<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/NCT02222792</url>
  </required_header>
  <id_info>
    <org_study_id>BJI 2</org_study_id>
    <nct_id>NCT02222792</nct_id>
  </id_info>
  <brief_title>BJI Inoplex 2 : Test for Diagnosis of Prosthetic Infections</brief_title>
  <official_title>Evaluation of the BJI Inoplex 2 Kit for the Multiplex Serological Diagnosis of Bone and Joint Prosthetic Device Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Diaxonhit</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Diaxonhit</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A national, prospective, open-label, non-interventional, multicentre, controlled study&#xD;
      designed to evaluate a diagnostic method in patients undergoing hip, knee or shoulder&#xD;
      prosthetic removal regardless of whether or not infection is suspected. Serological test&#xD;
      results will have no impact on the therapeutic approach.&#xD;
&#xD;
      Study objective: To evaluate the diagnostic performance of an antibody detection kit for the&#xD;
      serological diagnosis of bone and joint prosthetic device infections cause by Staphylococci,&#xD;
      Streptococci, Propionibacterium acnes (P. acnes) and Gram-negative bacteria versus the&#xD;
      reference method: the bacterial culture of deep intraoperative samples.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">July 2016</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity and specificity of test BJI 2</measure>
    <time_frame>2 years</time_frame>
    <description>The diagnostic performance of the test during unique titration.&#xD;
Sensitivity: estimated from the proportion of septic group patients with an antibody level above the defined threshold antibody concentration.&#xD;
Specificity: estimated from the proportion of non-septic-group patients with an antibody level less than or equal to the defined threshold antibody concentration.&#xD;
Positive likelihood ratio.&#xD;
Negative likelihood ratio.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Interest of test BJI 2</measure>
    <time_frame>2 years</time_frame>
    <description>To evaluate the diagnostic interest of the BJI Inoplex 2 test in conjunction with the clinical and laboratory data collected: diagnostic strategy and score combining several criteria.&#xD;
To evaluate the potential medical and economic benefits of using the test: number and cost of joint aspirations or hospital stays that would have been avoided, delayed diagnosis.&#xD;
To describe the serological outcome after surgery in septic patients.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">540</enrollment>
  <condition>Bone and Joint Prosthetic Infections</condition>
  <arm_group>
    <arm_group_label>Septic patient group</arm_group_label>
    <description>The septic patient group will be comprised of patients presenting with bone and joint prosthetic device infection confirmed by intraoperative microbiological culture (at least 2 deep positive samples for the same bacterial strain).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-septic patient group</arm_group_label>
    <description>The non-septic patient group will be comprised of prosthetic patients presenting with symptoms of mechanical loosening, and whose deep intraoperative samples have all proved negative</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intermediate group</arm_group_label>
    <description>An intermediate group will be comprised of patients with only one deep positive sample.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serologic assays of sera collected from septic or non-septic patients will be performed in&#xD;
      series and operators will be blind in terms of clinical and microbiological status in order&#xD;
      to avoid any interpretation bias due to information collected in advance&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The septic patient group will be comprised of patients presenting with bone and joint&#xD;
        prosthetic device infection confirmed by intraoperative microbiological culture (at least 2&#xD;
        deep positive samples for the same bacterial strain).&#xD;
&#xD;
        The non-septic patient group will be comprised of prosthetic patients presenting with&#xD;
        symptoms of mechanical loosening, and whose deep intraoperative samples have all proved&#xD;
        negative.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients&#xD;
&#xD;
          2. Patients 18 years of age or older&#xD;
&#xD;
          3. Patient with a bone and joint prosthetic device: total hip prosthesis (THP) or total&#xD;
             knee prosthesis (TKP) or total shoulder prosthesis (TSP)&#xD;
&#xD;
          4. Patients with a revision of a failed prosthesis, regardless of the cause and whether&#xD;
             septic or not&#xD;
&#xD;
          5. Patients who have not expressed their opposition to the use of their personal medical&#xD;
             data and blood samples&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients already enrolled or clinically reviewed following a relapse&#xD;
&#xD;
          2. Patients with several prostheses requiring at least two revisions during the same&#xD;
             surgical procedure&#xD;
&#xD;
          3. Patients for whom the microbiologist and/or doctor responsible for the care refuses&#xD;
             that these patients participate in the study&#xD;
&#xD;
          4. HIV+ patients&#xD;
&#xD;
          5. Patients undergoing chemotherapy for a blood disease or solid tumour&#xD;
&#xD;
          6. Patients under guardianship or trusteeship&#xD;
&#xD;
          7. Patients who are expected to be difficult to monitor (life expectancy less than 1&#xD;
             year, or homeless people, foreigner in transit)&#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>Hôpital Ambroise Paré</name>
      <address>
        <city>Boulogne-Billancourt</city>
        <zip>92100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe hospitalier Diaconesses Croix Saint Simon</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>August 20, 2014</last_update_submitted>
  <last_update_submitted_qc>August 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Staphylococci, Streptococci, P acnes and Gram-negative bacteria</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>
  </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/NCT02222792
org study id: BJI 2
nct id: NCT02222792
lead sponsor: 
has dmc: No
A national, prospective, open-label, non-interventional, multicentre, controlled study
      designed to evaluate a diagnostic method in patients undergoing hip, knee or shoulder
      prosthetic removal regardless of whether or not infection is suspected. Serological test
      results will have no impact on the therapeutic approach.

      Study objective: To evaluate the diagnostic performance of an antibody detection kit for the
      serological diagnosis of bone and joint prosthetic device infections cause by Staphylococci,
      Streptococci, Propionibacterium acnes (P. acnes) and Gram-negative bacteria versus the
      reference method: the bacterial culture of deep intraoperative samples.
time perspective: Prospective
measure: Sensitivity and specificity of test BJI 2
time frame: 2 years
description: The diagnostic performance of the test during unique titration.
Sensitivity: estimated from the proportion of septic group patients with an antibody level above the defined threshold antibody concentration.
Specificity: estimated from the proportion of non-septic-group patients with an antibody level less than or equal to the defined threshold antibody concentration.
Positive likelihood ratio.
Negative likelihood ratio.
measure: Interest of test BJI 2
time frame: 2 years
description: To evaluate the diagnostic interest of the BJI Inoplex 2 test in conjunction with the clinical and laboratory data collected: diagnostic strategy and score combining several criteria.
To evaluate the potential medical and economic benefits of using the test: number and cost of joint aspirations or hospital stays that would have been avoided, delayed diagnosis.
To describe the serological outcome after surgery in septic patients.
arm group label: Septic patient group
description: The septic patient group will be comprised of patients presenting with bone and joint prosthetic device infection confirmed by intraoperative microbiological culture (at least 2 deep positive samples for the same bacterial strain).
arm group label: Non-septic patient group
description: The non-septic patient group will be comprised of prosthetic patients presenting with symptoms of mechanical loosening, and whose deep intraoperative samples have all proved negative
arm group label: Intermediate group
description: An intermediate group will be comprised of patients with only one deep positive sample.
Serologic assays of sera collected from septic or non-septic patients will be performed in
      series and operators will be blind in terms of clinical and microbiological status in order
      to avoid any interpretation bias due to information collected in advance
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases