<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/NCT03306225</url>
  </required_header>
  <id_info>
    <org_study_id>ENDOSTREPTO</org_study_id>
    <nct_id>NCT03306225</nct_id>
  </id_info>
  <brief_title>Characterization of Endocarditis to Streptococci and Impact of the CMI on the Future of the Patients</brief_title>
  <official_title>Characterization of Endocarditis to Streptococci and Impact of the CMI on the Future of the Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</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>
      The infectious endocarditis is a grave infection the incidence of which is at present&#xD;
      esteemed at 30-100 episodes by million inhabitants a year.&#xD;
&#xD;
      This infection is marked with a heavy morbi-mortality.Preliminary studies seem to show an&#xD;
      abnormally high death rate at the patients presenting an infectious endocarditis to&#xD;
      streptococci with an inhibitive minimal concentration raised to the amoxicilline. The aim of&#xD;
      the study is to describe the epidemiology and the clinical presentations of the patients&#xD;
      presenting an endocarditis to streptococci&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2016</start_date>
  <completion_date type="Actual">December 31, 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>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of factors associated to the mortality in the patients presenting an endocarditis to streptococci.</measure>
    <time_frame>an average of one year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">414</enrollment>
  <condition>Endocarditis, Bacterial</condition>
  <eligibility>
    <study_pop>
      <textblock>
        all patient diagnostised for endocarditis between 2010 and 2015&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  endocartitis with steptococci with Duke's criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  suspiscious endocarditis without Duke's criteria&#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>PILMIS P Benoit, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation Hôpital Saint-Joseph</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>October 5, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>February 3, 2020</last_update_submitted>
  <last_update_submitted_qc>February 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endocarditis, Bacterial</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/NCT03306225
org study id: ENDOSTREPTO
nct id: NCT03306225
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The infectious endocarditis is a grave infection the incidence of which is at present
      esteemed at 30-100 episodes by million inhabitants a year.

      This infection is marked with a heavy morbi-mortality.Preliminary studies seem to show an
      abnormally high death rate at the patients presenting an infectious endocarditis to
      streptococci with an inhibitive minimal concentration raised to the amoxicilline. The aim of
      the study is to describe the epidemiology and the clinical presentations of the patients
      presenting an endocarditis to streptococci
observational model: Cohort
time perspective: Retrospective
measure: Evaluation of factors associated to the mortality in the patients presenting an endocarditis to streptococci.
time frame: an average of one year
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: PILMIS P Benoit, MD
role: Principal Investigator
affiliation: Fondation Hôpital Saint-Joseph
facility: 
country: France
responsible party type: Sponsor
mesh term: Endocarditis, Bacterial
mesh term: Endocarditis