<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/NCT03263832</url>
  </required_header>
  <id_info>
    <org_study_id>2015-A0022472</org_study_id>
    <nct_id>NCT03263832</nct_id>
  </id_info>
  <brief_title>Evaluation of the Antibiofilmogramme Test During Orthopaedic Device-Related Infection</brief_title>
  <acronym>BJIBiofilm</acronym>
  <official_title>Demonstration of Clinical Value of Antibiofilmogramme Test for Monomicrobial S. Aureus Orthopaedic Device-Related Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioFilm Control</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>BioFilm Control</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>
      This is an observational study that does not change routine care.&#xD;
&#xD;
      The primary objective of this study is to investigate the correlation between the&#xD;
      administration of an antibiotherapy able to prevent biofilm formation according to the&#xD;
      results of the Antibiofilmogramme test, and the relapse of the infection for patient with&#xD;
      orthopaedic device-related infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The secondary objectives are:&#xD;
&#xD;
      A. Investigate the role of antibiogram-antibiofilmogramme concordance (in terms of S. aureus&#xD;
      strains and prescribed antibiotics) in orthopaedic device-related infection management.&#xD;
&#xD;
      B. Investigate the capacity of S. aureus isolates to form biofilm in presence/absence of&#xD;
      antibiotics.&#xD;
&#xD;
      C. Create an S. aureus strain collection for future ancillary studies&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 1, 2015</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Success or treatment failure</measure>
    <time_frame>From surgical intervention to one year after the end of antimicrobial therapy.</time_frame>
    <description>Presence or absence of microbiological treatment failure confirmed by S. aureus positive clinical samples. The diagnostic of a S. aureus positive clinical sample indicated a treatment failure. Treatment success corresponded to an absence of clinical or microbiological treatment failure, or treatment failure with positive clinical sample other than S. aureus.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Age</measure>
    <time_frame>Baseline (Day 0)</time_frame>
    <description>(years)</description>
  </other_outcome>
  <other_outcome>
    <measure>Sex</measure>
    <time_frame>Baseline (Day 0)</time_frame>
    <description>(m/f)</description>
  </other_outcome>
  <other_outcome>
    <measure>Body mass index</measure>
    <time_frame>Baseline (Day 0)</time_frame>
    <description>(kg/m²)</description>
  </other_outcome>
  <other_outcome>
    <measure>Charlson Comorbidity Index</measure>
    <time_frame>Baseline (Day 0)</time_frame>
    <description>(0-37)</description>
  </other_outcome>
  <other_outcome>
    <measure>Localization of the infection</measure>
    <time_frame>Baseline (Day 0)</time_frame>
    <description>Knee, Hip or other</description>
  </other_outcome>
  <other_outcome>
    <measure>Orthopaedic device</measure>
    <time_frame>Baseline (Day 0)</time_frame>
    <description>Prothesis, screw, plate or other</description>
  </other_outcome>
  <other_outcome>
    <measure>Time of onset of symptoms</measure>
    <time_frame>Baseline (Day 0)</time_frame>
    <description>(date)</description>
  </other_outcome>
  <other_outcome>
    <measure>Time of microbiological diagnostics</measure>
    <time_frame>Baseline (Day 0)</time_frame>
    <description>(date)</description>
  </other_outcome>
  <other_outcome>
    <measure>Time of implantation of the device</measure>
    <time_frame>Baseline (Day 0)</time_frame>
    <description>(date)</description>
  </other_outcome>
  <other_outcome>
    <measure>Microbiological analysis</measure>
    <time_frame>Baseline (Day 0)</time_frame>
    <description>Number of positive S. aureus biopsy samples</description>
  </other_outcome>
  <other_outcome>
    <measure>Antibiogram results</measure>
    <time_frame>Baseline (Day 0)</time_frame>
    <description>Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance and MIC estimation by the Vitek</description>
  </other_outcome>
  <other_outcome>
    <measure>Surgical Therapy</measure>
    <time_frame>Baseline (Day 0)</time_frame>
    <description>Conservative treatment (arthrotomy, debriedment, synovectomy) or removal of implant (one stage, two stage)</description>
  </other_outcome>
  <other_outcome>
    <measure>Antibiotics taken</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Name of the molecule, dose and duration</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">45</enrollment>
  <condition>Prosthetic Joint Infection</condition>
  <condition>Staphylococcus Aureus</condition>
  <condition>Biofilm</condition>
  <arm_group>
    <arm_group_label>Exposed</arm_group_label>
    <description>Patients with a monomicrobial S. aureus orhtopaedic device-related infection who have received antibiotherapy able to prevent biofilm formation following surgical intervention (from day 0 to day 7).&#xD;
Upon inclusion, antibiograms were performed on the S. aureus isolated as part of routine procedure. S. aureus isolates was further analysed via an Antibiofilmogramme, which is an experimental element added by this research.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Not Exposed</arm_group_label>
    <description>Patients with a monomicrobial S. aureus orhtopaedic device-related infection who not have received antibiotherapy able to prevent biofilm formation following surgical intervention (from day 0 to day 7).&#xD;
Upon inclusion, antibiograms were performed on the S. aureus isolated as part of routine procedure. S. aureus isolates was further analysed via an Antibiofilmogramme, which is an experimental element added by this research.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Antibiofilmogramme</intervention_name>
    <description>An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.</description>
    <arm_group_label>Exposed</arm_group_label>
    <arm_group_label>Not Exposed</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The S. aureus strains isolated will be maintained in a collection for future ancillary&#xD;
      studies.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population is composed of patient with a monomicrobial S. aureus orthopaedic&#xD;
        device-related infections.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient must have been informed and received a non-opposition consent form&#xD;
&#xD;
          -  Patient with a monomicrobial S. aureus bone and joint infections&#xD;
&#xD;
          -  Patient with prosthetic or orthopaedic device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bone and joint infection from pressure ulcer, vascular injury or diabetic foot ulcer&#xD;
&#xD;
          -  Polymicrobial prosthetic joint infection&#xD;
&#xD;
          -  The patient is participating in, or has participated in within the past 3 months,&#xD;
             another interventional study, or is currently in an exclusion period determined by a&#xD;
             preceding study&#xD;
&#xD;
          -  Patient is under judicial protection, under tutorship or curatorship&#xD;
&#xD;
          -  The patient expresses his opposition to participate to the study&#xD;
&#xD;
          -  It is impossible to correctly inform the patient&#xD;
&#xD;
          -  The patient is pregnant, parturient or breastfeeding&#xD;
&#xD;
          -  Emergency situation precluding correct study implementation&#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>Frederic Laurent, PharmD - PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</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>March 2021</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>March 1, 2021</last_update_submitted>
  <last_update_submitted_qc>March 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Antibiogramme</keyword>
  <keyword>Antibiofilmogramme</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>Prosthesis-Related Infections</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/NCT03263832
org study id: 2015-A0022472
nct id: NCT03263832
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an observational study that does not change routine care.

      The primary objective of this study is to investigate the correlation between the
      administration of an antibiotherapy able to prevent biofilm formation according to the
      results of the Antibiofilmogramme test, and the relapse of the infection for patient with
      orthopaedic device-related infection.
The secondary objectives are:

      A. Investigate the role of antibiogram-antibiofilmogramme concordance (in terms of S. aureus
      strains and prescribed antibiotics) in orthopaedic device-related infection management.

      B. Investigate the capacity of S. aureus isolates to form biofilm in presence/absence of
      antibiotics.

      C. Create an S. aureus strain collection for future ancillary studies
observational model: Case-Control
time perspective: Prospective
measure: Success or treatment failure
time frame: From surgical intervention to one year after the end of antimicrobial therapy.
description: Presence or absence of microbiological treatment failure confirmed by S. aureus positive clinical samples. The diagnostic of a S. aureus positive clinical sample indicated a treatment failure. Treatment success corresponded to an absence of clinical or microbiological treatment failure, or treatment failure with positive clinical sample other than S. aureus.
measure: Age
time frame: Baseline (Day 0)
description: (years)
measure: Sex
time frame: Baseline (Day 0)
description: (m/f)
measure: Body mass index
time frame: Baseline (Day 0)
description: (kg/m²)
measure: Charlson Comorbidity Index
time frame: Baseline (Day 0)
description: (0-37)
measure: Localization of the infection
time frame: Baseline (Day 0)
description: Knee, Hip or other
measure: Orthopaedic device
time frame: Baseline (Day 0)
description: Prothesis, screw, plate or other
measure: Time of onset of symptoms
time frame: Baseline (Day 0)
description: (date)
measure: Time of microbiological diagnostics
time frame: Baseline (Day 0)
description: (date)
measure: Time of implantation of the device
time frame: Baseline (Day 0)
description: (date)
measure: Microbiological analysis
time frame: Baseline (Day 0)
description: Number of positive S. aureus biopsy samples
measure: Antibiogram results
time frame: Baseline (Day 0)
description: Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance and MIC estimation by the Vitek
measure: Surgical Therapy
time frame: Baseline (Day 0)
description: Conservative treatment (arthrotomy, debriedment, synovectomy) or removal of implant (one stage, two stage)
measure: Antibiotics taken
time frame: through study completion, an average of 1 year
description: Name of the molecule, dose and duration
arm group label: Exposed
description: Patients with a monomicrobial S. aureus orhtopaedic device-related infection who have received antibiotherapy able to prevent biofilm formation following surgical intervention (from day 0 to day 7).
Upon inclusion, antibiograms were performed on the S. aureus isolated as part of routine procedure. S. aureus isolates was further analysed via an Antibiofilmogramme, which is an experimental element added by this research.
arm group label: Not Exposed
description: Patients with a monomicrobial S. aureus orhtopaedic device-related infection who not have received antibiotherapy able to prevent biofilm formation following surgical intervention (from day 0 to day 7).
Upon inclusion, antibiograms were performed on the S. aureus isolated as part of routine procedure. S. aureus isolates was further analysed via an Antibiofilmogramme, which is an experimental element added by this research.
intervention type: Diagnostic Test
intervention name: Antibiofilmogramme
description: An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.
arm group label: Exposed
arm group label: Not Exposed
The S. aureus strains isolated will be maintained in a collection for future ancillary
      studies.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Frederic Laurent, PharmD - PhD
role: Principal Investigator
affiliation: Hospices Civils de Lyon
facility: 
country: France
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Prosthesis-Related Infections