<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/NCT04409392</url>
  </required_header>
  <id_info>
    <org_study_id>20-202</org_study_id>
    <nct_id>NCT04409392</nct_id>
  </id_info>
  <brief_title>Staphylococcus Lugdunensis Prosthetic Joint Infection</brief_title>
  <official_title>Staphylococcus Lugdunensis Prosthetic Joint Infection: a Retrospective Cohort Study</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>
      Staphylococcus lugdunensis is a coagulase-negative staphylococcus belonging to the human&#xD;
      commensal cutaneous flora, and has been little studied in the field of prosthetic joint&#xD;
      infections. However, it shares many virulence traits with Staphylococcus aureus, including&#xD;
      many adhesins and its ability to form biofilm, and the few series of cases reports a&#xD;
      significant failure rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Actual">April 1, 2021</completion_date>
  <primary_completion_date type="Actual">April 1, 2021</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of PJI infection with Staphylococcus lugdunensis</measure>
    <time_frame>between 2010 and 2020</time_frame>
    <description>proportion of patients having PJI infection with Staphylococcus lugdunensis, alone or with other bacteria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Description of PJI infection with Staphylococcus lugdunensis : type</measure>
    <time_frame>Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption</time_frame>
    <description>type of PJI : knee or hip prosthesis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Description of PJI infection with Staphylococcus lugdunensis : evolution</measure>
    <time_frame>Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption</time_frame>
    <description>evolution of PJI :evolution between prosthesis placement and the onset of symptoms, gateway to infection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Description of patients with PJI infection due to Staphylococcus lugdunensis</measure>
    <time_frame>Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption</time_frame>
    <description>type of patients: age, CMI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Description of patients with PJI infection due to Staphylococcus lugdunensis : follow up</measure>
    <time_frame>Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption</time_frame>
    <description>duration of the follow up of patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Description of patients with PJI infection due to Staphylococcus lugdunensis : medical treatment</measure>
    <time_frame>Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption</time_frame>
    <description>description and duration of antibiotics</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Description of patients with PJI infection due to Staphylococcus lugdunensis : surgical treatment</measure>
    <time_frame>Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption</time_frame>
    <description>description of surgery performed : DAIR, one-step exchange, two-step exchange</description>
  </primary_outcome>
  <primary_outcome>
    <measure>rate of treatment failure</measure>
    <time_frame>Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption</time_frame>
    <description>Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">84</enrollment>
  <condition>Staphylococcal Infections</condition>
  <condition>Prosthetic Joint Infection</condition>
  <arm_group>
    <arm_group_label>Prothestic joint infection due to Staphylococcus lugdunensis</arm_group_label>
    <description>Patients having had a prosthetic joint infection with Staphylococcus lugdunensis</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prothestic joint infection due to Staphylococcus lugdunensis</intervention_name>
    <description>description of prosthetic joint infection with Staphylococcus lugdunensis</description>
    <arm_group_label>Prothestic joint infection due to Staphylococcus lugdunensis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients having had IPA due to Staphylococcus lugdunensis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  infection of joint prosthesis (whatever its type) with Staphylococcus lugdunensis&#xD;
             defined by the positivity of at least 2 gold-standard samples (joint puncture,&#xD;
             intraoperative samples) with S. lugdunensis; OR&#xD;
&#xD;
          -  a single positive gold-standard sample or positive blood cultures AND formal clinical,&#xD;
             radiological, biological and / or pathological arguments in favor of an infection of&#xD;
             joint prosthesis AND absence of other pathogenic agent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.crioac-lyon.fr</url>
    <description>Related Info</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>June 15, 2021</last_update_submitted>
  <last_update_submitted_qc>June 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Staphylococcus lugdunensis</keyword>
  <keyword>Prosthetic Joint Infection</keyword>
  <keyword>biofilm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Arthritis, Infectious</mesh_term>
    <mesh_term>Staphylococcal Infections</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/NCT04409392
org study id: 20-202
nct id: NCT04409392
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Staphylococcus lugdunensis is a coagulase-negative staphylococcus belonging to the human
      commensal cutaneous flora, and has been little studied in the field of prosthetic joint
      infections. However, it shares many virulence traits with Staphylococcus aureus, including
      many adhesins and its ability to form biofilm, and the few series of cases reports a
      significant failure rate.
observational model: Cohort
time perspective: Retrospective
measure: Rate of PJI infection with Staphylococcus lugdunensis
time frame: between 2010 and 2020
description: proportion of patients having PJI infection with Staphylococcus lugdunensis, alone or with other bacteria
measure: Description of PJI infection with Staphylococcus lugdunensis : type
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
description: type of PJI : knee or hip prosthesis
measure: Description of PJI infection with Staphylococcus lugdunensis : evolution
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
description: evolution of PJI :evolution between prosthesis placement and the onset of symptoms, gateway to infection
measure: Description of patients with PJI infection due to Staphylococcus lugdunensis
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
description: type of patients: age, CMI
measure: Description of patients with PJI infection due to Staphylococcus lugdunensis : follow up
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
description: duration of the follow up of patients
measure: Description of patients with PJI infection due to Staphylococcus lugdunensis : medical treatment
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
description: description and duration of antibiotics
measure: Description of patients with PJI infection due to Staphylococcus lugdunensis : surgical treatment
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
description: description of surgery performed : DAIR, one-step exchange, two-step exchange
measure: rate of treatment failure
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
description: Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin
arm group label: Prothestic joint infection due to Staphylococcus lugdunensis
description: Patients having had a prosthetic joint infection with Staphylococcus lugdunensis
intervention type: Other
intervention name: Prothestic joint infection due to Staphylococcus lugdunensis
description: description of prosthetic joint infection with Staphylococcus lugdunensis
arm group label: Prothestic joint infection due to Staphylococcus lugdunensis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
url: http://www.crioac-lyon.fr
description: Related Info
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Arthritis, Infectious
mesh term: Staphylococcal Infections
sharing ipd: Undecided