xml: <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/NCT05972980</url>
    </required_header>
    <id_info>
      <org_study_id>MR-VAP-C19</org_study_id>
      <nct_id>NCT05972980</nct_id>
    </id_info>
    <brief_title>Ventilator-Associated Pneumonia in Critically Ill COVID-19 vs. Non-COVID-19 Patients</brief_title>
    <official_title>Ventilator-Associated Pneumonia and Multidrug-Resistant Pathogens: A Prospective Observational Monocentric Comparative Study Between Critically Ill Non-COVID-19 and COVID-19 Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Turin, Italy</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Turin, Italy</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The COVID-19 pandemic has led to an increased incidence of ventilator-associated pneumonia&#xD;
        (VAP) among critically ill patients. However, in a context of high prevalence of&#xD;
        multidrug-resistant organisms (MDROs) there is a lack of direct comparison between the&#xD;
        incidence of VAP in COVID-19 and non-COVID-19 cohorts.&#xD;
  &#xD;
        The investigators conducted a prospective, single-center cohort study comparing COVID-19&#xD;
        patients admitted to the intensive care unit (ICU) of the Città della Salute e della Scienza&#xD;
        University Hospital in Turin, Italy, between March 2020 and December 2021 (COVID-19 group),&#xD;
        with a historical cohort of ICU-mixed patients admitted between June 2016 and March 2018&#xD;
        (NON-COVID-19 group).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study aims to explore the occurrence and characteristics of ventilator-associated&#xD;
        pneumonia (VAP) in critically ill patients during two distinct periods: the pre-pandemic era&#xD;
        and the COVID-19 pandemic. VAP, a serious complication arising from invasive mechanical&#xD;
        ventilation (IMV) lasting at least 48 hours, had a crude incidence of 5% to 40% before the&#xD;
        COVID-19 pandemic, whereas COVID-19 patients experienced even higher rates, reaching 48-64%.&#xD;
  &#xD;
        The COVID-19 pandemic triggered an unprecedented rise in ICU admissions due to severe acute&#xD;
        respiratory syndrome caused by the SARS-CoV-2 virus, leading to a considerable number of&#xD;
        patients requiring IMV. Mechanical ventilation is a known risk factor for VAP, and COVID-19&#xD;
        exacerbates this risk due to factors like disease-induced immunoparalysis, prolonged&#xD;
        mechanical ventilation and sedation, and more frequent application of prone positioning.&#xD;
  &#xD;
        Despite the widespread need for prolonged mechanical ventilation in COVID-19 patients, few&#xD;
        studies have compared the impact of VAP between pre-pandemic and COVID-19 populations.&#xD;
        Additionally, limited research exists on the risk factors for VAP development in COVID-19&#xD;
        patients and the use of scoring systems like SAPS and SOFA as prognostic factors in this&#xD;
        specific context. Although the coVAPid study offered insights into VAP risk factors in&#xD;
        COVID-19 patients compared to those with influenza, it inadequately addressed the prevalence&#xD;
        of multidrug-resistant organisms (MDROs) in this population, particularly&#xD;
        carbapenem-resistant Acinetobacter baumannii (CR-Ab). Hence, this study aims to bridge this&#xD;
        knowledge gap by investigating VAP's impact in a setting characterized by a high incidence of&#xD;
        multidrug resistance.&#xD;
  &#xD;
        To achieve this, the study will take place at the Molinette Hospital of the &quot;Città della&#xD;
        Salute e della Scienza&quot; University Hospital in Turin, Italy, over a six-year period, spanning&#xD;
        from January 2016 to December 2022. This retrospective, observational, and monocentric study&#xD;
        will focus on two distinct cohorts: the pre-pandemic cohort (NON-COVID-19) and the COVID-19&#xD;
        cohort.&#xD;
  &#xD;
        Researchers will identify ventilator-associated pneumonia (VAP) episodes based on the current&#xD;
        definitions provided by the European Center for Disease Prevention and Control (ECDC).&#xD;
        Patients will be monitored until hospital discharge to assess outcomes, including ICU&#xD;
        mortality, overall mortality, duration of ICU stay, and duration of hospitalization.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2016</start_date>
    <completion_date type="Actual">December 31, 2022</completion_date>
    <primary_completion_date type="Actual">January 1, 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>Mortality</measure>
      <time_frame>28 days</time_frame>
      <description>Mortality within the first 28 days from ICU admission</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ICU mortality</measure>
      <time_frame>From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months</time_frame>
      <description>Mortality during intensive care unit stay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital mortality</measure>
      <time_frame>From date of enrollment until the date of hospital discharge, assessed up to 6 months</time_frame>
      <description>Mortality during hospital stay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mechanical ventilation days</measure>
      <time_frame>From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months</time_frame>
      <description>Days of mechanical ventilation length of stay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ventilator acquired pneumonia incidence</measure>
      <time_frame>From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months</time_frame>
      <description>Incidence of ventilator acquired pneumonia</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ventilator acquired pneumonia incidence</measure>
      <time_frame>28 days</time_frame>
      <description>Incidence of ventilator acquired pneumonia</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Multidrug-resistant micro-organisms incidence</measure>
      <time_frame>From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months</time_frame>
      <description>Incidence of Multidrug-resistant micro-organisms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difficult to treat pathogens incidence</measure>
      <time_frame>From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months</time_frame>
      <description>Incidence of difficult to treat pathogens</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital length of stay</measure>
      <time_frame>From date of enrollment until the date of hospital discharge, assessed up to 6 months</time_frame>
      <description>Duration of hospital length of stay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intensive care unit length of stay</measure>
      <time_frame>From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months</time_frame>
      <description>Duration of intensive care unit length of stay</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">200</enrollment>
    <condition>Infections</condition>
    <condition>Critical Illness</condition>
    <condition>Superinfection</condition>
    <condition>Organ Failure, Multiple</condition>
    <condition>Ventilator Associated Pneumonia</condition>
    <condition>Septic Shock</condition>
    <arm_group>
      <arm_group_label>Non-COVID-19 cohort</arm_group_label>
      <description>Patients with Ventilator Acquired Pneumonia without COVID-19.&#xD;
  The patients belonging to the NON-COVID cohort were admitted to three intensive care units at Molinette Hospital (Turin, Italy):&#xD;
  General Intensive Care Unit - admitting primarily medically critical patients and a smaller proportion of surgical patients, originating from the Hospital's Emergency Department or other Intensive Care Units in Piedmont. It serves as the regional referral center for Extracorporeal Membrane Oxygenation (ECMO).&#xD;
  Emergency Department - Intensive Care Unit (PSAR) - admitting both medical and surgical patients in urgent conditions.&#xD;
  Cardiac - Intensive Care Unit- admitting patients undergoing elective or emergency cardio-surgical interventions, and serving as a referral center for heart and lung transplants and the implantation of external ventricular assists.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>COVID-19 cohort</arm_group_label>
      <description>Patients with Ventilator Acquired Pneumonia with COVID-19. Confirmation of pneumonia was achieved by using the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) technique on a sample collected from the lower respiratory tract.&#xD;
  The COVID-19 cohort consists of patients admitted at the &quot;Città della Salute e della Scienza&quot; University Hospital (Turin, Italy) in two intensive care units at Molinette Hospital, dedicated to treating critically ill patients with COVID-19.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>COVID-19</intervention_name>
      <description>The investigators stratified our population based on COVID-19 virus positivity to identify any risk factors in this population compared to the NON-COVID-19 population.</description>
      <arm_group_label>COVID-19 cohort</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population consists of patients diagnosed with ventilator-acquired pneumonia&#xD;
          admitted to the intensive care unit of the primary hospital &quot;Molinette,&quot; Città della Salute&#xD;
          e della Scienza, Turin, Italy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All adult patients diagnosed with ventilator-associated pneumonia&#xD;
  &#xD;
            -  Patients admitted to the intensive care units&#xD;
  &#xD;
            -  Patients who underwent mechanical ventilation for a duration longer than 48 hours&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients in extreme end-of-life conditions&#xD;
  &#xD;
            -  Pregnant individuals&#xD;
  &#xD;
            -  Patients under 18 years of age&#xD;
  &#xD;
            -  Patients who did not meet the diagnosis criteria for ventilator-associated pneumonia&#xD;
  &#xD;
            -  Patients who underwent mechanical ventilation for a duration equal to or shorter than&#xD;
               48 hours&#xD;
  &#xD;
            -  Ventilator-associated tracheobronchitis&#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>Luca Brazzi</last_name>
      <role>Study Chair</role>
      <affiliation>University of Torino</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>AOU Città della Salute e della Scienza di Torino</name>
        <address>
          <city>Torino</city>
          <zip>10100</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>Superinfection</mesh_term>
      <mesh_term>Critical Illness</mesh_term>
      <mesh_term>Multiple Organ Failure</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05972980
  org study id: MR-VAP-C19
  nct id: NCT05972980
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The COVID-19 pandemic has led to an increased incidence of ventilator-associated pneumonia
        (VAP) among critically ill patients. However, in a context of high prevalence of
        multidrug-resistant organisms (MDROs) there is a lack of direct comparison between the
        incidence of VAP in COVID-19 and non-COVID-19 cohorts.
  
        The investigators conducted a prospective, single-center cohort study comparing COVID-19
        patients admitted to the intensive care unit (ICU) of the Città della Salute e della Scienza
        University Hospital in Turin, Italy, between March 2020 and December 2021 (COVID-19 group),
        with a historical cohort of ICU-mixed patients admitted between June 2016 and March 2018
        (NON-COVID-19 group).
  The study aims to explore the occurrence and characteristics of ventilator-associated
        pneumonia (VAP) in critically ill patients during two distinct periods: the pre-pandemic era
        and the COVID-19 pandemic. VAP, a serious complication arising from invasive mechanical
        ventilation (IMV) lasting at least 48 hours, had a crude incidence of 5% to 40% before the
        COVID-19 pandemic, whereas COVID-19 patients experienced even higher rates, reaching 48-64%.
  
        The COVID-19 pandemic triggered an unprecedented rise in ICU admissions due to severe acute
        respiratory syndrome caused by the SARS-CoV-2 virus, leading to a considerable number of
        patients requiring IMV. Mechanical ventilation is a known risk factor for VAP, and COVID-19
        exacerbates this risk due to factors like disease-induced immunoparalysis, prolonged
        mechanical ventilation and sedation, and more frequent application of prone positioning.
  
        Despite the widespread need for prolonged mechanical ventilation in COVID-19 patients, few
        studies have compared the impact of VAP between pre-pandemic and COVID-19 populations.
        Additionally, limited research exists on the risk factors for VAP development in COVID-19
        patients and the use of scoring systems like SAPS and SOFA as prognostic factors in this
        specific context. Although the coVAPid study offered insights into VAP risk factors in
        COVID-19 patients compared to those with influenza, it inadequately addressed the prevalence
        of multidrug-resistant organisms (MDROs) in this population, particularly
        carbapenem-resistant Acinetobacter baumannii (CR-Ab). Hence, this study aims to bridge this
        knowledge gap by investigating VAP's impact in a setting characterized by a high incidence of
        multidrug resistance.
  
        To achieve this, the study will take place at the Molinette Hospital of the "Città della
        Salute e della Scienza" University Hospital in Turin, Italy, over a six-year period, spanning
        from January 2016 to December 2022. This retrospective, observational, and monocentric study
        will focus on two distinct cohorts: the pre-pandemic cohort (NON-COVID-19) and the COVID-19
        cohort.
  
        Researchers will identify ventilator-associated pneumonia (VAP) episodes based on the current
        definitions provided by the European Center for Disease Prevention and Control (ECDC).
        Patients will be monitored until hospital discharge to assess outcomes, including ICU
        mortality, overall mortality, duration of ICU stay, and duration of hospitalization.
  observational model: Cohort
  time perspective: Prospective
  measure: Mortality
  time frame: 28 days
  description: Mortality within the first 28 days from ICU admission
  measure: ICU mortality
  time frame: From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
  description: Mortality during intensive care unit stay
  measure: Hospital mortality
  time frame: From date of enrollment until the date of hospital discharge, assessed up to 6 months
  description: Mortality during hospital stay
  measure: Mechanical ventilation days
  time frame: From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
  description: Days of mechanical ventilation length of stay
  measure: Ventilator acquired pneumonia incidence
  time frame: From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
  description: Incidence of ventilator acquired pneumonia
  measure: Ventilator acquired pneumonia incidence
  time frame: 28 days
  description: Incidence of ventilator acquired pneumonia
  measure: Multidrug-resistant micro-organisms incidence
  time frame: From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
  description: Incidence of Multidrug-resistant micro-organisms
  measure: Difficult to treat pathogens incidence
  time frame: From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
  description: Incidence of difficult to treat pathogens
  measure: Hospital length of stay
  time frame: From date of enrollment until the date of hospital discharge, assessed up to 6 months
  description: Duration of hospital length of stay
  measure: Intensive care unit length of stay
  time frame: From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
  description: Duration of intensive care unit length of stay
  arm group label: Non-COVID-19 cohort
  description: Patients with Ventilator Acquired Pneumonia without COVID-19.
  The patients belonging to the NON-COVID cohort were admitted to three intensive care units at Molinette Hospital (Turin, Italy):
  General Intensive Care Unit - admitting primarily medically critical patients and a smaller proportion of surgical patients, originating from the Hospital's Emergency Department or other Intensive Care Units in Piedmont. It serves as the regional referral center for Extracorporeal Membrane Oxygenation (ECMO).
  Emergency Department - Intensive Care Unit (PSAR) - admitting both medical and surgical patients in urgent conditions.
  Cardiac - Intensive Care Unit- admitting patients undergoing elective or emergency cardio-surgical interventions, and serving as a referral center for heart and lung transplants and the implantation of external ventricular assists.
  arm group label: COVID-19 cohort
  description: Patients with Ventilator Acquired Pneumonia with COVID-19. Confirmation of pneumonia was achieved by using the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) technique on a sample collected from the lower respiratory tract.
  The COVID-19 cohort consists of patients admitted at the "Città della Salute e della Scienza" University Hospital (Turin, Italy) in two intensive care units at Molinette Hospital, dedicated to treating critically ill patients with COVID-19.
  intervention type: Other
  intervention name: COVID-19
  description: The investigators stratified our population based on COVID-19 virus positivity to identify any risk factors in this population compared to the NON-COVID-19 population.
  arm group label: COVID-19 cohort
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Luca Brazzi
  role: Study Chair
  affiliation: University of Torino
  facility: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Pneumonia
  mesh term: Pneumonia, Ventilator-Associated
  mesh term: Superinfection
  mesh term: Critical Illness
  mesh term: Multiple Organ Failure