<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/NCT01677000</url>
  </required_header>
  <id_info>
    <org_study_id>CPP Infection Registry</org_study_id>
    <nct_id>NCT01677000</nct_id>
  </id_info>
  <brief_title>Clinical Priority Program-Bone Infection Registry</brief_title>
  <acronym>CPPInfection</acronym>
  <official_title>Clinical Priority Program: Bone Infection; Use of a Registry on Infection to Improve Patient Outcomes and Research Efforts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AO Clinical Investigation and Publishing Documentation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AO Innovation Translation Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Establish an international registry of over 400 patients with deep infections involving the&#xD;
      bone and/or joint from≥20 centers representing all regions of the world with varied hospital&#xD;
      and surgeon practice settings to ensure that registry analyses and research reflect typical&#xD;
      clinical practice thereby providing optimal guidance for patients, clinicians, and healthcare&#xD;
      researchers. Using a data collection platform that minimizes entry burden, collects most&#xD;
      information at the time of surgery, and uses Internet technology to minimize data entry. The&#xD;
      registry will include:&#xD;
&#xD;
        1. baseline patient attributes;&#xD;
&#xD;
        2. surgical approach, implants and technology;&#xD;
&#xD;
        3. hospital course;&#xD;
&#xD;
        4. surgeon and institutional characteristics;&#xD;
&#xD;
        5. longitudinal patient outcome,&#xD;
&#xD;
        6. post-procedure complications and revisions,&#xD;
&#xD;
        7. serum/tissue/drainage samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Establish an international registry with AOCID of over 400 patients with deep infections&#xD;
      involving the bone and/or joint from ≥ 20 centers representing all regions of the world with&#xD;
      varied hospital and surgeon practice settings to ensure that registry analyses and research&#xD;
      reflect typical clinical practice thereby providing optimal guidance for patients,&#xD;
      clinicians, and healthcare researchers. Creation of an AOCID Registry for musculoskeletal&#xD;
      infection cases will permit better analysis of the causes, contributing factors including&#xD;
      patient immune responses, treatments and clinical outcomes of musculoskeletal infections.&#xD;
&#xD;
        -  Establish a practice network that includes ≥ 20 geographically distributed centers.&#xD;
           These busy practices will be treating patients with varied geographic status to assure&#xD;
           balanced representation of diverse patients and practices.&#xD;
&#xD;
        -  Establish a Data Coordinating Core team with AOCID using a data collection platform that&#xD;
           minimizes entry burden, collects most information at the time of surgery, and uses&#xD;
           Internet technology to minimize data entry.&#xD;
&#xD;
      The registry will include:&#xD;
&#xD;
        -  baseline patient attributes&#xD;
&#xD;
        -  surgical approach, implants and technology&#xD;
&#xD;
        -  hospital course&#xD;
&#xD;
        -  surgeon and institutional characteristics&#xD;
&#xD;
        -  longitudinal patient outcome&#xD;
&#xD;
        -  post-procedure complications and revisions&#xD;
&#xD;
        -  serum/tissue/drainage samples&#xD;
&#xD;
             -  Establish a Statistical Support team with AOCID to implement cutting-edge&#xD;
                statistical techniques including the use of hierarchical generalized linear latent&#xD;
                and mixed effects models to address the complex structure and longitudinal nature&#xD;
                of registry data. Multivariable predictive models for outcome(s) of infection will&#xD;
                be developed.&#xD;
&#xD;
             -  Establish an Outcomes Measurement Team with AOCID and Investigators from the CPP&#xD;
                team to advance the science of infection-specific and global patient-reported&#xD;
                outcomes to support efficient data collection of web-based, longitudinal data in&#xD;
                this registry and future comparative effectiveness research.&#xD;
&#xD;
             -  Develop new assessment tools and conduct research useful to clinical practice.&#xD;
                Establish consensus on the definition of treatment failure- characterized as lack&#xD;
                of clinically meaningful improvement in infection, pain or physical function&#xD;
                following treatment, validate, and refine prediction algorithms for patients at&#xD;
                risk for failure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">June 30, 2019</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-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Details on occurence and treatment of bone infection</measure>
    <time_frame>1 December 2012</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgical approach, implants and technology</measure>
    <time_frame>01 December 2012</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient outcome</measure>
    <time_frame>01 December 2012</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-procedure complications and revisions</measure>
    <time_frame>01 December 2012</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">297</enrollment>
  <condition>Bone Infection</condition>
  <condition>Staphylococcus Aureus</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood samples nasal and wound specimen&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patients with diagnosis of Staphylococcus aureus bone infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18 years or older&#xD;
&#xD;
          -  Confirmed* oxacillin-/methicillin-sensitive Staphylococcus aureus (OSSA/ MSSA) or&#xD;
             methicillin resistant Staphylococcus aureus (MRSA) infection involving a long bone&#xD;
             (ie, femur, tibia, fibula, humerus, radius, ulna, and clavicle) with one (or a&#xD;
             combination) of the following:&#xD;
&#xD;
               -  Osteomyelitis&#xD;
&#xD;
               -  Fracture fixation hardware /prosthetic joint infection&#xD;
&#xD;
               -  Infection around an arthroplasty&#xD;
&#xD;
          -  Ability to understand the content of the patient information / informed consent form&#xD;
             and to participate in the clinical investigation&#xD;
&#xD;
          -  Signed written informed consent * Confirmed either by positive culture from baseline&#xD;
             examination or by positive culture from a prior examination of the same surgical site&#xD;
             and definitely ongoing infection with Staphylococcus aureus according to the treating&#xD;
             surgeon&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who cannot give informed consent&#xD;
&#xD;
          -  Patients who cannot attend the follow up visits&#xD;
&#xD;
          -  Recent history of substance abuse (ie, recreational drugs, alcohol) that would&#xD;
             preclude reliable assessment&#xD;
&#xD;
          -  Prisoner&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen L Kates, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Richmond</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Missouri Health Care</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unity Hospital</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14626</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Health System</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Richmond, Department of Orthopaedic Surgery</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Italiano de Buenos Aires</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1181ACH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitaetsklinik Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foothills Medical Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>AB T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwestern Hospital Chongqing</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Zunyi Medical College</name>
      <address>
        <city>Zunyi</city>
        <state>Guizhou</state>
        <zip>56003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Provincial People's Hospital</name>
      <address>
        <city>Hangzhou</city>
        <zip>310014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Berufsgenossenschaftliche Unfallklinik Murnau</name>
      <address>
        <city>Murnau am Staffelsee</city>
        <state>Bavaria</state>
        <zip>82418</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Justus-Liebig-Universität</name>
      <address>
        <city>Giessen</city>
        <zip>35592</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Regensburg</name>
      <address>
        <city>Regensburg</city>
        <zip>93042</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Graduate School of Medicine</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>060-8638</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamawaki Orthopaedic Hospital</name>
      <address>
        <city>Hiroshima</city>
        <zip>730-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsspital Basel</name>
      <address>
        <city>Basel</city>
        <state>Basel Stadt</state>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>China</country>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Japan</country>
    <country>Switzerland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bone infection</keyword>
  <keyword>staphylococcus aureus</keyword>
  <keyword>registry</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>Osteomyelitis</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/NCT01677000
org study id: CPP Infection Registry
nct id: NCT01677000
lead sponsor: 
has dmc: Yes
Establish an international registry of over 400 patients with deep infections involving the
      bone and/or joint from≥20 centers representing all regions of the world with varied hospital
      and surgeon practice settings to ensure that registry analyses and research reflect typical
      clinical practice thereby providing optimal guidance for patients, clinicians, and healthcare
      researchers. Using a data collection platform that minimizes entry burden, collects most
      information at the time of surgery, and uses Internet technology to minimize data entry. The
      registry will include:

        1. baseline patient attributes;

        2. surgical approach, implants and technology;

        3. hospital course;

        4. surgeon and institutional characteristics;

        5. longitudinal patient outcome,

        6. post-procedure complications and revisions,

        7. serum/tissue/drainage samples.
Establish an international registry with AOCID of over 400 patients with deep infections
      involving the bone and/or joint from ≥ 20 centers representing all regions of the world with
      varied hospital and surgeon practice settings to ensure that registry analyses and research
      reflect typical clinical practice thereby providing optimal guidance for patients,
      clinicians, and healthcare researchers. Creation of an AOCID Registry for musculoskeletal
      infection cases will permit better analysis of the causes, contributing factors including
      patient immune responses, treatments and clinical outcomes of musculoskeletal infections.

        -  Establish a practice network that includes ≥ 20 geographically distributed centers.
           These busy practices will be treating patients with varied geographic status to assure
           balanced representation of diverse patients and practices.

        -  Establish a Data Coordinating Core team with AOCID using a data collection platform that
           minimizes entry burden, collects most information at the time of surgery, and uses
           Internet technology to minimize data entry.

      The registry will include:

        -  baseline patient attributes

        -  surgical approach, implants and technology

        -  hospital course

        -  surgeon and institutional characteristics

        -  longitudinal patient outcome

        -  post-procedure complications and revisions

        -  serum/tissue/drainage samples

             -  Establish a Statistical Support team with AOCID to implement cutting-edge
                statistical techniques including the use of hierarchical generalized linear latent
                and mixed effects models to address the complex structure and longitudinal nature
                of registry data. Multivariable predictive models for outcome(s) of infection will
                be developed.

             -  Establish an Outcomes Measurement Team with AOCID and Investigators from the CPP
                team to advance the science of infection-specific and global patient-reported
                outcomes to support efficient data collection of web-based, longitudinal data in
                this registry and future comparative effectiveness research.

             -  Develop new assessment tools and conduct research useful to clinical practice.
                Establish consensus on the definition of treatment failure- characterized as lack
                of clinically meaningful improvement in infection, pain or physical function
                following treatment, validate, and refine prediction algorithms for patients at
                risk for failure.
observational model: Case-Only
time perspective: Prospective
measure: Details on occurence and treatment of bone infection
time frame: 1 December 2012
measure: Surgical approach, implants and technology
time frame: 01 December 2012
measure: Patient outcome
time frame: 01 December 2012
measure: Post-procedure complications and revisions
time frame: 01 December 2012
blood samples nasal and wound specimen
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 130 Years
healthy volunteers: No
last name: Stephen L Kates, MD
role: Principal Investigator
affiliation: University of Richmond
facility: 
facility: 
facility: 
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facility: 
facility: 
facility: 
facility: 
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facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: Argentina
country: Austria
country: Belgium
country: Canada
country: China
country: Denmark
country: Germany
country: Japan
country: Switzerland
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Osteomyelitis