<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/NCT03295045</url>
  </required_header>
  <id_info>
    <org_study_id>N/2007/50</org_study_id>
    <nct_id>NCT03295045</nct_id>
  </id_info>
  <brief_title>Evolution of the Profile of Infectious Endocarditis in France in 2008 (EI2008)</brief_title>
  <acronym>EI2008</acronym>
  <official_title>Evolution of the Profile of Infectious Endocarditis in France in 2008</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bichat Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hopital Louis Pradel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CHU de Reims</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hotel Dieu Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Henri Mondor University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</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>
      Infective endocarditis (IE) is a rare (30 cases / million / year in France) and serious (20 %&#xD;
      of deaths during hospitalization) disease . Its epidemiological profile was considerably&#xD;
      modified these last years.New predisposing factors appeared, due to increasing number of&#xD;
      patients wearing valvular prosthetics. The purpose of this study is to realize in 2008 a new&#xD;
      observational study on populational basis to describe and analyze the evolution of the&#xD;
      epidemiology of IE in France, compared to previous studies conducted in 1991 and 1999.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is a prospective observational study based on a population of 25 million inhabitants. The&#xD;
      cases are recruited over a one year period, from January 1st till December 31st, 2008, in six&#xD;
      regions of France (Rhône-Alpes, Paris et Petite Couronne, Lorraine, Franche-Comté, Marne,&#xD;
      Languedoc-Roussillon) and in the department of Ille-et-Vilaine. The IE cases are declared by&#xD;
      clinicians taking care of the patients, microbiologists and cardiac ultrasonographists.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2007</start_date>
  <completion_date type="Actual">December 31, 2010</completion_date>
  <primary_completion_date type="Actual">December 31, 2009</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>1 year</time_frame>
    <description>Vital status</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of antibiotic resistance by the germs (streptococci and staphylococci)</measure>
    <time_frame>during the hospitalization, 1 year maximum</time_frame>
    <description>antibiotic treatments and outcome</description>
  </secondary_outcome>
  <enrollment type="Actual">484</enrollment>
  <condition>Infective Endocarditis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Inpatients with infective endocarditis living in one of the studied regions&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major Patient&#xD;
&#xD;
          -  Supported in one of the participating centers&#xD;
&#xD;
          -  The application of diagnostic classification criteria of Duke modified by Li is&#xD;
             carried out after collection of all the data at the output of the patient. Will be&#xD;
             included in the observatory that patients meeting criteria for definite or possible&#xD;
             endocarditis.&#xD;
&#xD;
               -  Affiliated with the French social security regime&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not living in one of the studied regions&#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>Bruno HOEN, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Pointe à Pitre</affiliation>
  </overall_official>
  <results_reference>
    <citation>Selton-Suty C, Celard M, Le Moing V, Doco-Lecompte T, Chirouze C, Iung B, Strady C, Revest M, Vandenesch F, Bouvet A, Delahaye F, Alla F, Duval X, Hoen B; AEPEI Study Group. Preeminence of Staphylococcus aureus in infective endocarditis: a 1-year population-based survey. Clin Infect Dis. 2012 May;54(9):1230-9. doi: 10.1093/cid/cis199.</citation>
    <PMID>22492317</PMID>
  </results_reference>
  <results_reference>
    <citation>Duval X, Delahaye F, Alla F, Tattevin P, Obadia JF, Le Moing V, Doco-Lecompte T, Celard M, Poyart C, Strady C, Chirouze C, Bes M, Cambau E, Iung B, Selton-Suty C, Hoen B; AEPEI Study Group. Temporal trends in infective endocarditis in the context of prophylaxis guideline modifications: three successive population-based surveys. J Am Coll Cardiol. 2012 May 29;59(22):1968-76. doi: 10.1016/j.jacc.2012.02.029.</citation>
    <PMID>22624837</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>September 26, 2017</last_update_submitted>
  <last_update_submitted_qc>September 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2017</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, Subacute Bacterial</mesh_term>
    <mesh_term>Endocarditis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03295045
org study id: N/2007/50
nct id: NCT03295045
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Infective endocarditis (IE) is a rare (30 cases / million / year in France) and serious (20 %
      of deaths during hospitalization) disease . Its epidemiological profile was considerably
      modified these last years.New predisposing factors appeared, due to increasing number of
      patients wearing valvular prosthetics. The purpose of this study is to realize in 2008 a new
      observational study on populational basis to describe and analyze the evolution of the
      epidemiology of IE in France, compared to previous studies conducted in 1991 and 1999.
It is a prospective observational study based on a population of 25 million inhabitants. The
      cases are recruited over a one year period, from January 1st till December 31st, 2008, in six
      regions of France (Rhône-Alpes, Paris et Petite Couronne, Lorraine, Franche-Comté, Marne,
      Languedoc-Roussillon) and in the department of Ille-et-Vilaine. The IE cases are declared by
      clinicians taking care of the patients, microbiologists and cardiac ultrasonographists.
observational model: Cohort
time perspective: Prospective
measure: Mortality
time frame: 1 year
description: Vital status
measure: Frequency of antibiotic resistance by the germs (streptococci and staphylococci)
time frame: during the hospitalization, 1 year maximum
description: antibiotic treatments and outcome
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bruno HOEN, MD PhD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Pointe à Pitre
citation: Selton-Suty C, Celard M, Le Moing V, Doco-Lecompte T, Chirouze C, Iung B, Strady C, Revest M, Vandenesch F, Bouvet A, Delahaye F, Alla F, Duval X, Hoen B; AEPEI Study Group. Preeminence of Staphylococcus aureus in infective endocarditis: a 1-year population-based survey. Clin Infect Dis. 2012 May;54(9):1230-9. doi: 10.1093/cid/cis199.
PMID: 22492317
citation: Duval X, Delahaye F, Alla F, Tattevin P, Obadia JF, Le Moing V, Doco-Lecompte T, Celard M, Poyart C, Strady C, Chirouze C, Bes M, Cambau E, Iung B, Selton-Suty C, Hoen B; AEPEI Study Group. Temporal trends in infective endocarditis in the context of prophylaxis guideline modifications: three successive population-based surveys. J Am Coll Cardiol. 2012 May 29;59(22):1968-76. doi: 10.1016/j.jacc.2012.02.029.
PMID: 22624837
responsible party type: Sponsor
mesh term: Endocarditis, Bacterial
mesh term: Endocarditis, Subacute Bacterial
mesh term: Endocarditis
sharing ipd: No