<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/NCT01731483</url>
  </required_header>
  <id_info>
    <org_study_id>M-1</org_study_id>
    <nct_id>NCT01731483</nct_id>
  </id_info>
  <brief_title>Coagulation and Fibrinolysis as Virulence Factors for Invasive Staphylococcus Aureus and Streptococcus Infections</brief_title>
  <official_title>Coagulation and Fibrinolysis as Virulence Factors for Invasive Staphylococcus Aureus and Streptococcus Infections.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      the aim of this study is to investigate the role of staphylokinase, streptokinase and MMP&#xD;
      activation in invasive staphylococcal and streptococcal infections.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">March 18, 2020</completion_date>
  <primary_completion_date type="Actual">March 2020</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>proteolytic activity</measure>
    <time_frame>1 day (on date of surgery (tissue sample))</time_frame>
  </primary_outcome>
  <enrollment type="Actual">89</enrollment>
  <condition>Infective Endocarditis</condition>
  <condition>Necrotizing Fasciitis</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      tissue specimens from endocarditis lesions and necrotizing fasciitis&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Material will be collected from all patients that undergo surgical treatment for invasive&#xD;
        streptococcal or staphylococcal infections, including acute infective endocarditis and&#xD;
        necrotizing fasciitis, from the UZ Leuven University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients that undergo surgical treatment for invasive streptococcal or&#xD;
             staphylococcal infections, including acute infective endocarditis and necrotizing&#xD;
             fasciitis, from the UZ Leuven University Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Verhamme, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitaire Ziekenhuizen KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven University Hospital</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>September 1, 2023</last_update_submitted>
  <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitaire Ziekenhuizen KU Leuven</investigator_affiliation>
    <investigator_full_name>Peter Verhamme</investigator_full_name>
    <investigator_title>Prof. Verhamme</investigator_title>
  </responsible_party>
  <keyword>virulence factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endocarditis, Bacterial</mesh_term>
    <mesh_term>Streptococcal Infections</mesh_term>
    <mesh_term>Fasciitis</mesh_term>
    <mesh_term>Fasciitis, Necrotizing</mesh_term>
    <mesh_term>Endocarditis</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/NCT01731483
org study id: M-1
nct id: NCT01731483
lead sponsor: 
has dmc: No
the aim of this study is to investigate the role of staphylokinase, streptokinase and MMP
      activation in invasive staphylococcal and streptococcal infections.
observational model: Case-Only
time perspective: Prospective
measure: proteolytic activity
time frame: 1 day (on date of surgery (tissue sample))
tissue specimens from endocarditis lesions and necrotizing fasciitis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Peter Verhamme, MD,PhD
role: Principal Investigator
affiliation: Universitaire Ziekenhuizen KU Leuven
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universitaire Ziekenhuizen KU Leuven
investigator full name: Peter Verhamme
investigator title: Prof. Verhamme
mesh term: Endocarditis, Bacterial
mesh term: Streptococcal Infections
mesh term: Fasciitis
mesh term: Fasciitis, Necrotizing
mesh term: Endocarditis