<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/NCT03750721</url>
  </required_header>
  <id_info>
    <org_study_id>18-040</org_study_id>
    <nct_id>NCT03750721</nct_id>
  </id_info>
  <brief_title>Staphylococcal Acute Post-Operative PJI Treated With 'DAIR' And Impact Of Rifampin</brief_title>
  <acronym>IPASTAPH</acronym>
  <official_title>Staphylococcal Acute Post-Operative Prosthetic Joint Infection Treated With 'DAIR' (Debridement and Implant Retention) And Impact Of Rifampin: A Retrospective Cohort Study In France</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>
      S. aureus and coagulase-negative staphylococci are the most frequent bacteria responsible for&#xD;
      PJI (prosthetic joint infection). The aim of this study is to describe the use of rifampicin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">May 1, 2018</completion_date>
  <primary_completion_date type="Actual">May 1, 2018</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>description of the use of rifampicin : rate of use</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>the aim is to determine how the use of rifampin influence the prognosis in staphylococcal acute post-operative prosthetic joint infection treated with DAIR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>rate of failure for treatment using rifampin</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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of adverse event with rifampin</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 adverses events leading to stop the rifampicin</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">79</enrollment>
  <condition>Bone and Joint Infection</condition>
  <condition>Antibiotic Resistant Staphylococcus Aureus Infection</condition>
  <arm_group>
    <arm_group_label>Role of rifampin in staphylococcal PJI</arm_group_label>
    <description>retrospective cohort study in 4 hospitals : patients with staphylococcal acute post-operative (&lt; 1 month) PJI treated with DAIR in 2011-2016 period</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Role of rifampin in staphylococcal PJI</intervention_name>
    <description>the aim is to determine if the dose and the duration of rifampin influenced the prognosis</description>
    <arm_group_label>Role of rifampin in staphylococcal PJI</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        retrospective cohort study in 4 hospitals : patients with staphylococcal acute&#xD;
        post-operative (&lt; 1 month) PJI treated with DAIR in 2011-2016 period&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        patients having had acute PJI (i.e. &lt;1 month following the implantation), DAIR with&#xD;
        exchange of removal components) due to S. aureus and coagulase-negative staphylococci&#xD;
        (2011-2016)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Tristan FERRY, Md,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon Hôpital de la Croix-Rousse</affiliation>
  </overall_official>
  <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>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 7, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</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>
  <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>Staphylococcal Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rifampin</mesh_term>
  </intervention_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/NCT03750721
org study id: 18-040
nct id: NCT03750721
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
S. aureus and coagulase-negative staphylococci are the most frequent bacteria responsible for
      PJI (prosthetic joint infection). The aim of this study is to describe the use of rifampicin.
observational model: Cohort
time perspective: Retrospective
measure: description of the use of rifampicin : rate of use
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
description: the aim is to determine how the use of rifampin influence the prognosis in staphylococcal acute post-operative prosthetic joint infection treated with DAIR
measure: rate of failure for treatment using rifampin
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
measure: rate of adverse event with rifampin
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
description: Description of adverses events leading to stop the rifampicin
arm group label: Role of rifampin in staphylococcal PJI
description: retrospective cohort study in 4 hospitals : patients with staphylococcal acute post-operative (< 1 month) PJI treated with DAIR in 2011-2016 period
intervention type: Other
intervention name: Role of rifampin in staphylococcal PJI
description: the aim is to determine if the dose and the duration of rifampin influenced the prognosis
arm group label: Role of rifampin in staphylococcal PJI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
last name: Tristan FERRY, Md,PhD
role: Principal Investigator
affiliation: Hospices Civils de Lyon Hôpital de la Croix-Rousse
facility: 
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: Communicable Diseases
mesh term: Staphylococcal Infections
mesh term: Rifampin
sharing ipd: Undecided