<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/NCT03819855</url>
  </required_header>
  <id_info>
    <org_study_id>35RC18_30015_SYNOLACTATES-PLUS</org_study_id>
    <nct_id>NCT03819855</nct_id>
  </id_info>
  <brief_title>External Validation of a Septic Arthritis Prognosis Score</brief_title>
  <acronym>SYNOLACTATES +</acronym>
  <official_title>External Validation of the RESAS (REnnes Septic Arthritis Score) Septic Arthritis Prognosis Score in an Acute Arthritis Cohort of Less Than 30 Days</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      Observational study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Septic arthritis is a diagnostic emergency for acute arthritis because it is accompanied by&#xD;
      an excess of mortality of 11% and frequent functional sequelae in about 50% of cases in the&#xD;
      year. However, it remains rare with an estimated annual incidence of 1 to 5/100000, and a&#xD;
      prevalence of about 10% in front of an acute arthritis table sent to an emergency department.&#xD;
&#xD;
      The diagnosis is based on the bacteriological culture which finds the presence of a&#xD;
      microorganism within the joint. However, only 80% of septic arthritis is bacteriologically&#xD;
      documented due to low inoculum, the presence of fragile bacteria (Neisseria sp) or especially&#xD;
      untimely antibiotherapy prior to joint puncture.&#xD;
&#xD;
      In addition, the bacteriological culture takes an average of 3 days to become positive, which&#xD;
      may delay the implementation of appropriate antibiotic therapy.&#xD;
&#xD;
      It is therefore essential that the clinician can rely on other clinical or biological&#xD;
      parameters, reliable and fast for better diagnostic orientation.&#xD;
&#xD;
      A first study: SYNOLACTATES showed the interest of the measurement of glucose and synovial&#xD;
      lactate for the diagnosis of septic arthritis with very good performances. A RESAS score&#xD;
      (REnnes Septic Arthritis Score) was constructed from these results to assess the likelihood&#xD;
      of septic arthritis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2019</start_date>
  <completion_date type="Actual">February 15, 2021</completion_date>
  <primary_completion_date type="Actual">February 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>RESAS (Rennes Septic Arthritis Score)</measure>
    <time_frame>Up to 3 days (time to collect laboratory results)</time_frame>
    <description>Composite score of 4 biological variables of the synovial liquid (macroscopically purulent liquid and/or Synovial White Cells Counts (SWCC) ≥ 75000/mm3, synovial crystal vizualization, synovial lactate dosage, synovial glucose dosage). Each variable is weighted as follows: macroscopically purulent liquid or SWCC ≥ 75000/mm3 (+3 points), UMS (-4 points) or CPP (-2 points) crystal Vizualization, lactate ≥ 11.5 mmol/L (+6 points) or 10-11.4 mmol/L (+4 points) or 8.5-9.9 mmol/L (+2 points), glucose ≤ 1.0 mmol/L (+4 points), 1.1-1.8 mmol/L (+2 points), yielding a total between -4 and 13.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Macroscopic synovial fluid appearance</measure>
    <time_frame>Up to 1 day (time to collect clinical parameters)</time_frame>
    <description>Expressed in multiple qualitative variable: purulent, trouble, clear citrine appearance, hemarthrosis or clear with blood threads</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microscopic synovial analysis</measure>
    <time_frame>Up to 3 days (time to collect laboratory results)</time_frame>
    <description>Presence of crystals in synovial fluid: urate monosodic (UMS) crystal (Yes or No), and calcium pyrophosphate crystal (CPP) (Yes or No)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Synovial White Cells Count (SWCC)</measure>
    <time_frame>Up to 3 days (time to collect laboratory results)</time_frame>
    <description>Number (n) of White cells in synovial fluid. (quantitative variable expressed in n/mm3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total lactates, D-lactate, glucose</measure>
    <time_frame>Up to 3 days (time to collect laboratory results)</time_frame>
    <description>Measures of total lactate, D-lactate et glucose in synovial fluid (quantitative variable expressed in mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Others synovial proteic markers</measure>
    <time_frame>Up to 3 days (time to collect laboratory results)</time_frame>
    <description>Measures of CRP (mg/L) in synovial fluid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Others synovial proteic markers</measure>
    <time_frame>Up to 3 days (time to collect laboratory results)</time_frame>
    <description>Measures of Procalcitonine (ng/mL) in synovial fluid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Others synovial proteic markers</measure>
    <time_frame>Up to 3 days (time to collect laboratory results)</time_frame>
    <description>Measures of Calprotectin (ng/mL) in synovial fluid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multielemental analysis by ICP-MS</measure>
    <time_frame>Up to 3 days (time to collect laboratory results)</time_frame>
    <description>Screening multielemental in synovial fluid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of classical clinical marker (quantitative variable) to diagnosis of septic arthritis</measure>
    <time_frame>Up to 1 day (time to collect clinical parameters)</time_frame>
    <description>Fever (expressed in Celcius degree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of classical clinical marker (quantitative variable) to diagnosis of septic arthritis</measure>
    <time_frame>Up to 1 day (time to collect clinical parameters)</time_frame>
    <description>Duration of symptoms (expressed in day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of classical clinical marker (qualitative variable) to diagnosis of septic arthritis</measure>
    <time_frame>Up to 1 day (time to collect clinical parameters)</time_frame>
    <description>Co-morbidity promoting infection (diabetes, cirrhosis, HIV, severe chronic renal failure, rheumatoid arthritis, other inflammatory rheumatic diseases, immunosuppressive treatments such as corticosteroids, conventional synthetic-DMARDs, biological-DMARDs) (Yes or No)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of classical clinical marker (qualitative variable) to diagnosis of septic arthritis</measure>
    <time_frame>Up to 1 day (time to collect clinical parameters)</time_frame>
    <description>Number of joints affected (Ordinal variable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parameters that may influence the bacteriological results of synovial fluid</measure>
    <time_frame>Up to 1 day (time to collect clinical parameters)</time_frame>
    <description>NSAIDs, corticosteroids, antibiotics within 15 days of joint puncture (qualitative variable: Yes or No)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospitalization potentially avoided by the early elimination of an arthritis diagnosis and their cost, from the point of view of illness insurance</measure>
    <time_frame>Date of hospitalization until 2 months of follow-up</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">244</enrollment>
  <condition>Arthritis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients performing joint puncture in routine care as part of a diagnostic assessment of&#xD;
        acute arthritis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any acute arthritis less than or equal to 30 days;&#xD;
&#xD;
          -  Achievement of a joint puncture in routine care as part of the diagnostic assessment&#xD;
             of this acute arthritis;&#xD;
&#xD;
          -  Affiliation to a social security scheme;&#xD;
&#xD;
          -  No one opposes his participation in the research.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age below 18 years;&#xD;
&#xD;
          -  Major persons subject to legal protection (safeguard of justice, guardianship,&#xD;
             guardianship), persons deprived of their liberty.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillaume Coiffier</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rennes University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rennes University Hospital</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2021</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>
  </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/NCT03819855
org study id: 35RC18_30015_SYNOLACTATES-PLUS
nct id: NCT03819855
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Observational study
Septic arthritis is a diagnostic emergency for acute arthritis because it is accompanied by
      an excess of mortality of 11% and frequent functional sequelae in about 50% of cases in the
      year. However, it remains rare with an estimated annual incidence of 1 to 5/100000, and a
      prevalence of about 10% in front of an acute arthritis table sent to an emergency department.

      The diagnosis is based on the bacteriological culture which finds the presence of a
      microorganism within the joint. However, only 80% of septic arthritis is bacteriologically
      documented due to low inoculum, the presence of fragile bacteria (Neisseria sp) or especially
      untimely antibiotherapy prior to joint puncture.

      In addition, the bacteriological culture takes an average of 3 days to become positive, which
      may delay the implementation of appropriate antibiotic therapy.

      It is therefore essential that the clinician can rely on other clinical or biological
      parameters, reliable and fast for better diagnostic orientation.

      A first study: SYNOLACTATES showed the interest of the measurement of glucose and synovial
      lactate for the diagnosis of septic arthritis with very good performances. A RESAS score
      (REnnes Septic Arthritis Score) was constructed from these results to assess the likelihood
      of septic arthritis.
observational model: Case-Only
time perspective: Prospective
measure: RESAS (Rennes Septic Arthritis Score)
time frame: Up to 3 days (time to collect laboratory results)
description: Composite score of 4 biological variables of the synovial liquid (macroscopically purulent liquid and/or Synovial White Cells Counts (SWCC) ≥ 75000/mm3, synovial crystal vizualization, synovial lactate dosage, synovial glucose dosage). Each variable is weighted as follows: macroscopically purulent liquid or SWCC ≥ 75000/mm3 (+3 points), UMS (-4 points) or CPP (-2 points) crystal Vizualization, lactate ≥ 11.5 mmol/L (+6 points) or 10-11.4 mmol/L (+4 points) or 8.5-9.9 mmol/L (+2 points), glucose ≤ 1.0 mmol/L (+4 points), 1.1-1.8 mmol/L (+2 points), yielding a total between -4 and 13.
measure: Macroscopic synovial fluid appearance
time frame: Up to 1 day (time to collect clinical parameters)
description: Expressed in multiple qualitative variable: purulent, trouble, clear citrine appearance, hemarthrosis or clear with blood threads
measure: Microscopic synovial analysis
time frame: Up to 3 days (time to collect laboratory results)
description: Presence of crystals in synovial fluid: urate monosodic (UMS) crystal (Yes or No), and calcium pyrophosphate crystal (CPP) (Yes or No)
measure: Synovial White Cells Count (SWCC)
time frame: Up to 3 days (time to collect laboratory results)
description: Number (n) of White cells in synovial fluid. (quantitative variable expressed in n/mm3)
measure: Total lactates, D-lactate, glucose
time frame: Up to 3 days (time to collect laboratory results)
description: Measures of total lactate, D-lactate et glucose in synovial fluid (quantitative variable expressed in mmol/L)
measure: Others synovial proteic markers
time frame: Up to 3 days (time to collect laboratory results)
description: Measures of CRP (mg/L) in synovial fluid
measure: Others synovial proteic markers
time frame: Up to 3 days (time to collect laboratory results)
description: Measures of Procalcitonine (ng/mL) in synovial fluid
measure: Others synovial proteic markers
time frame: Up to 3 days (time to collect laboratory results)
description: Measures of Calprotectin (ng/mL) in synovial fluid
measure: Multielemental analysis by ICP-MS
time frame: Up to 3 days (time to collect laboratory results)
description: Screening multielemental in synovial fluid
measure: Number of classical clinical marker (quantitative variable) to diagnosis of septic arthritis
time frame: Up to 1 day (time to collect clinical parameters)
description: Fever (expressed in Celcius degree)
measure: Number of classical clinical marker (quantitative variable) to diagnosis of septic arthritis
time frame: Up to 1 day (time to collect clinical parameters)
description: Duration of symptoms (expressed in day)
measure: Number of classical clinical marker (qualitative variable) to diagnosis of septic arthritis
time frame: Up to 1 day (time to collect clinical parameters)
description: Co-morbidity promoting infection (diabetes, cirrhosis, HIV, severe chronic renal failure, rheumatoid arthritis, other inflammatory rheumatic diseases, immunosuppressive treatments such as corticosteroids, conventional synthetic-DMARDs, biological-DMARDs) (Yes or No)
measure: Number of classical clinical marker (qualitative variable) to diagnosis of septic arthritis
time frame: Up to 1 day (time to collect clinical parameters)
description: Number of joints affected (Ordinal variable)
measure: Parameters that may influence the bacteriological results of synovial fluid
time frame: Up to 1 day (time to collect clinical parameters)
description: NSAIDs, corticosteroids, antibiotics within 15 days of joint puncture (qualitative variable: Yes or No)
measure: Number of hospitalization potentially avoided by the early elimination of an arthritis diagnosis and their cost, from the point of view of illness insurance
time frame: Date of hospitalization until 2 months of follow-up
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guillaume Coiffier
role: Principal Investigator
affiliation: Rennes University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Arthritis, Infectious
mesh term: Arthritis