained results of different&#xD;
      methods will enable to determine if the bronchial secretion sample, stomach content sample or&#xD;
      oropharyngeal smear are comparable to precise but technically difficult protected brush.&#xD;
      Evaluation of the present clinical praxis using bronchial secretion sampling in HAP&#xD;
      diagnostics and detection of the most common etiological agents in patients with HAP will be&#xD;
      other priorities of the project. The role of atypical and fungal pathogens in HAP initiation&#xD;
      will be discovered as well. Aiming to confirm or exclude the diagnosis of HAP, determine the&#xD;
      sources and possible routes of bacterial pathogens transmission molecular biology analysis of&#xD;
      etiological agents will be performed. Finally, percentage of HAP etiological agents resistant&#xD;
      to initial empiric antibiotic therapy will be observed.&#xD;
&#xD;
      Project fulfills program objectives of molecular-biologic approaches and research support in&#xD;
      infectious diseases domain. It will make contribution to faster and more precise HAP&#xD;
      diagnosis and adequate antibiotic therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Sensitivity and specificity of diagnostic methods etiological agents HAP. Scale: sensitivity and specificity of each method.</measure>
    <time_frame>72 hours</time_frame>
    <description>Obtaining 4 types of agent samples: endotracheal aspirate, gastric aspirate, oropharyngeal swab and protected specimen brushing when clinical signs of HAP arisen and after 72 hours</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">56</enrollment>
  <condition>Hospital Acquired Pneumonia</condition>
  <arm_group>
    <arm_group_label>HAP Patients</arm_group_label>
    <description>HAP, intubated and mechanically ventilated.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      endotracheal aspirate, gastric aspirate, oropharyngeal swab, protected specimen brushing&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The patients hospitalized in the Department of Anesthesiology and Intensive Care Medicine,&#xD;
        Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital&#xD;
        Olomouc fulfilling HAP criteria will be enrolled in the study: presence of newly developed&#xD;
        or progressive infiltrates on chest radiographs after minimum of 48hours of hospitalization&#xD;
        plus at least two other signs of respiratory tract infection: temperature &gt;38 °C, purulent&#xD;
        sputum, leukocytosis &gt;10x103/mm3 or leukopenia &lt;4x103/mm3, signs of inflammation on&#xD;
        auscultation, cough and/or respiratory insufficiency with oxygenation index (Horowitz)&#xD;
        PaO2/ FiO2 ≤300 mm Hg. Clinically ongoing lung inflammation is verified by chest radiograph&#xD;
        or CT in the mechanically ventilated patient.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical signs of HAP&#xD;
&#xD;
          -  need for intubation and mechanical ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to obtain samples in 24 hours after clinical diagnosis of HAP&#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>Tomáš Gabrhelík, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Olomouc</affiliation>
  </overall_official>
  <reference>
    <citation>Vincent JL, Bihari DJ, Suter PM, Bruining HA, White J, Nicolas-Chanoin MH, Wolff M, Spencer RC, Hemmer M. The prevalence of nosocomial infection in intensive care units in Europe. Results of the European Prevalence of Infection in Intensive Care (EPIC) Study. EPIC International Advisory Committee. JAMA. 1995 Aug 23-30;274(8):639-44.</citation>
    <PMID>7637145</PMID>
  </reference>
  <reference>
    <citation>Uvizl R, Hanulik V, Husickova V, Sedlakova MH, Adamus M, Kolar M. Hospital-acquired pneumonia in ICU patients. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2011 Dec;155(4):373-8. doi: 10.5507/bp.2011.067.</citation>
    <PMID>22336651</PMID>
  </reference>
  <reference>
    <citation>American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.</citation>
    <PMID>15699079</PMID>
  </reference>
  <reference>
    <citation>Craven DE, Palladino R, McQuillen DP. Healthcare-associated pneumonia in adults: management principles to improve outcomes. Infect Dis Clin North Am. 2004 Dec;18(4):939-62. doi: 10.1016/j.idc.2004.08.001.</citation>
    <PMID>15555833</PMID>
  </reference>
  <reference>
    <citation>Uvizl R, Adamus M, Cerny V, Dusek L, Jarkovsky J, Sramek V, Matejovic M, Stourac P, Kula R, Malaska J, Sevcik P. Patient survival, predictive factors and disease course of severe sepsis in Czech intensive care units: A multicentre, retrospective, observational study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2016 Jun;160(2):287-97. doi: 10.5507/bp.2015.052. Epub 2015 Oct 23.</citation>
    <PMID>26526190</PMID>
  </reference>
  <reference>
    <citation>Jones RN. Microbial etiologies of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Clin Infect Dis. 2010 Aug 1;51 Suppl 1:S81-7. doi: 10.1086/653053. Erratum In: Clin Infect Dis. 2010 Nov 1;51(9):1114.</citation>
    <PMID>20597676</PMID>
  </reference>
  <reference>
    <citation>[Pneumonia-causing bacterial pathogens in intensive care patients]. Klin Mikrobiol Infekc Lek. 2011 Aug;17(4):135-40. Czech.</citation>
    <PMID>22052100</PMID>
  </reference>
  <reference>
    <citation>Torres A, Ewig S, Lode H, Carlet J; European HAP working group. Defining, treating and preventing hospital acquired pneumonia: European perspective. Intensive Care Med. 2009 Jan;35(1):9-29. doi: 10.1007/s00134-008-1336-9. Epub 2008 Nov 7.</citation>
    <PMID>18989656</PMID>
  </reference>
  <reference>
    <citation>Kowalczyk W, Rybicki Z, Tomaszewski D, Truszczynski A, Guzek A. [The comparison of different bronchial aspirate culturing methods in patients with ventilator-associated pneumonia (VAP)]. Anestezjol Intens Ter. 2011 Apr-Jun;43(2):74-9. Polish.</citation>
    <PMID>22011866</PMID>
  </reference>
  <reference>
    <citation>Butler KL, Best IM, Oster RA, Katon-Benitez I, Lynn Weaver W, Bumpers HL. Is bilateral protected specimen brush sampling necessary for the accurate diagnosis of ventilator-associated pneumonia? J Trauma. 2004 Aug;57(2):316-22. doi: 10.1097/01.ta.0000088858.22080.cb.</citation>
    <PMID>15345979</PMID>
  </reference>
  <reference>
    <citation>Gerbeaux P, Ledoray V, Boussuges A, Molenat F, Jean P, Sainty JM. Diagnosis of nosocomial pneumonia in mechanically ventilated patients: repeatability of the bronchoalveolar lavage. Am J Respir Crit Care Med. 1998 Jan;157(1):76-80. doi: 10.1164/ajrccm.157.1.9604070.</citation>
    <PMID>9445281</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>May 10, 2016</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Olomouc</investigator_affiliation>
    <investigator_full_name>Radovan Uvizl</investigator_full_name>
    <investigator_title>Radovan Uvízl, MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Healthcare-Associated Pneumonia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03039998
org study id: NT14382
nct id: NCT03039998
lead sponsor: 
collaborator: 
has dmc: No
The main objective of project is to compare validity of sampling methods performed routinely
      (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological
      agent responsible for hospital-acquired pneumonia (HAP) in critically ill patients to
      bronchoscopy-assisted protected brush method. Evaluation of the present clinical praxis using
      bronchial secretion sampling in HAP diagnostics and detection of the most common etiological
      agents in patients with HAP are other priorities of the project. Aiming to confirm or exclude
      the diagnosis of HAP, determine the sources and possible routes of bacterial pathogens
      transmission molecular biology analysis of etiological agents is performed. Finally,
      percentage of HAP etiological agents resistant to initial empiric antibiotic therapy will be
      observed.
The main objective of project will be comparing validity of sampling methods performed
      routinely (bronchial secretion, stomach content, oropharyngeal smear) for determination of
      etiological agent responsible for hospital-acquired pneumonia (HAP) in critically ill
      patients to bronchoscopy-assisted protected brush method. Obtained results of different
      methods will enable to determine if the bronchial secretion sample, stomach content sample or
      oropharyngeal smear are comparable to precise but technically difficult protected brush.
      Evaluation of the present clinical praxis using bronchial secretion sampling in HAP
      diagnostics and detection of the most common etiological agents in patients with HAP will be
      other priorities of the project. The role of atypical and fungal pathogens in HAP initiation
      will be discovered as well. Aiming to confirm or exclude the diagnosis of HAP, determine the
      sources and possible routes of bacterial pathogens transmission molecular biology analysis of
      etiological agents will be performed. Finally, percentage of HAP etiological agents resistant
      to initial empiric antibiotic therapy will be observed.

      Project fulfills program objectives of molecular-biologic approaches and research support in
      infectious diseases domain. It will make contribution to faster and more precise HAP
      diagnosis and adequate antibiotic therapy.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity and specificity of diagnostic methods etiological agents HAP. Scale: sensitivity and specificity of each method.
time frame: 72 hours
description: Obtaining 4 types of agent samples: endotracheal aspirate, gastric aspirate, oropharyngeal swab and protected specimen brushing when clinical signs of HAP arisen and after 72 hours
arm group label: HAP Patients
description: HAP, intubated and mechanically ventilated.
endotracheal aspirate, gastric aspirate, oropharyngeal swab, protected specimen brushing
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tomáš Gabrhelík, MD, PhD
role: Principal Investigator
affiliation: University Hospital Olomouc
citation: Vincent JL, Bihari DJ, Suter PM, Bruining HA, White J, Nicolas-Chanoin MH, Wolff M, Spencer RC, Hemmer M. The prevalence of nosocomial infection in intensive care units in Europe. Results of the European Prevalence of Infection in Intensive Care (EPIC) Study. EPIC International Advisory Committee. JAMA. 1995 Aug 23-30;274(8):639-44.
PMID: 7637145
citation: Uvizl R, Hanulik V, Husickova V, Sedlakova MH, Adamus M, Kolar M. Hospital-acquired pneumonia in ICU patients. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2011 Dec;155(4):373-8. doi: 10.5507/bp.2011.067.
PMID: 22336651
citation: American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
PMID: 15699079
citation: Craven DE, Palladino R, McQuillen DP. Healthcare-associated pneumonia in adults: management principles to improve outcomes. Infect Dis Clin North Am. 2004 Dec;18(4):939-62. doi: 10.1016/j.idc.2004.08.001.
PMID: 15555833
citation: Uvizl R, Adamus M, Cerny V, Dusek L, Jarkovsky J, Sramek V, Matejovic M, Stourac P, Kula R, Malaska J, Sevcik P. Patient survival, predictive factors and disease course of severe sepsis in Czech intensive care units: A multicentre, retrospective, observational study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2016 Jun;160(2):287-97. doi: 10.5507/bp.2015.052. Epub 2015 Oct 23.
PMID: 26526190
citation: Jones RN. Microbial etiologies of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Clin Infect Dis. 2010 Aug 1;51 Suppl 1:S81-7. doi: 10.1086/653053. Erratum In: Clin Infect Dis. 2010 Nov 1;51(9):1114.
PMID: 20597676
citation: [Pneumonia-causing bacterial pathogens in intensive care patients]. Klin Mikrobiol Infekc Lek. 2011 Aug;17(4):135-40. Czech.
PMID: 22052100
citation: Torres A, Ewig S, Lode H, Carlet J; European HAP working group. Defining, treating and preventing hospital acquired pneumonia: European perspective. Intensive Care Med. 2009 Jan;35(1):9-29. doi: 10.1007/s00134-008-1336-9. Epub 2008 Nov 7.
PMID: 18989656
citation: Kowalczyk W, Rybicki Z, Tomaszewski D, Truszczynski A, Guzek A. [The comparison of different bronchial aspirate culturing methods in patients with ventilator-associated pneumonia (VAP)]. Anestezjol Intens Ter. 2011 Apr-Jun;43(2):74-9. Polish.
PMID: 22011866
citation: Butler KL, Best IM, Oster RA, Katon-Benitez I, Lynn Weaver W, Bumpers HL. Is bilateral protected specimen brush sampling necessary for the accurate diagnosis of ventilator-associated pneumonia? J Trauma. 2004 Aug;57(2):316-22. doi: 10.1097/01.ta.0000088858.22080.cb.
PMID: 15345979
citation: Gerbeaux P, Ledoray V, Boussuges A, Molenat F, Jean P, Sainty JM. Diagnosis of nosocomial pneumonia in mechanically ventilated patients: repeatability of the bronchoalveolar lavage. Am J Respir Crit Care Med. 1998 Jan;157(1):76-80. doi: 10.1164/ajrccm.157.1.9604070.
PMID: 9445281
responsible party type: Principal Investigator
investigator affiliation: University Hospital Olomouc
investigator full name: Radovan Uvizl
investigator title: Radovan Uvízl, MD, PhD
mesh term: Pneumonia
mesh term: Healthcare-Associated Pneumonia
sharing ipd: No