<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/NCT04488510</url>
  </required_header>
  <id_info>
    <org_study_id>COVAP</org_study_id>
    <nct_id>NCT04488510</nct_id>
  </id_info>
  <brief_title>Pathogens Involved in Secondary Infections During Severe Forms of Covid-19 Pneumonia:</brief_title>
  <acronym>COVAP</acronym>
  <official_title>Pathogens Involved in Secondary Infections During Severe Forms of Covid-19 Pneumonia: COVAP Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier Victor Dupouy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</source>
  <brief_summary>
    <textblock>
      A Respiratory infection with the SARS-CoV2 virus is associated with a major risk of viral&#xD;
      pneumonia that can lead to respiratory distress requiring resuscitation. In the most severe&#xD;
      forms, it may require mechanical ventilation or even lead to an acute respiratory distress&#xD;
      syndrome with a particularly poor prognosis. The SARS-CoV2 is a single-stranded RNA virus of&#xD;
      positive polarity and belongs to the beta genus of Coronaviruses. SARS-CoV2 is responsible&#xD;
      for the third epidemic in less than twenty years secondary to a Coronavirus (SARS-CoV then&#xD;
      MERS-CoV) and if the mortality associated with it is lower than that of previous strains,&#xD;
      notably MERS-CoV, its spread is considerably big. As a result, the number of patients&#xD;
      developing respiratory distress requiring invasive mechanical ventilation is high, with&#xD;
      prolonged ventilation duration in these situations&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients requiring invasive mechanical ventilation are at risk of secondary, nosocomial, a&#xD;
      hospitalization in the ICU service and can affect up to 40% of ventilated patients. The&#xD;
      occurrence of ventilator-associated pneumonia is associated with an increase in the duration&#xD;
      of mechanical ventilation and its effect on mortality remains uncertain under general&#xD;
      conditions. The mechanisms underlying the occurrence of lower respiratory infection during&#xD;
      invasive mechanical ventilation are numerous, depending for the most part on two distinct&#xD;
      elements: the occurrence of transcolonisation, which will secondarily promote colonisation of&#xD;
      the lower respiratory tract, and the modification of the competence of the immune system in&#xD;
      its response to aggression by microbial agents whose pathogenicity is highly variable.&#xD;
&#xD;
      Throughout the infection by SARS-CoV2, the theoretical risk of secondary respiratory&#xD;
      infection during mechanical ventilation is important due to the intrication of three&#xD;
      concomitant phenomena: direct pulmonary aggression, which will alter the functionality of&#xD;
      local immunity, the &quot;cytokinic storm&quot;, responsible for the severity of the respiratory&#xD;
      picture that motivated intubation and the need for mechanical ventilation leading inevitably&#xD;
      to transcolonisation. Despite all of these pathophysiological arguments, very little data are&#xD;
      available on the possibility of secondary low respiratory tract infection occurring during&#xD;
      SARS-CoV2 infection and more generally during Coronarivus infections. even though all of&#xD;
      these elements are well known and widely studied, very little data are currently available on&#xD;
      the potential interaction between Coronaviruses and bacteria. The importance of this issue is&#xD;
      very significant as recent observations tend to show a relative rarity of the occurrence of&#xD;
      secondary lung infections during mechanical ventilation and the population of smokers,&#xD;
      subject to chronic obstructive bronchitis (usually particularly susceptible to bacterial&#xD;
      superinfections), does not appear to be more affected than that of non-smokers although the&#xD;
      current data are very partial.&#xD;
&#xD;
      The research is prospective, non interventional study that involves patients suffering from&#xD;
      another severe form a COVID-19 infection: the nosocomial pneumonia under mechanical&#xD;
      ventilation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 11, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2023</completion_date>
  <primary_completion_date type="Actual">September 10, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Research of the bacteria responsible for nosocomial pneumonia</measure>
    <time_frame>6 months</time_frame>
    <description>Establishing a biobank of the bacterial agents responsible for nosocomial pneumonia acquired under mechanical ventilation in order to: better understand the particularities of the bacteria responsible and obtain the &quot;clinical&quot; strains for in vitro studies that will be carried out secondarily.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Additional evaluations to the study</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluation of the adhesion properties to the bronchial epithelium (LPS peculiarities of Gram-negative bacteria, the interaction with the virus in in vitro models and the different molecules of interest in the collected bronchial secretions).</description>
  </secondary_outcome>
  <enrollment type="Actual">22</enrollment>
  <condition>Covid19</condition>
  <condition>Ventilator Associated Pneumonia</condition>
  <condition>Nosocomial Pneumonia</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      During the inclusion, a 4 ml citrate tube of blood in addition to the usual management&#xD;
      assessment and aspiration of tracheal secretions will be performed at D1, D3 and D7. Tracheal&#xD;
      aspiration is performed systematically in order to limit patient congestion and the risk of&#xD;
      atelectasis.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patient aged over 18 years, infected by the COVID-19 with a severe form of pneumonia&#xD;
        especially the nosocomial pneumonia acquired under mechanical ventilation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient whose age ≥ 18 years old&#xD;
&#xD;
          -  French-speaking patient&#xD;
&#xD;
          -  Patient whose COVID-19 infection was diagnosed by either a laboratory test, PCR or any&#xD;
             other commercial or public health test.&#xD;
&#xD;
          -  Adult acute respiratory distress syndrome according to the Berlin definition&#xD;
&#xD;
          -  Pneumonia acquired under mechanical ventilation defined according to the criteria of&#xD;
             international companies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient/family or proxy opposing participation in the study&#xD;
&#xD;
          -  Patient under guardianship or curatorship&#xD;
&#xD;
          -  Patient deprived of liberty&#xD;
&#xD;
          -  Patient under the safeguard of justice.&#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>François PHILLIPART, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation Hôpital Saint-Joseph</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint-Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pneumonia under mechanical ventilation</keyword>
  <keyword>ICU</keyword>
  <keyword>covid19</keyword>
  <keyword>coronavirus</keyword>
  <keyword>nosocomial pneumonia</keyword>
  <keyword>bacteria</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pneumonia, Ventilator-Associated</mesh_term>
    <mesh_term>Healthcare-Associated Pneumonia</mesh_term>
    <mesh_term>Coinfection</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/NCT04488510
org study id: COVAP
nct id: NCT04488510
lead sponsor: 
collaborator: 
A Respiratory infection with the SARS-CoV2 virus is associated with a major risk of viral
      pneumonia that can lead to respiratory distress requiring resuscitation. In the most severe
      forms, it may require mechanical ventilation or even lead to an acute respiratory distress
      syndrome with a particularly poor prognosis. The SARS-CoV2 is a single-stranded RNA virus of
      positive polarity and belongs to the beta genus of Coronaviruses. SARS-CoV2 is responsible
      for the third epidemic in less than twenty years secondary to a Coronavirus (SARS-CoV then
      MERS-CoV) and if the mortality associated with it is lower than that of previous strains,
      notably MERS-CoV, its spread is considerably big. As a result, the number of patients
      developing respiratory distress requiring invasive mechanical ventilation is high, with
      prolonged ventilation duration in these situations
Patients requiring invasive mechanical ventilation are at risk of secondary, nosocomial, a
      hospitalization in the ICU service and can affect up to 40% of ventilated patients. The
      occurrence of ventilator-associated pneumonia is associated with an increase in the duration
      of mechanical ventilation and its effect on mortality remains uncertain under general
      conditions. The mechanisms underlying the occurrence of lower respiratory infection during
      invasive mechanical ventilation are numerous, depending for the most part on two distinct
      elements: the occurrence of transcolonisation, which will secondarily promote colonisation of
      the lower respiratory tract, and the modification of the competence of the immune system in
      its response to aggression by microbial agents whose pathogenicity is highly variable.

      Throughout the infection by SARS-CoV2, the theoretical risk of secondary respiratory
      infection during mechanical ventilation is important due to the intrication of three
      concomitant phenomena: direct pulmonary aggression, which will alter the functionality of
      local immunity, the "cytokinic storm", responsible for the severity of the respiratory
      picture that motivated intubation and the need for mechanical ventilation leading inevitably
      to transcolonisation. Despite all of these pathophysiological arguments, very little data are
      available on the possibility of secondary low respiratory tract infection occurring during
      SARS-CoV2 infection and more generally during Coronarivus infections. even though all of
      these elements are well known and widely studied, very little data are currently available on
      the potential interaction between Coronaviruses and bacteria. The importance of this issue is
      very significant as recent observations tend to show a relative rarity of the occurrence of
      secondary lung infections during mechanical ventilation and the population of smokers,
      subject to chronic obstructive bronchitis (usually particularly susceptible to bacterial
      superinfections), does not appear to be more affected than that of non-smokers although the
      current data are very partial.

      The research is prospective, non interventional study that involves patients suffering from
      another severe form a COVID-19 infection: the nosocomial pneumonia under mechanical
      ventilation
observational model: Other
time perspective: Prospective
measure: Research of the bacteria responsible for nosocomial pneumonia
time frame: 6 months
description: Establishing a biobank of the bacterial agents responsible for nosocomial pneumonia acquired under mechanical ventilation in order to: better understand the particularities of the bacteria responsible and obtain the "clinical" strains for in vitro studies that will be carried out secondarily.
measure: Additional evaluations to the study
time frame: 6 months
description: Evaluation of the adhesion properties to the bronchial epithelium (LPS peculiarities of Gram-negative bacteria, the interaction with the virus in in vitro models and the different molecules of interest in the collected bronchial secretions).
During the inclusion, a 4 ml citrate tube of blood in addition to the usual management
      assessment and aspiration of tracheal secretions will be performed at D1, D3 and D7. Tracheal
      aspiration is performed systematically in order to limit patient congestion and the risk of
      atelectasis.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: François PHILLIPART, MD
role: Principal Investigator
affiliation: Fondation Hôpital Saint-Joseph
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Pneumonia, Ventilator-Associated
mesh term: Healthcare-Associated Pneumonia
mesh term: Coinfection