<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/NCT03827759</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0293</org_study_id>
    <secondary_id>7683</secondary_id>
    <nct_id>NCT03827759</nct_id>
  </id_info>
  <brief_title>Differentiate Children Septic and Inflammatory Arthritis by Comparative Analysis</brief_title>
  <acronym>DIANE</acronym>
  <official_title>Multicenter, Diagnostic and Prospective Study to Differentiate Child Septic and Inflammatory Arthritis by Comparative Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>INSERM U1183</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</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 purpose is to found new biomarker that differentiate septic arthritis and Juvenile&#xD;
      Idiopathic Arthritis in children. Synovial liquid and blood samples with proteomic, MiRNA&#xD;
      searching, multiplex cytokine analysis and cellular phenotyping, will be analysed. The&#xD;
      results for each data will be compared in function of the disease to search discriminant&#xD;
      markers. On behalf with this result specific pathways could be identified .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This a multicentric prospective study that compares biological fluids as synovial liquid and&#xD;
      blood samples to find biomarkers that could distinguish septic arthritis and juvenile&#xD;
      idiopathic arthritis. Prospectively, patients will be recruited under the age of 15 who are&#xD;
      in care for septic or inflammatory arthritis at the University Hospitals of Montpellier,&#xD;
      Lyon, Nimes and Toulouse. Patients should have an indication of blood and synovial as part of&#xD;
      their management :&#xD;
&#xD;
      Group A: acute juvenile arthritis with suspicion of bacterial infection, , confirmed on a&#xD;
      bacteriological plan, either by culture of the articular liquid or by blood culture, or by&#xD;
      molecular biology in the articular liquid.&#xD;
&#xD;
      Group B: Idiopathic juvenile arthritis and control topics (Group C). In this project, the aim&#xD;
      is to analyze all in all 50 articular liquids and serum of inflammatory arthritises (Group&#xD;
      B), and 30 articular liquids and serum of infectious confirmed arthritises (Group A) which&#xD;
      will require the inclusion about 50 possibly septic arthritis. The diagnosis of infectious&#xD;
      arthritis is not immediate, he(it) is confirmed at the latest three weeks after the draining.&#xD;
      So a group of control will be constituted.&#xD;
&#xD;
      Group C: the blood of 20 healthy children matched by the age and at the sex in the groups A&#xD;
      and B will be collected to analyze elements studied in the blood.&#xD;
&#xD;
        -  Inclusion criteria :&#xD;
&#xD;
      Group A and group B:&#xD;
&#xD;
        -  Subject of more than 6 months and under age 15 years,&#xD;
&#xD;
        -  Presenting acute arthritis taken care in the University Hospitals of Montpellier, Nimes,&#xD;
           Toulouse or Lyon, and requiring an articular puncture&#xD;
&#xD;
        -  Child benefiting from a social security system,&#xD;
&#xD;
        -  Collection of the consent of the legal parents/representatives,&#xD;
&#xD;
      Group C:&#xD;
&#xD;
        -  Subject of more than 6 months and under age 15 include&#xD;
&#xD;
        -  Taken care in the University Hospital of Montpellier, and requiring a venous draining,&#xD;
&#xD;
        -  Child benefiting from a social security system,&#xD;
&#xD;
        -  Collection of the consent of the legal parents/representatives&#xD;
&#xD;
             -  Non inclusion criteria /&#xD;
&#xD;
      Group A and group B:&#xD;
&#xD;
        -  Contraindication in an articular draining: platelet 50 000/mm3, pathologic hemostasis&#xD;
&#xD;
        -  Treatment by biological therapy, corticoids or other immunosuppressant treatment in the&#xD;
           month preceding the articular draining,&#xD;
&#xD;
        -  antibiotic begun more than 24 hours before the inclusion.&#xD;
&#xD;
      Group C: ·&#xD;
&#xD;
        -  Patient achieves of an inflammatory chronic pathology&#xD;
&#xD;
        -  Patient having presented an infectious episode in the previous 8 days -Patients under&#xD;
           immunosuppressor or anti-infective&#xD;
&#xD;
      Methods of measure of assessment criteria&#xD;
&#xD;
      Analysis will be done on blood samples and synovial liquid, that remains after sample&#xD;
      collected for the management of their disease. The blood test and an synovial liquid draining&#xD;
      will be realized at the subject. Before freezing, aliquots will be realized so that every&#xD;
      analysis can benefit from a minimum volume:&#xD;
&#xD;
        -  Cellular analyses: will be only made in Montpellier and established by the set of&#xD;
           collected cells (no necessary volume).&#xD;
&#xD;
        -  Proteomic, MiRNA analysis and cytokine dosing will been done in the second time.&#xD;
&#xD;
      Statistical analysis will be done to individualize biomarkers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Anticipated">August 4, 2024</completion_date>
  <primary_completion_date type="Actual">July 25, 2022</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>Qualitative analysis of new biological markers (proteic) that discriminate inflammatory and infectious arthritis</measure>
    <time_frame>1 day</time_frame>
    <description>Identify blood sampling proteic markers of Arthritis childhood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative analysis of new biological markers (cytokine) that discriminate inflammatory and infectious arthritis</measure>
    <time_frame>1 day</time_frame>
    <description>Identify blood sampling markers (cytokine : interleukin 2, interleukin 4, interleukin 6, interleukin 7, tumor necrosis factor alpha (TNF)) of Arthritis childhood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative analysis of new cellular markers that discriminate inflammatory and infectious arthritis</measure>
    <time_frame>1 day</time_frame>
    <description>Identify blood sampling cellular markers (lymphocytes and monocytes) of Arthritis childhood</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Qualitative analysis of inflammatory process markers</measure>
    <time_frame>1 day</time_frame>
    <description>Identify articular liquid sampling biomarkers (lymphocytes and interleukins) of Arthritis childhood</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Septic Arthritis</condition>
  <condition>Inflammatory Arthritis</condition>
  <condition>Children</condition>
  <arm_group>
    <arm_group_label>septic arthritis (group A)</arm_group_label>
    <description>Patients with acute juvenile arthritis with suspicion of bacterial infection,confirmed on a bacteriological plan, either by culture of the articular liquid or by blood culture, or by molecular biology in the articular liquid;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>inflammatory arthritis (group B)</arm_group_label>
    <description>Patients with idiopathic juvenile arthritis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control (group C)</arm_group_label>
    <description>Healthy children who are matched by the age and at the sex in the groups A and B, to analyze elements studied in the blood.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Synovial liquid and blood samples (with : proteomic, MiRNA searching, multiplex cytokine&#xD;
      analysis and cellular phenotyping) will be analysed.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects of more than 6 months and under age 15 years, presenting acute arthritis, and&#xD;
        control subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Group A and group B:&#xD;
&#xD;
          -  Subject of more than 6 months and under age 15 years,&#xD;
&#xD;
          -  Presenting acute arthritis taken care in the University Hospitals of Montpellier,&#xD;
             Nimes, Toulouse or Lyon, and requiring an articular puncture,&#xD;
&#xD;
          -  Child benefiting from a social security system,&#xD;
&#xD;
          -  Collection of the consent of the legal parents/representatives,&#xD;
&#xD;
        Group C:&#xD;
&#xD;
          -  Subject of more than 6 months and under age 15 include,&#xD;
&#xD;
          -  Taken care in the University Hospital of Montpellier, and requiring a venous draining,&#xD;
&#xD;
          -  Child benefiting from a social security system,&#xD;
&#xD;
          -  Collection of the consent of the legal parents/representatives&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Group A and group B:&#xD;
&#xD;
          -  Contraindication in an articular draining: platelet 50 000/mm3, pathologic hemostasis&#xD;
&#xD;
          -  Treatment by biological therapy, corticoids or other immunosuppressant treatment in&#xD;
             the month preceding the articular draining,&#xD;
&#xD;
          -  antibiotic begun more than 24 hours before the inclusion.&#xD;
&#xD;
        Group C:&#xD;
&#xD;
          -  Patient achieves of an inflammatory chronic pathology&#xD;
&#xD;
          -  Patient having presented an infectious episode in the previous 8 days&#xD;
&#xD;
          -  Patients under immunosuppressor or anti-infective&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric JEZIORSKI, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Montpellier - Pediatric emergencies</name>
      <address>
        <city>Montpellier</city>
        <state>Hérault</state>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospices Civils de Lyon - pediatric rheumatology</name>
      <address>
        <city>Lyon</city>
        <zip>69002</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Joseph</name>
      <address>
        <city>Marseille</city>
        <zip>13285</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nîmes - Pediatrics</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse - Pediatric infectious diseases</name>
      <address>
        <city>Toulouse</city>
        <zip>31300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>November 18, 2022</last_update_submitted>
  <last_update_submitted_qc>November 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>idiopathic juvenile arthritis, septic arthritis, biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis, Infectious</mesh_term>
    <mesh_term>Arthritis</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/NCT03827759
org study id: RECHMPL18_0293
secondary id: 7683
nct id: NCT03827759
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose is to found new biomarker that differentiate septic arthritis and Juvenile
      Idiopathic Arthritis in children. Synovial liquid and blood samples with proteomic, MiRNA
      searching, multiplex cytokine analysis and cellular phenotyping, will be analysed. The
      results for each data will be compared in function of the disease to search discriminant
      markers. On behalf with this result specific pathways could be identified .
This a multicentric prospective study that compares biological fluids as synovial liquid and
      blood samples to find biomarkers that could distinguish septic arthritis and juvenile
      idiopathic arthritis. Prospectively, patients will be recruited under the age of 15 who are
      in care for septic or inflammatory arthritis at the University Hospitals of Montpellier,
      Lyon, Nimes and Toulouse. Patients should have an indication of blood and synovial as part of
      their management :

      Group A: acute juvenile arthritis with suspicion of bacterial infection, , confirmed on a
      bacteriological plan, either by culture of the articular liquid or by blood culture, or by
      molecular biology in the articular liquid.

      Group B: Idiopathic juvenile arthritis and control topics (Group C). In this project, the aim
      is to analyze all in all 50 articular liquids and serum of inflammatory arthritises (Group
      B), and 30 articular liquids and serum of infectious confirmed arthritises (Group A) which
      will require the inclusion about 50 possibly septic arthritis. The diagnosis of infectious
      arthritis is not immediate, he(it) is confirmed at the latest three weeks after the draining.
      So a group of control will be constituted.

      Group C: the blood of 20 healthy children matched by the age and at the sex in the groups A
      and B will be collected to analyze elements studied in the blood.

        -  Inclusion criteria :

      Group A and group B:

        -  Subject of more than 6 months and under age 15 years,

        -  Presenting acute arthritis taken care in the University Hospitals of Montpellier, Nimes,
           Toulouse or Lyon, and requiring an articular puncture

        -  Child benefiting from a social security system,

        -  Collection of the consent of the legal parents/representatives,

      Group C:

        -  Subject of more than 6 months and under age 15 include

        -  Taken care in the University Hospital of Montpellier, and requiring a venous draining,

        -  Child benefiting from a social security system,

        -  Collection of the consent of the legal parents/representatives

             -  Non inclusion criteria /

      Group A and group B:

        -  Contraindication in an articular draining: platelet 50 000/mm3, pathologic hemostasis

        -  Treatment by biological therapy, corticoids or other immunosuppressant treatment in the
           month preceding the articular draining,

        -  antibiotic begun more than 24 hours before the inclusion.

      Group C: ·

        -  Patient achieves of an inflammatory chronic pathology

        -  Patient having presented an infectious episode in the previous 8 days -Patients under
           immunosuppressor or anti-infective

      Methods of measure of assessment criteria

      Analysis will be done on blood samples and synovial liquid, that remains after sample
      collected for the management of their disease. The blood test and an synovial liquid draining
      will be realized at the subject. Before freezing, aliquots will be realized so that every
      analysis can benefit from a minimum volume:

        -  Cellular analyses: will be only made in Montpellier and established by the set of
           collected cells (no necessary volume).

        -  Proteomic, MiRNA analysis and cytokine dosing will been done in the second time.

      Statistical analysis will be done to individualize biomarkers.
observational model: Cohort
time perspective: Prospective
measure: Qualitative analysis of new biological markers (proteic) that discriminate inflammatory and infectious arthritis
time frame: 1 day
description: Identify blood sampling proteic markers of Arthritis childhood
measure: Qualitative analysis of new biological markers (cytokine) that discriminate inflammatory and infectious arthritis
time frame: 1 day
description: Identify blood sampling markers (cytokine : interleukin 2, interleukin 4, interleukin 6, interleukin 7, tumor necrosis factor alpha (TNF)) of Arthritis childhood
measure: Qualitative analysis of new cellular markers that discriminate inflammatory and infectious arthritis
time frame: 1 day
description: Identify blood sampling cellular markers (lymphocytes and monocytes) of Arthritis childhood
measure: Qualitative analysis of inflammatory process markers
time frame: 1 day
description: Identify articular liquid sampling biomarkers (lymphocytes and interleukins) of Arthritis childhood
arm group label: septic arthritis (group A)
description: Patients with acute juvenile arthritis with suspicion of bacterial infection,confirmed on a bacteriological plan, either by culture of the articular liquid or by blood culture, or by molecular biology in the articular liquid;
arm group label: inflammatory arthritis (group B)
description: Patients with idiopathic juvenile arthritis
arm group label: control (group C)
description: Healthy children who are matched by the age and at the sex in the groups A and B, to analyze elements studied in the blood.
Synovial liquid and blood samples (with : proteomic, MiRNA searching, multiplex cytokine
      analysis and cellular phenotyping) will be analysed.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric JEZIORSKI, MD PhD
role: Study Director
affiliation: University Hospital, Montpellier
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Arthritis, Infectious
mesh term: Arthritis