<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/NCT04409769</url>
  </required_header>
  <id_info>
    <org_study_id>20-157</org_study_id>
    <nct_id>NCT04409769</nct_id>
  </id_info>
  <brief_title>Evaluation of the Tolerance of Ceftaroline and Ceftobiprole in the Management of BJI / PJI</brief_title>
  <official_title>Evaluation of the Tolerance of Anti-MRSA Betalactamines (Ceftaroline / Ceftobiprole) in the Management of BJI / PJI: a Retrospective Study in a Reference Center</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>
      Staphyloccous aureus and coagulase negative staphylocci are responsible of a large marjority&#xD;
      of PJI. Regarding the high rate of methicillin resistance, current guidelines recommend the&#xD;
      use of a glycopeptide, and most frequently vancomycin, as the anti-gram positive agent in&#xD;
      empirical therapy, while awaiting the microbiological results. Vancomycin is not considered&#xD;
      as a safe antibiotic, and daptomycin is frequently an alternative option.&#xD;
&#xD;
      Ceftaroline and ceftobiprole are the only betalactam active on methicillin-resistant&#xD;
      staphylococci. As some data report a synergistic activity with daptomycin, they could be an&#xD;
      option in pandrug-resistant staphylococci BJI, but their use if off label in this indication.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Actual">May 5, 2020</completion_date>
  <primary_completion_date type="Actual">May 5, 2020</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>Evaluation of use of ceftaroline and ceftobiprole : patients</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>Evaluation of use of ceftaroline: dosage</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>dosage,duration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of use of ceftaroline : PJI/BJI</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 the PJI/BJI treated by ceftaroline : presence of knee or hip prosthesis, evolution between prosthesis placement and the onset of symptoms, gateway to infection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of use of ceftobiprole: dosage</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>dosage, duration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of use of ceftobiprole: PJI/BJI</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 the PJI/BJI treated by ceftobiprole : presence of knee or hip prosthesis, evolution between prosthesis placement and the onset of symptoms, gateway to infection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>rate of failure under ceftaroline</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>
  <primary_outcome>
    <measure>rate of failure under ceftobiprole</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>
  <secondary_outcome>
    <measure>Treatment-related adverse events</measure>
    <time_frame>2 months</time_frame>
    <description>description of adverse event under ceftaroline and/or ceftobiprole as assessed by CTCAE v4.0</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">22</enrollment>
  <condition>Bone and Joint Infection</condition>
  <condition>Antibiotic Reaction</condition>
  <arm_group>
    <arm_group_label>Description of use of ceftaroline and ceftobiprole</arm_group_label>
    <description>description of patients and their PJI/BJI,conditions of use, adverse event</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Description of use of ceftaroline and ceftobiprole</intervention_name>
    <description>Ceftaroline and ceftobiprole are the only betalactam active on methicillin-resistant staphylococci. Description of condition of use of thoses antibiotics in PJI and BJI</description>
    <arm_group_label>Description of use of ceftaroline and ceftobiprole</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients having had a PJI or BJI treated whith ceftaroline and/or ceftobiprole treated at&#xD;
        CRIOAc Lyon&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients having had a PJI or BJI treated whith ceftaroline and/or ceftobiprole&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </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>June 2020</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bone and joint infection</keyword>
  <keyword>prosthesis joint infection</keyword>
  <keyword>adverse event</keyword>
  <keyword>ceftaroline</keyword>
  <keyword>ceftobiprole</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ceftaroline fosamil</mesh_term>
    <mesh_term>Ceftobiprole</mesh_term>
    <mesh_term>Ceftobiprole medocaril</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/NCT04409769
org study id: 20-157
nct id: NCT04409769
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Staphyloccous aureus and coagulase negative staphylocci are responsible of a large marjority
      of PJI. Regarding the high rate of methicillin resistance, current guidelines recommend the
      use of a glycopeptide, and most frequently vancomycin, as the anti-gram positive agent in
      empirical therapy, while awaiting the microbiological results. Vancomycin is not considered
      as a safe antibiotic, and daptomycin is frequently an alternative option.

      Ceftaroline and ceftobiprole are the only betalactam active on methicillin-resistant
      staphylococci. As some data report a synergistic activity with daptomycin, they could be an
      option in pandrug-resistant staphylococci BJI, but their use if off label in this indication.
observational model: Cohort
time perspective: Retrospective
measure: Evaluation of use of ceftaroline and ceftobiprole : patients
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: Evaluation of use of ceftaroline: dosage
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
description: dosage,duration
measure: Evaluation of use of ceftaroline : PJI/BJI
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
description: description of the PJI/BJI treated by ceftaroline : presence of knee or hip prosthesis, evolution between prosthesis placement and the onset of symptoms, gateway to infection
measure: Evaluation of use of ceftobiprole: dosage
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
description: dosage, duration
measure: Evaluation of use of ceftobiprole: PJI/BJI
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
description: description of the PJI/BJI treated by ceftobiprole : presence of knee or hip prosthesis, evolution between prosthesis placement and the onset of symptoms, gateway to infection
measure: rate of failure under ceftaroline
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 failure under ceftobiprole
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: Treatment-related adverse events
time frame: 2 months
description: description of adverse event under ceftaroline and/or ceftobiprole as assessed by CTCAE v4.0
arm group label: Description of use of ceftaroline and ceftobiprole
description: description of patients and their PJI/BJI,conditions of use, adverse event
intervention type: Other
intervention name: Description of use of ceftaroline and ceftobiprole
description: Ceftaroline and ceftobiprole are the only betalactam active on methicillin-resistant staphylococci. Description of condition of use of thoses antibiotics in PJI and BJI
arm group label: Description of use of ceftaroline and ceftobiprole
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: France
url: http://www.crioac-lyon.fr
description: Related Info
responsible party type: Sponsor
mesh term: Infections
mesh term: Ceftaroline fosamil
mesh term: Ceftobiprole
mesh term: Ceftobiprole medocaril
sharing ipd: Undecided