<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/NCT04439617</url>
  </required_header>
  <id_info>
    <org_study_id>QUENOT 2019</org_study_id>
    <nct_id>NCT04439617</nct_id>
  </id_info>
  <brief_title>Monitoring of the Mitochondrial Function of Circulating Myeloid Cells in Patients Hospitalized in the Intensive Care Unit of Dijon University Hospital</brief_title>
  <acronym>Myelochondria</acronym>
  <official_title>Monitoring of the Mitochondrial Function of Circulating Myeloid Cells in Patients Hospitalized in the Intensive Care Unit of Dijon University Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Severe infections (sepsis) are a common cause of admission to the intensive care unit. They&#xD;
      represent a significant health risk for patients in the short and medium term. They are&#xD;
      particularly linked to a change in the function of immune cells. In some patients, a state of&#xD;
      pseudo-dormancy of monocyte and macrophage-type immune cells, called immunosuppression of&#xD;
      myeloid cells, is observed. This situation leads to a worsening of the infection, so it&#xD;
      should be avoided because it represents a danger for the patient even when they ar receiving&#xD;
      antibiotics. At present, these events are still very poorly understood. Research is essential&#xD;
      to understand how this state of immunosuppression of myeloid cells is established in order to&#xD;
      adapt existing treatments or find new ones.&#xD;
&#xD;
      Laboratory studies on animal models of septicaemia have shown that this state of&#xD;
      immunosuppression of myeloid cells is closely linked to a change in the production of energy&#xD;
      by myeloid cells (monocytes and macrophages). The functioning of the mitochondria (&quot;energy&#xD;
      factory&quot; of the cells) in these cells is impaired. Thus, restoring mitochondrial function in&#xD;
      myeloid cells could be a therapeutic solution against the immunosuppression of myeloid cells&#xD;
      during severe septicaemia.&#xD;
&#xD;
      The objective of this study is to verify whether alterations in mitochondrial function in&#xD;
      myeloid cells also occur in patients with bacterial infection compared to patients without&#xD;
      bacterial infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Actual">March 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Level of mitophagy in circulating monocytes</measure>
    <time_frame>&lt;24 hours after hospitalization in intensive care</time_frame>
    <description>Measurement of mitochondrial density and PINK1 protein expression by flow cytometry in circulating monocytes (total population and subpopulation of conventional, intermediate and non-conventional monocytes (CD33, CD16 and CD14 monocyte markers)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">36</enrollment>
  <condition>Septicaemia</condition>
  <arm_group>
    <arm_group_label>sepsis patient</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Sepsis-free patient</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>blood examination</intervention_name>
    <description>use of the remaining 1-2 ml of blood in samples taken as part of routine care to study mitochondrial function</description>
    <arm_group_label>Sepsis-free patient</arm_group_label>
    <arm_group_label>sepsis patient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients hospitalized in the ICU with or without sepsis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult person who has given written consent (or consent obtained from a heath care&#xD;
             proxy) hospitalized in an ICU with or without sepsis (with or without infection)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Person not affiliated or not benefiting from national health insurance&#xD;
&#xD;
          -  Person under legal protection (curatorship, guardianship, safeguard of justice)&#xD;
&#xD;
          -  Pregnant, parturient or breastfeeding woman&#xD;
&#xD;
          -  Patient who was hospitalized within 3 months prior to inclusion for sepsis.&#xD;
&#xD;
          -  Patients receiving known treatment for mitochondrial function modulation,&#xD;
             mitochondrial biogenesis or mitophagy (chloroquine, hydroxychloroquine, rapamycin,&#xD;
             carbamazepine, resveratrol, sildenafil).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</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>Sepsis</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/NCT04439617
org study id: QUENOT 2019
nct id: NCT04439617
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Severe infections (sepsis) are a common cause of admission to the intensive care unit. They
      represent a significant health risk for patients in the short and medium term. They are
      particularly linked to a change in the function of immune cells. In some patients, a state of
      pseudo-dormancy of monocyte and macrophage-type immune cells, called immunosuppression of
      myeloid cells, is observed. This situation leads to a worsening of the infection, so it
      should be avoided because it represents a danger for the patient even when they ar receiving
      antibiotics. At present, these events are still very poorly understood. Research is essential
      to understand how this state of immunosuppression of myeloid cells is established in order to
      adapt existing treatments or find new ones.

      Laboratory studies on animal models of septicaemia have shown that this state of
      immunosuppression of myeloid cells is closely linked to a change in the production of energy
      by myeloid cells (monocytes and macrophages). The functioning of the mitochondria ("energy
      factory" of the cells) in these cells is impaired. Thus, restoring mitochondrial function in
      myeloid cells could be a therapeutic solution against the immunosuppression of myeloid cells
      during severe septicaemia.

      The objective of this study is to verify whether alterations in mitochondrial function in
      myeloid cells also occur in patients with bacterial infection compared to patients without
      bacterial infection.
observational model: Case-Control
time perspective: Prospective
measure: Level of mitophagy in circulating monocytes
time frame: <24 hours after hospitalization in intensive care
description: Measurement of mitochondrial density and PINK1 protein expression by flow cytometry in circulating monocytes (total population and subpopulation of conventional, intermediate and non-conventional monocytes (CD33, CD16 and CD14 monocyte markers)
arm group label: sepsis patient
arm group label: Sepsis-free patient
intervention type: Biological
intervention name: blood examination
description: use of the remaining 1-2 ml of blood in samples taken as part of routine care to study mitochondrial function
arm group label: Sepsis-free patient
arm group label: sepsis patient
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Sepsis