<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/NCT03796104</url>
  </required_header>
  <id_info>
    <org_study_id>18-333</org_study_id>
    <nct_id>NCT03796104</nct_id>
  </id_info>
  <brief_title>Prognostic Impact of Delta-haemolysin Production Deficiency in Staphylococcus Aureus on the Prognosis of Infected Implant Treated by DAIR</brief_title>
  <official_title>Prognostic Impact of Delta-haemolysin Production Deficiency in Staphylococcus Aureus on the Prognosis of Infected Implant Treated by DAIR</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>
      The aim of this study is to determine if delta-haemolysin production deficiency of&#xD;
      Staphylococcus aureus is a marker in favour of chronic infections on implants&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of infection with or witout delta-haemolysin in Staphylococcus Aureus</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>patients, profile of the bacterium, medical and chirurgical treatment, rate. comparison between the 2 groups</description>
  </primary_outcome>
  <secondary_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. Analyse of risk factor. Comparison between the 2 groups</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Bone and Joint Infection</condition>
  <condition>Staphylococcus Aureus</condition>
  <arm_group>
    <arm_group_label>Deficiency of delta-hemolysine</arm_group_label>
    <description>Implant infected by Staphylococcus aureus with delta-haemolysin Production Deficiency</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Presence of delta-hemolysine</arm_group_label>
    <description>Implant infected by Staphylococcus aureus with delta-haemolysin Production</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Delta-haemolysin</intervention_name>
    <description>comparison of groups having infection with S. aureus with and without delta-haemolysin Production</description>
    <arm_group_label>Deficiency of delta-hemolysine</arm_group_label>
    <arm_group_label>Presence of delta-hemolysine</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients having implant infection due to S. aureus treated by DAIR managed at the Lyon Bone&#xD;
        and joint infection reference Center between 2006 and 2018&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients having implant infection due to S. aureus treated by DAIR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>FLORENT VALOUR, Md,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Johanna Boulant, CRA</last_name>
    <email>johanna.boulant@chu-lyon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eugenie Mabrut, CRA</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospices Civils de Lyon</investigator_affiliation>
    <investigator_full_name>Eugénie MABRUT</investigator_full_name>
    <investigator_title>clinical research assistant</investigator_title>
  </responsible_party>
  <keyword>Bone and Joint Infection</keyword>
  <keyword>Staphylococcus Aureus</keyword>
  <keyword>chronic infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</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/NCT03796104
org study id: 18-333
nct id: NCT03796104
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine if delta-haemolysin production deficiency of
      Staphylococcus aureus is a marker in favour of chronic infections on implants
observational model: Case-Control
time perspective: Prospective
measure: Rate of infection with or witout delta-haemolysin in Staphylococcus Aureus
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
description: patients, profile of the bacterium, medical and chirurgical treatment, rate. comparison between the 2 groups
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. Analyse of risk factor. Comparison between the 2 groups
arm group label: Deficiency of delta-hemolysine
description: Implant infected by Staphylococcus aureus with delta-haemolysin Production Deficiency
arm group label: Presence of delta-hemolysine
description: Implant infected by Staphylococcus aureus with delta-haemolysin Production
intervention type: Other
intervention name: Delta-haemolysin
description: comparison of groups having infection with S. aureus with and without delta-haemolysin Production
arm group label: Deficiency of delta-hemolysine
arm group label: Presence of delta-hemolysine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
last name: FLORENT VALOUR, Md,PhD
role: Principal Investigator
affiliation: Hospices Civils de Lyon
last name: Johanna Boulant, CRA
email: johanna.boulant@chu-lyon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hospices Civils de Lyon
investigator full name: Eugénie MABRUT
investigator title: clinical research assistant
mesh term: Infections
mesh term: Staphylococcal Infections
sharing ipd: Undecided