<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/NCT04469348</url>
  </required_header>
  <id_info>
    <org_study_id>19CH050</org_study_id>
    <secondary_id>2020-A00321-38</secondary_id>
    <nct_id>NCT04469348</nct_id>
  </id_info>
  <brief_title>Inflammation, Intracellular Invasion and Colonization of the Nasal Mucosa by Staphylococcus Aureus</brief_title>
  <acronym>I3COSa</acronym>
  <official_title>Inflammation, Intracellular Invasion and Colonization of the Nasal Mucosa by Staphylococcus Aureus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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>
      An inflammatory state of the nasal cells (very close to keratinocytes) could favour the&#xD;
      internalization of Staphylococcus aureus and thus constitute a persistent reservoir for the&#xD;
      carriage of this bacterium.&#xD;
&#xD;
      Staphylococcus aureus is a commensal bacterium of the skin and mucous membranes that&#xD;
      colonizes approximately 2 billion people worldwide Staphylococcus aureus is also a leading&#xD;
      cause of community and healthcare-associated infection. Staphylococcus aureus has&#xD;
      demonstrated its ability to invade many non-professional phagocytic cell lines such as&#xD;
      keratinocytes, osteoblasts, fibroblasts, epithelial cells and endothelial cells. During&#xD;
      pro-inflammatory stimulation, internalization of Staphylococcus aureus into keratinocytes is&#xD;
      mainly mediated by ICAM-1. These results suggest that, in humans, an inflammatory state of&#xD;
      the nasal cells (very close to keratinocytes) could promote the internalization of&#xD;
      Staphylococcus aureus and thus constitute a persistent reservoir for the carriage of this&#xD;
      bacterium.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective is to compare the expression level of ICAM-1 in nasal cells with and&#xD;
      without the presence of Staphylococcus aureus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 18, 2021</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>level of ICAM-1 expression in nasal cells</measure>
    <time_frame>Months: 0</time_frame>
    <description>Compare the level of ICAM-1 expression in nasal cells with and without the presence of intracellular Staphylococcus aureus</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of the expression of the genes (mRNA dosage) involved in IL-1 beta secretion</measure>
    <time_frame>Months: 0</time_frame>
    <description>Measure by rt-qPCR technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of the expression of the genes (mRNA dosage) involved in activation of autophagy</measure>
    <time_frame>Months: 0</time_frame>
    <description>Measure by rt-qPCR technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cytokine concentration</measure>
    <time_frame>Months: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12</time_frame>
    <description>Measure by analysis of nasal swab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>concentration of ICAM-1 in S. Aureus</measure>
    <time_frame>Months: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12</time_frame>
    <description>Measure by analysis of nasal swab.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">157</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy volunteers will be included. They will have nasal swab at the inclusion visit to detect contamination of S. Aureus.&#xD;
If contamination of S. Aureus: they will have 12 follow-up visits (1 per month)&#xD;
If no contamination of S. Aureus: their participation stops</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>nasal swab</intervention_name>
    <description>nasal swab will be performed to analysis biological markers at every visit.</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject affiliated to a social security scheme or entitled person&#xD;
&#xD;
          -  Subject who received informed information about the study et signed consent&#xD;
&#xD;
          -  Adult subject (≥18ans)&#xD;
&#xD;
          -  Healthy Volunteer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject undergoing antibiotic treatment or having received antibiotic treatment (oral,&#xD;
             IV or local) in the month prior to inclusion&#xD;
&#xD;
          -  Subject with a major haemostasis disorder or anticoagulant treatment contraindicated&#xD;
             for surgery&#xD;
&#xD;
          -  Subject with a pathology increasing the nasal carriage of S. aureus (chronic&#xD;
             furunculosis, diabetes, HIV infection, chronic rhinosinusitis)&#xD;
&#xD;
          -  Subject under guardianship or trusteeship&#xD;
&#xD;
          -  Pregnant woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Verhoeven, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paul Verhoeven, MD</last_name>
    <phone>(0)4 77 82 92 28</phone>
    <phone_ext>+33</phone_ext>
    <email>paul.verhoeven@chu-st-etienne.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Florence RANCON, CRA</last_name>
    <phone>(0)4 77 82 94 58</phone>
    <phone_ext>+33</phone_ext>
    <email>florence.rancon@chu-st-etienne.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU de Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Paul Verhoeven, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bruno Pozzetto, MD - PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Philippe Berthelot, MD - PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Elisabeth Botelho-Nevers, MD - PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>November 29, 2022</last_update_submitted>
  <last_update_submitted_qc>November 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Staphylococcus aureus</keyword>
  <keyword>ICAM-1</keyword>
  <keyword>nasal cells</keyword>
  <keyword>S. aureus</keyword>
  <keyword>nasal swab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</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/NCT04469348
org study id: 19CH050
secondary id: 2020-A00321-38
nct id: NCT04469348
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An inflammatory state of the nasal cells (very close to keratinocytes) could favour the
      internalization of Staphylococcus aureus and thus constitute a persistent reservoir for the
      carriage of this bacterium.

      Staphylococcus aureus is a commensal bacterium of the skin and mucous membranes that
      colonizes approximately 2 billion people worldwide Staphylococcus aureus is also a leading
      cause of community and healthcare-associated infection. Staphylococcus aureus has
      demonstrated its ability to invade many non-professional phagocytic cell lines such as
      keratinocytes, osteoblasts, fibroblasts, epithelial cells and endothelial cells. During
      pro-inflammatory stimulation, internalization of Staphylococcus aureus into keratinocytes is
      mainly mediated by ICAM-1. These results suggest that, in humans, an inflammatory state of
      the nasal cells (very close to keratinocytes) could promote the internalization of
      Staphylococcus aureus and thus constitute a persistent reservoir for the carriage of this
      bacterium.
The main objective is to compare the expression level of ICAM-1 in nasal cells with and
      without the presence of Staphylococcus aureus.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: level of ICAM-1 expression in nasal cells
time frame: Months: 0
description: Compare the level of ICAM-1 expression in nasal cells with and without the presence of intracellular Staphylococcus aureus
measure: Measurement of the expression of the genes (mRNA dosage) involved in IL-1 beta secretion
time frame: Months: 0
description: Measure by rt-qPCR technique.
measure: Measurement of the expression of the genes (mRNA dosage) involved in activation of autophagy
time frame: Months: 0
description: Measure by rt-qPCR technique.
measure: cytokine concentration
time frame: Months: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
description: Measure by analysis of nasal swab.
measure: concentration of ICAM-1 in S. Aureus
time frame: Months: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
description: Measure by analysis of nasal swab.
arm group label: Healthy volunteers
arm group type: Experimental
description: Healthy volunteers will be included. They will have nasal swab at the inclusion visit to detect contamination of S. Aureus.
If contamination of S. Aureus: they will have 12 follow-up visits (1 per month)
If no contamination of S. Aureus: their participation stops
intervention type: Diagnostic Test
intervention name: nasal swab
description: nasal swab will be performed to analysis biological markers at every visit.
arm group label: Healthy volunteers
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Paul Verhoeven, MD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
last name: Paul Verhoeven, MD
phone: (0)4 77 82 92 28
phone ext: +33
email: paul.verhoeven@chu-st-etienne.fr
last name: Florence RANCON, CRA
phone: (0)4 77 82 94 58
phone ext: +33
email: florence.rancon@chu-st-etienne.fr
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Inflammation
sharing ipd: No