<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/NCT04460144</url>
  </required_header>
  <id_info>
    <org_study_id>APHP190930</org_study_id>
    <secondary_id>IDRCB 2019-A02427-50</secondary_id>
    <nct_id>NCT04460144</nct_id>
  </id_info>
  <brief_title>Rapid Diagnostic Test for Septic Arthritis</brief_title>
  <acronym>TDR-Arthrite</acronym>
  <official_title>Diagnostic Validation Study of a Test Based on the Analysis of the Proteome by Mass Spectrometry for the Diagnosis of Septic Arthritis in Children Under 16 Years of Age.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      Diagnostic Validation Study of a Test Based on the Analysis of the Proteome by Mass&#xD;
      Spectrometry for the Diagnosis of Septic Arthritis in Children Under 16 Years of Age&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Arthritis is an inflammation of the joints that can have many causes. In children, septic&#xD;
      arthritis (SA) is the most common cause of acute arthritis (around 45% of cases). Juvenile&#xD;
      Idiopathic Arthritis (JIA) is a disease characterized the presence of arthritis in one or&#xD;
      more of unknown origin in children under 16 years of age, lasting more than 6 weeks. It is&#xD;
      the most common pediatric rheumatological disease with a prevalence of 16 to 150 cases per&#xD;
      100,000 children. Finally, in approximately 40% of children the origin of acute arthritis&#xD;
      remains undetermined (ND arthritis). In this group, all the examinations performed are not in&#xD;
      favor of a bacterial origin and the evolution of arthritis do not allow the diagnosis of JIA&#xD;
      to be retained and no other disease is found.&#xD;
&#xD;
      During the first few days of arthritis, differentiation between AS and non-septic arthritis&#xD;
      is difficult. The available clinical and biological parameters do not allow for easy and&#xD;
      rapid differentiation between AS and non-septic arthritis.&#xD;
&#xD;
      This project aims to develop a new diagnostic technique based on molecular analysis of the&#xD;
      proteome in the joint puncture fluid.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 6, 2021</start_date>
  <completion_date type="Actual">December 6, 2022</completion_date>
  <primary_completion_date type="Actual">October 21, 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>Mass spectrometry profile</measure>
    <time_frame>15 months</time_frame>
    <description>Proteomics</description>
  </primary_outcome>
  <enrollment type="Actual">274</enrollment>
  <condition>Juvenile Idiopathic Arthritis</condition>
  <condition>Arthritis, Septic</condition>
  <condition>Arthritis, Unspecified</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Mass spectrometry</intervention_name>
    <description>Proteomic analysis</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      synovial fluid blood sample stool sample nasal swab&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute arthritis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt;3 months of age &lt;16 years of age&#xD;
&#xD;
          -  Hospitalized for arthritis that started less than 6 weeks ago or patients with&#xD;
             diagnosed inflammatory arthritis whose clinical course suggests bacterial&#xD;
             superinfection&#xD;
&#xD;
          -  Indication of a joint puncture for diagnostic purposes, confirmed by a senior&#xD;
             physician after study of all available clinical and biological elements.&#xD;
&#xD;
          -  Holders of parental authority who have accepted the participation of their children&#xD;
&#xD;
          -  Patients benefiting from a social security scheme (excluding AME)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to joint puncture&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulrich MEINZER, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephane BONACORSI, MD-PhD</last_name>
    <role>Study Director</role>
    <affiliation>APHP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Robert Debre Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2023</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>Arthritis, Infectious</mesh_term>
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Juvenile</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04460144
org study id: APHP190930
secondary id: IDRCB 2019-A02427-50
nct id: NCT04460144
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diagnostic Validation Study of a Test Based on the Analysis of the Proteome by Mass
      Spectrometry for the Diagnosis of Septic Arthritis in Children Under 16 Years of Age
Arthritis is an inflammation of the joints that can have many causes. In children, septic
      arthritis (SA) is the most common cause of acute arthritis (around 45% of cases). Juvenile
      Idiopathic Arthritis (JIA) is a disease characterized the presence of arthritis in one or
      more of unknown origin in children under 16 years of age, lasting more than 6 weeks. It is
      the most common pediatric rheumatological disease with a prevalence of 16 to 150 cases per
      100,000 children. Finally, in approximately 40% of children the origin of acute arthritis
      remains undetermined (ND arthritis). In this group, all the examinations performed are not in
      favor of a bacterial origin and the evolution of arthritis do not allow the diagnosis of JIA
      to be retained and no other disease is found.

      During the first few days of arthritis, differentiation between AS and non-septic arthritis
      is difficult. The available clinical and biological parameters do not allow for easy and
      rapid differentiation between AS and non-septic arthritis.

      This project aims to develop a new diagnostic technique based on molecular analysis of the
      proteome in the joint puncture fluid.
observational model: Cohort
time perspective: Prospective
measure: Mass spectrometry profile
time frame: 15 months
description: Proteomics
intervention type: Diagnostic Test
intervention name: Mass spectrometry
description: Proteomic analysis
synovial fluid blood sample stool sample nasal swab
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Months
maximum age: 16 Years
healthy volunteers: No
last name: Ulrich MEINZER, MD-PhD
role: Principal Investigator
affiliation: APHP
last name: Stephane BONACORSI, MD-PhD
role: Study Director
affiliation: APHP
facility: 
country: France
responsible party type: Sponsor
mesh term: Arthritis, Infectious
mesh term: Arthritis
mesh term: Arthritis, Juvenile
sharing ipd: Undecided