<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/NCT04438460</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL20_0068</org_study_id>
    <secondary_id>2020-A00343-36</secondary_id>
    <nct_id>NCT04438460</nct_id>
  </id_info>
  <brief_title>Pediatric Immune Response to Multi-Organ Dysfunction</brief_title>
  <acronym>PedIMOD</acronym>
  <official_title>Pediatric Immune Response to Multi-Organ Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      Multiple organ dysfunction (MOD) is defined by the association of at least two failures of&#xD;
      vital organs, with various etiologies (septic shock, polytrauma, acute respiratory distress&#xD;
      syndrome, etc.). Associated mortality remains high in children (between 20 and 50%).&#xD;
&#xD;
      In septic shock, one of the main causes of MOD, induced immunosuppression can occur, with&#xD;
      immune alterations affecting all cells of immunity. This induced immunosuppression is&#xD;
      associated with an additional risk of secondary acquired infections and death in adults.&#xD;
      Among all the cells and all the markers studied, the expression of Human Leukocyte Antigen -&#xD;
      DR isotype (HLA-DR) on the surface of the monocyte (mHLA-DR, expressed in number of sites per&#xD;
      cell) appeared as one of the best biomarkers of this induced immunosuppression. Decreased&#xD;
      expression of monocyte Human Leukocyte Antigen - DR isotype (mHLA-DR) in adults is linked to&#xD;
      an increased risk of developing secondary infection and death.&#xD;
&#xD;
      These results were confirmed by team in the context of pediatric septic shock, with an attack&#xD;
      of innate immunity in the foreground. Persistent lowering of mHLA-DR for more than 3 days&#xD;
      after onset of shock was associated with the occurrence of secondary acquired infections: 50%&#xD;
      of children had mHLA-DR of less than 8000 sites / cells on D3, of which 60 % developed&#xD;
      secondary infection within 30 days. No child with mHLA-DR greater than 8000 sites / cells had&#xD;
      secondary infection.&#xD;
&#xD;
      Such immune alterations appear to be non-specific for septic shock, as they have also been&#xD;
      described after multiple trauma or severe respiratory infections.&#xD;
&#xD;
      The hypothesize is that multi-systemic aggression leading to multi-visceral failure syndrome&#xD;
      could also lead to significant immunosuppression, regardless of the etiology of this MOD.&#xD;
&#xD;
      At present, the proportion of persistent immunosuppression induced by MOD, all etiologies&#xD;
      combined, is poorly documented in pediatrics. Estimating this proportion in a large pediatric&#xD;
      cohort, while exploring as fully as possible the associated immune alterations and acquired&#xD;
      secondary infections, would improve the pathophysiological understanding and pediatric&#xD;
      specificities of this phenomenon.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 29, 2020</start_date>
  <completion_date type="Anticipated">September 29, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 29, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mHLA-DR measurement</measure>
    <time_frame>Day 3</time_frame>
    <description>The proportion of children with mHLA-DR &lt; 8000 sites / cells on Day 3 - Day 5 will be compared between the groups &quot;secondary acquired infections&quot; and &quot;no secondary acquired infection&quot; occurring within 2 months. The diagnosis of secondary acquired infection will be made by an independent committee.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood counts : Characterization of alterations in the myeloid lineage</measure>
    <time_frame>Day 1</time_frame>
    <description>Blood cell counts will be compared between the groups &quot;secondary acquired infections&quot; and &quot;no secondary acquired infection&quot; occurring within 2 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mHLA-DR expression : Characterization of alterations in the myeloid lineage</measure>
    <time_frame>Day 1</time_frame>
    <description>mHLA-DR expressed as a number of site / cell will be compared between the groups &quot;secondary acquired infections&quot; and &quot;no secondary acquired infection&quot; occurring within 2 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>transcriptome : Characterization of alterations in the myeloid lineage</measure>
    <time_frame>Day 1</time_frame>
    <description>Gene expression through messenger ribonucleic acid (mRNA) analysis will be compared between the groups &quot;secondary acquired infections&quot; and &quot;no secondary acquired infection&quot; occurring within 2 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma cytokines : Characterization of alterations in the myeloid lineage</measure>
    <time_frame>Day 1</time_frame>
    <description>Cytokine levels will be compared between the groups &quot;secondary acquired infections&quot; and &quot;no secondary acquired infection&quot; occurring within 2 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood counts : Characterization of alterations in the myeloid lineage</measure>
    <time_frame>Day 3</time_frame>
    <description>Blood cell counts will be compared between the groups &quot;secondary acquired infections&quot; and &quot;no secondary acquired infection&quot; occurring within 2 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mHLA-DR expression : Characterization of alterations in the myeloid lineage</measure>
    <time_frame>Day 3</time_frame>
    <description>mHLA-DR expressed as a number of site / cell will be compared between the groups &quot;secondary acquired infections&quot; and &quot;no secondary acquired infection&quot; occurring within 2 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>transcriptome : Characterization of alterations in the myeloid lineage</measure>
    <time_frame>Day 3</time_frame>
    <description>Gene expression through messenger ribonucleic acid (mRNA) analysis will be compared between the groups &quot;secondary acquired infections&quot; and &quot;no secondary acquired infection&quot; occurring within 2 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma cytokines : Characterization of alterations in the myeloid lineage</measure>
    <time_frame>Day 3</time_frame>
    <description>Cytokine levels will be compared between the groups &quot;secondary acquired infections&quot; and &quot;no secondary acquired infection&quot; occurring within 2 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood counts : Characterization of alterations in the myeloid lineage</measure>
    <time_frame>Day 60</time_frame>
    <description>Blood cell counts will be compared between the groups &quot;secondary acquired infections&quot; and &quot;no secondary acquired infection&quot; occurring within 2 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mHLA-DR expression : Characterization of alterations in the myeloid lineage</measure>
    <time_frame>Day 60</time_frame>
    <description>mHLA-DR expressed as a number of site / cell will be compared between the groups &quot;secondary acquired infections&quot; and &quot;no secondary acquired infection&quot; occurring within 2 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>transcriptome : Characterization of alterations in the myeloid lineage</measure>
    <time_frame>Day 60</time_frame>
    <description>Gene expression through messenger ribonucleic acid (mRNA) analysis will be compared between the groups &quot;secondary acquired infections&quot; and &quot;no secondary acquired infection&quot; occurring within 2 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma cytokines : Characterization of alterations in the myeloid lineage</measure>
    <time_frame>Day 60</time_frame>
    <description>Cytokine levels will be compared between the groups &quot;secondary acquired infections&quot; and &quot;no secondary acquired infection&quot; occurring within 2 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary acquired infection</measure>
    <time_frame>Day 60</time_frame>
    <description>The incidence of secondary acquired infections occurring within 2 months will be compared between the groups &quot;immunosuppression&quot; and &quot;no immunosuppression&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mHLA-DR measurement</measure>
    <time_frame>Day 60</time_frame>
    <description>Evaluation of the immunological recovery at month 2 with regard to the initial state and in comparison with the controls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myeloid Derived Suppressor Cells (MDSC) measurement</measure>
    <time_frame>Day 1</time_frame>
    <description>Characterization of MDSC will be measured and compared between patient and control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-cellular production of tumor necrosis factor alpha (TNFα) by the monocyte</measure>
    <time_frame>Day 1</time_frame>
    <description>Evaluate the feasibility of a new test : measure of the intra-cellular production of TNF α by the monocyte. It will be compared between patient and control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MDSC measurement</measure>
    <time_frame>Day 3</time_frame>
    <description>Characterization of MDSC will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-cellular production of TNFα by the monocyte</measure>
    <time_frame>Day 3</time_frame>
    <description>Evaluate the feasibility of a new test : measure of the intra-cellular production of TNF α by the monocyte.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monocytic and dendritic subpopulations measurement</measure>
    <time_frame>Day 1</time_frame>
    <description>Characterization of monocytic and dendritic subpopulations will be realized and compared between patient and control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gamma-delta T lymphocytes measurement</measure>
    <time_frame>Day 1</time_frame>
    <description>Characterization of gamma-delta T lymphocytes will be realized and compared between patient and control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monocytic and dendritic subpopulations measurement</measure>
    <time_frame>Day 3</time_frame>
    <description>Characterization of monocytic and dendritic subpopulations will be realized</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gamma-delta T lymphocytes measurement</measure>
    <time_frame>Day 3</time_frame>
    <description>Characterization of gamma-delta T lymphocytes will be realized</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monocytic and dendritic subpopulations measurement</measure>
    <time_frame>Day 60</time_frame>
    <description>Characterization of monocytic and dendritic subpopulations will be realized</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gamma-delta T lymphocytes measurement</measure>
    <time_frame>Day 60</time_frame>
    <description>Characterization of gamma-delta T lymphocytes will be realized</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">210</enrollment>
  <condition>Multiple Organ Dysfunction Syndrome</condition>
  <arm_group>
    <arm_group_label>Patient group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>150 children aged 1 month to 12 years with multi-visceral failure syndrome within 48 hours of hospitalization in pediatric resuscitation will be included in this study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>60 children aged 1 month to 12 years hospitalized for simple elective surgery will be included in this study</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood test</intervention_name>
    <description>For patient group, blood tests will be performed at day 1-2, day 3-5 and day 60.&#xD;
For control group, blood test will be performed the day of elective surgery.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Patient group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient Group:&#xD;
&#xD;
          -  1 month &lt; Age &lt; 12 years&#xD;
&#xD;
          -  Multiple organ dysfunction within 48 hours following intensive care unit admission&#xD;
&#xD;
          -  Beneficiary of a social security scheme.&#xD;
&#xD;
          -  Consent signed by at least one parent / holder of parental authority&#xD;
&#xD;
        Control Group:&#xD;
&#xD;
          -  1 month &lt; Age &lt; 12 years&#xD;
&#xD;
          -  Hospitalized for simple elective surgery&#xD;
&#xD;
          -  Beneficiary of a social security scheme.&#xD;
&#xD;
          -  Consent signed by at least one parent / holder of parental authority&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient Group:&#xD;
&#xD;
          -  Weight &lt; 5 kg&#xD;
&#xD;
          -  Known immunosuppression&#xD;
&#xD;
          -  Prolonged corticotherapy&#xD;
&#xD;
          -  Chronic inflammatory disease&#xD;
&#xD;
          -  Malignant pathology with ongoing treatment&#xD;
&#xD;
          -  Hepatic cirrhosis&#xD;
&#xD;
          -  Polymerase Chain Reaction (PCR) Severe acute respiratory syndrome coronavirus&#xD;
             (SARS-CoV-2) positive or patient with Pediatric Inflammatory Multisystem Syndrome&#xD;
             (PIMS)&#xD;
&#xD;
          -  Pediatric inflammatory multisystem syndrome (PIMS)&#xD;
&#xD;
        Control Group:&#xD;
&#xD;
          -  Weight &lt; 5 kg&#xD;
&#xD;
          -  Known immunosuppression&#xD;
&#xD;
          -  Prolonged corticotherapy&#xD;
&#xD;
          -  Chronic inflammatory disease&#xD;
&#xD;
          -  Malignant pathology with ongoing treatment&#xD;
&#xD;
          -  Ongoing infection&#xD;
&#xD;
          -  Organ failure&#xD;
&#xD;
          -  Hepatic cirrhosis&#xD;
&#xD;
          -  PCR SARS-CoV-2 positive or patient with Pediatric Inflammatory Multisystem Syndrome&#xD;
             (PIMS)&#xD;
&#xD;
          -  Pediatric inflammatory multisystem syndrome (PIMS)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Solenn REMY, MD, PhD</last_name>
    <phone>0472 129 746</phone>
    <phone_ext>+33</phone_ext>
    <email>solene.remy@chu-lyon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tiphanie Ginhoux</last_name>
    <phone>0427 857 723</phone>
    <phone_ext>+33</phone_ext>
    <email>tiphanie.ginhoux01@chu-lyon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital Femme Mère Enfant</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Solenn REMY, MD,PhD</last_name>
      <phone>0472 129 746</phone>
      <phone_ext>+33</phone_ext>
      <email>solene.remy@chu-lyon.fr</email>
    </contact>
    <contact_backup>
      <last_name>Tiphanie Ginhoux</last_name>
      <phone>0427 857 723</phone>
      <phone_ext>+33</phone_ext>
      <email>tiphanie.ginhoux@chu-lyon.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Solenn REMY, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Etienne JAVOUHEY, PU, PH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dominique CHASSARD, PU, PH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hopital Mère Enfant</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Alexis Chenouard, MD, PhD</last_name>
      <phone>02.40.08.34.83</phone>
      <phone_ext>+33</phone_ext>
      <email>Alexis.CHENOUARD@chu-nantes.fr</email>
    </contact>
    <investigator>
      <last_name>Alexis Chenouard, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 12, 2023</last_update_submitted>
  <last_update_submitted_qc>June 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple organ dysfunction</keyword>
  <keyword>Immunosuppression</keyword>
  <keyword>mHLA-DR</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>Secondary infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Organ Failure</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/NCT04438460
org study id: 69HCL20_0068
secondary id: 2020-A00343-36
nct id: NCT04438460
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multiple organ dysfunction (MOD) is defined by the association of at least two failures of
      vital organs, with various etiologies (septic shock, polytrauma, acute respiratory distress
      syndrome, etc.). Associated mortality remains high in children (between 20 and 50%).

      In septic shock, one of the main causes of MOD, induced immunosuppression can occur, with
      immune alterations affecting all cells of immunity. This induced immunosuppression is
      associated with an additional risk of secondary acquired infections and death in adults.
      Among all the cells and all the markers studied, the expression of Human Leukocyte Antigen -
      DR isotype (HLA-DR) on the surface of the monocyte (mHLA-DR, expressed in number of sites per
      cell) appeared as one of the best biomarkers of this induced immunosuppression. Decreased
      expression of monocyte Human Leukocyte Antigen - DR isotype (mHLA-DR) in adults is linked to
      an increased risk of developing secondary infection and death.

      These results were confirmed by team in the context of pediatric septic shock, with an attack
      of innate immunity in the foreground. Persistent lowering of mHLA-DR for more than 3 days
      after onset of shock was associated with the occurrence of secondary acquired infections: 50%
      of children had mHLA-DR of less than 8000 sites / cells on D3, of which 60 % developed
      secondary infection within 30 days. No child with mHLA-DR greater than 8000 sites / cells had
      secondary infection.

      Such immune alterations appear to be non-specific for septic shock, as they have also been
      described after multiple trauma or severe respiratory infections.

      The hypothesize is that multi-systemic aggression leading to multi-visceral failure syndrome
      could also lead to significant immunosuppression, regardless of the etiology of this MOD.

      At present, the proportion of persistent immunosuppression induced by MOD, all etiologies
      combined, is poorly documented in pediatrics. Estimating this proportion in a large pediatric
      cohort, while exploring as fully as possible the associated immune alterations and acquired
      secondary infections, would improve the pathophysiological understanding and pediatric
      specificities of this phenomenon.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: mHLA-DR measurement
time frame: Day 3
description: The proportion of children with mHLA-DR < 8000 sites / cells on Day 3 - Day 5 will be compared between the groups "secondary acquired infections" and "no secondary acquired infection" occurring within 2 months. The diagnosis of secondary acquired infection will be made by an independent committee.
measure: blood counts : Characterization of alterations in the myeloid lineage
time frame: Day 1
description: Blood cell counts will be compared between the groups "secondary acquired infections" and "no secondary acquired infection" occurring within 2 months.
measure: mHLA-DR expression : Characterization of alterations in the myeloid lineage
time frame: Day 1
description: mHLA-DR expressed as a number of site / cell will be compared between the groups "secondary acquired infections" and "no secondary acquired infection" occurring within 2 months
measure: transcriptome : Characterization of alterations in the myeloid lineage
time frame: Day 1
description: Gene expression through messenger ribonucleic acid (mRNA) analysis will be compared between the groups "secondary acquired infections" and "no secondary acquired infection" occurring within 2 months.
measure: plasma cytokines : Characterization of alterations in the myeloid lineage
time frame: Day 1
description: Cytokine levels will be compared between the groups "secondary acquired infections" and "no secondary acquired infection" occurring within 2 months.
measure: blood counts : Characterization of alterations in the myeloid lineage
time frame: Day 3
description: Blood cell counts will be compared between the groups "secondary acquired infections" and "no secondary acquired infection" occurring within 2 months
measure: mHLA-DR expression : Characterization of alterations in the myeloid lineage
time frame: Day 3
description: mHLA-DR expressed as a number of site / cell will be compared between the groups "secondary acquired infections" and "no secondary acquired infection" occurring within 2 months.
measure: transcriptome : Characterization of alterations in the myeloid lineage
time frame: Day 3
description: Gene expression through messenger ribonucleic acid (mRNA) analysis will be compared between the groups "secondary acquired infections" and "no secondary acquired infection" occurring within 2 months.
measure: plasma cytokines : Characterization of alterations in the myeloid lineage
time frame: Day 3
description: Cytokine levels will be compared between the groups "secondary acquired infections" and "no secondary acquired infection" occurring within 2 months.
measure: blood counts : Characterization of alterations in the myeloid lineage
time frame: Day 60
description: Blood cell counts will be compared between the groups "secondary acquired infections" and "no secondary acquired infection" occurring within 2 months.
measure: mHLA-DR expression : Characterization of alterations in the myeloid lineage
time frame: Day 60
description: mHLA-DR expressed as a number of site / cell will be compared between the groups "secondary acquired infections" and "no secondary acquired infection" occurring within 2 months.
measure: transcriptome : Characterization of alterations in the myeloid lineage
time frame: Day 60
description: Gene expression through messenger ribonucleic acid (mRNA) analysis will be compared between the groups "secondary acquired infections" and "no secondary acquired infection" occurring within 2 months.
measure: plasma cytokines : Characterization of alterations in the myeloid lineage
time frame: Day 60
description: Cytokine levels will be compared between the groups "secondary acquired infections" and "no secondary acquired infection" occurring within 2 months.
measure: Secondary acquired infection
time frame: Day 60
description: The incidence of secondary acquired infections occurring within 2 months will be compared between the groups "immunosuppression" and "no immunosuppression".
measure: mHLA-DR measurement
time frame: Day 60
description: Evaluation of the immunological recovery at month 2 with regard to the initial state and in comparison with the controls.
measure: Myeloid Derived Suppressor Cells (MDSC) measurement
time frame: Day 1
description: Characterization of MDSC will be measured and compared between patient and control
measure: Intra-cellular production of tumor necrosis factor alpha (TNFα) by the monocyte
time frame: Day 1
description: Evaluate the feasibility of a new test : measure of the intra-cellular production of TNF α by the monocyte. It will be compared between patient and control.
measure: MDSC measurement
time frame: Day 3
description: Characterization of MDSC will be measured
measure: Intra-cellular production of TNFα by the monocyte
time frame: Day 3
description: Evaluate the feasibility of a new test : measure of the intra-cellular production of TNF α by the monocyte.
measure: Monocytic and dendritic subpopulations measurement
time frame: Day 1
description: Characterization of monocytic and dendritic subpopulations will be realized and compared between patient and control.
measure: Gamma-delta T lymphocytes measurement
time frame: Day 1
description: Characterization of gamma-delta T lymphocytes will be realized and compared between patient and control.
measure: Monocytic and dendritic subpopulations measurement
time frame: Day 3
description: Characterization of monocytic and dendritic subpopulations will be realized
measure: Gamma-delta T lymphocytes measurement
time frame: Day 3
description: Characterization of gamma-delta T lymphocytes will be realized
measure: Monocytic and dendritic subpopulations measurement
time frame: Day 60
description: Characterization of monocytic and dendritic subpopulations will be realized
measure: Gamma-delta T lymphocytes measurement
time frame: Day 60
description: Characterization of gamma-delta T lymphocytes will be realized
arm group label: Patient group
arm group type: Experimental
description: 150 children aged 1 month to 12 years with multi-visceral failure syndrome within 48 hours of hospitalization in pediatric resuscitation will be included in this study
arm group label: Control group
arm group type: Other
description: 60 children aged 1 month to 12 years hospitalized for simple elective surgery will be included in this study
intervention type: Biological
intervention name: Blood test
description: For patient group, blood tests will be performed at day 1-2, day 3-5 and day 60.
For control group, blood test will be performed the day of elective surgery.
arm group label: Control group
arm group label: Patient group
criteria: 
gender: All
minimum age: 1 Month
maximum age: 12 Years
healthy volunteers: No
last name: Solenn REMY, MD, PhD
phone: 0472 129 746
phone ext: +33
email: solene.remy@chu-lyon.fr
last name: Tiphanie Ginhoux
phone: 0427 857 723
phone ext: +33
email: tiphanie.ginhoux01@chu-lyon.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Multiple Organ Failure