<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/NCT03272724</url>
  </required_header>
  <id_info>
    <org_study_id>Observatoire EI</org_study_id>
    <nct_id>NCT03272724</nct_id>
  </id_info>
  <brief_title>French National Observatory on Infective Endocarditis</brief_title>
  <acronym>ObservatoireEI</acronym>
  <official_title>French National Observatory on Infective Endocarditis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bichat Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Universitaire de Pointe-a-Pitre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital Saint André, Reims</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Henri Mondor University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Polyclinique Courlancy, Reims</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bicetre Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Universitaire, Amiens</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Annecy Genevois</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier de Roanne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre hospitalier Pierre Oudot Bourgoin-Jallieu</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital d'Instruction des Armées Desgenettes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital intercommunal Sud Léman Valserine, Saint Julien en Genevois</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Cardiologique du Nord</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Intercommunal Robert Ballanger</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Raincy Montfermeil Hospital Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pitié-Salpêtrière Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital Cochin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Avicenne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beaujon Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>European Georges Pompidou Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hotel Dieu Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital Jean Verdier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hopital Lariboisière</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital Necker-Enfants Malades</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Saint-Louis Hospital, Paris, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tenon Hospital, Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Saint Antoine University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre hospitalier de Saint Dié des Vosges</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Régional Metz-Thionville</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital d'Instruction des Armées Legouest</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital sainte Blandine Metz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital-clinique Claude Bernard, Metz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Polyclinique Louis Pasteur Essey-les-Nancy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hopital Nord Franche-Comte</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lons le Saunier hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pontarlier hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Epernay hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chalons en Champagne hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Clinique Saint Vincent Epernay</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital Maison Blanche Reims</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hopital Universitaire Robert-Debre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beziers Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Louis Pasteur hospital, Bagnols sur Cèze</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre hospitalier de Perpignan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Narbonne Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Clinique du Millenaire</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Saint Malo hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>HIA Begin, Saint Mandé</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier d'Alès-Cévennes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre hospitalier de Chambéry</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Intercommunal Villeneuve Saint Georges</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Argenteuil</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital St. Joseph, Marseille, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Central Hospital, Nancy, France</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 objective of this observatory is to provide a national database of infective&#xD;
      endocarditis, informed by all volunteer centers, using a standardized case report forms.&#xD;
&#xD;
      Such an observatory will describe the clinical profile, microbiological, therapeutic and&#xD;
      evolving of infective endocarditis (IE); analyze the risk factors for the disease and its&#xD;
      prognosis factors of evolution; describe management practices; evaluate and compare in the&#xD;
      real drug treatment strategies (including antibiotics) and surgical.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All the clinical, biological, microbiological and laboratory describing the history of&#xD;
      patients and their evolution during hospitalization for infective endocarditis will be&#xD;
      obtained from physicians supporting patients and recorded in an electronic case report form.&#xD;
      Will include collected clinical characteristics (site, pre-existing heart disease underlying&#xD;
      symptoms, complications), biological characteristics (dosage on admission and diagnosis),&#xD;
      microbiological characteristics (identifying the genus and species of the microorganism&#xD;
      responsible, sensitivity to antibiotics susceptibility testing and evaluated by determination&#xD;
      of minimal inhibiting concentration (MIC), exhaustive search of the rare forms of&#xD;
      endocarditis uncultivated microorganisms), an analysis of the gateways based on the causative&#xD;
      organism; echocardiographic characteristics (number and size of vegetations, valvular damage,&#xD;
      scalable: surgery, lethality) and therapeutic characteristics (antibiotic treatment,&#xD;
      surgical).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 1991</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>history of heart disease</measure>
    <time_frame>inclusion</time_frame>
    <description>status of heart valves, pre-existing heart conditions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>risk factors, medical history</measure>
    <time_frame>inclusion</time_frame>
    <description>associated diseases</description>
  </primary_outcome>
  <primary_outcome>
    <measure>origin of infection</measure>
    <time_frame>period of 3 months before infective endocarditis</time_frame>
    <description>high risk procedures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>weight</measure>
    <time_frame>inclusion</time_frame>
    <description>kg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>height</measure>
    <time_frame>inclusion</time_frame>
    <description>cm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>clinical symptoms</measure>
    <time_frame>inclusion</time_frame>
    <description>cardiac, peripheral and neurological symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>biological outcomes</measure>
    <time_frame>inclusion</time_frame>
    <description>blood count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>microbiological outcomes</measure>
    <time_frame>inclusion</time_frame>
    <description>identification of infecting organisms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>diagnostic imaging</measure>
    <time_frame>inclusion</time_frame>
    <description>description of tyhe imaging tests performed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>antibiotic therapy</measure>
    <time_frame>from inclusion to recovery</time_frame>
    <description>antibiotic treatment: type and duration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>surgical procedures</measure>
    <time_frame>from inclusion to recovery</time_frame>
    <description>description of surgical procedures</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>biologic collection (optional)</measure>
    <time_frame>inclusion</time_frame>
    <description>plasma and serum collection</description>
  </secondary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Infective Endocarditis</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum, plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult hospitalized patients, suspected of infective endocarditis&#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 end of the patient's&#xD;
             hospitalization. Only patients meeting criteria for definite or possible endocarditis&#xD;
             will be included in the analyses.&#xD;
&#xD;
          -  Registered with the French social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Refusal of the patient to participate.&#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>Christine SELTON-SUTY, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHRU Nancy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nadine JUGE, PhD</last_name>
    <email>n.juge@chru-nancy.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHRU</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christine SELTON-SUTY, MD</last_name>
      <email>c.suty-selton@chru-nancy.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Selton-Suty C, Goehringer F, Venner C, Thivilier C, Huttin O, Hoen B; membres de l'Endocarditis Team du CHU de Nancy. [Complications and prognosis of infective endocarditis]. Presse Med. 2019 May;48(5):532-538. doi: 10.1016/j.lpm.2019.04.002. Epub 2019 May 2. French.</citation>
    <PMID>31056233</PMID>
  </results_reference>
  <results_reference>
    <citation>Hoen B, Elfarra M, Huttin O, Goehringer F, Venner C, Selton-Suty C; l'Endocarditis Team du CHU de Nancy. [Treatment of infectious endocarditis]. Presse Med. 2019 May;48(5):539-548. doi: 10.1016/j.lpm.2019.04.015. Epub 2019 May 18. French.</citation>
    <PMID>31109766</PMID>
  </results_reference>
  <results_reference>
    <citation>N'Guyen Y, Duval X, Revest M, Saada M, Erpelding ML, Selton-Suty C, Bouchiat C, Delahaye F, Chirouze C, Alla F, Strady C, Hoen B; AEPEI study group. Time interval between infective endocarditis first symptoms and diagnosis: relationship to infective endocarditis characteristics, microorganisms and prognosis. Ann Med. 2017 Mar;49(2):117-125. doi: 10.1080/07853890.2016.1235282. Epub 2016 Nov 3.</citation>
    <PMID>27607562</PMID>
  </results_reference>
  <results_reference>
    <citation>Lefevre B, Hoen B, Goehringer F, Sime WN, Aissa N, Alauzet C, Jeanmaire E, Henard S, Filippetti L, Selton-Suty C, Agrinier N; for AEPEI study group (Association pour l'Etude et la Prevention de l'Endocardite Infectieuse). Antistaphylococcal penicillins vs. cefazolin in the treatment of methicillin-susceptible Staphylococcus aureus infective endocarditis: a quasi-experimental monocentre study. Eur J Clin Microbiol Infect Dis. 2021 Dec;40(12):2605-2616. doi: 10.1007/s10096-021-04313-3. Epub 2021 Aug 12.</citation>
    <PMID>34383175</PMID>
  </results_reference>
  <results_reference>
    <citation>Collonnaz M, Erpelding ML, Alla F, Goehringer F, Delahaye F, Iung B, Le Moing V, Hoen B, Selton-Suty C, Agrinier N; AEPEI Study Group. Impact of referral bias on prognostic studies outcomes: insights from a population-based cohort study on infective endocarditis. Ann Epidemiol. 2021 Feb;54:29-37. doi: 10.1016/j.annepidem.2020.09.008. Epub 2020 Sep 18.</citation>
    <PMID>32950657</PMID>
  </results_reference>
  <results_reference>
    <citation>Collonnaz M, Erpelding ML, Alla F, Goehringer F, Delahaye F, Iung B, Le Moing V, Hoen B, Selton-Suty C, Agrinier N; AEPEI study group. Data on prognostic factors associated with 3-month and 1-year mortality from infective endocarditis. Data Brief. 2020 Nov 1;33:106478. doi: 10.1016/j.dib.2020.106478. eCollection 2020 Dec.</citation>
    <PMID>33225027</PMID>
  </results_reference>
  <results_reference>
    <citation>De Ciancio G, Erpelding ML, Filippetti L, Goehringer F, Blangy H, Huttin O, Agrinier N, Juilliere Y, Sadoul N, Selton-Suty C. Adherence to diagnostic and therapeutic practice guidelines for suspected cardiac implantable electronic device infections. Arch Cardiovasc Dis. 2021 Oct;114(10):634-646. doi: 10.1016/j.acvd.2021.06.010. Epub 2021 Nov 3.</citation>
    <PMID>34742672</PMID>
  </results_reference>
  <results_reference>
    <citation>Selton-Suty C, Delahaye F, Tattevin P, Federspiel C, Le Moing V, Chirouze C, Nazeyrollas P, Vernet-Garnier V, Bernard Y, Chocron S, Obadia JF, Alla F, Hoen B, Duval X; AEPEI (Association pour l'Etude et la Prevention de l'Endocardite Infectieuse). Symptomatic and Asymptomatic Neurological Complications of Infective Endocarditis: Impact on Surgical Management and Prognosis. PLoS One. 2016 Jul 11;11(7):e0158522. doi: 10.1371/journal.pone.0158522. eCollection 2016.</citation>
    <PMID>27400273</PMID>
  </results_reference>
  <results_reference>
    <citation>Radjabaly Mandjee A, Filippetti L, Goehringer F, Duval X, Botelho-Nevers E, Tribouilloy C, Huguet R, Chirouze C, Erpelding ML, Hoen B, Selton-Suty C, Agrinier N, Lefevre B; investigators of the French AEPEI Observatory on Infective Endocarditis (Association pour l'Etude et la Prevention de l'Endocardite Infectieuse). Characteristics of patients with infective endocarditis and no underlying cardiac conditions. Infect Dis (Lond). 2022 Sep;54(9):656-665. doi: 10.1080/23744235.2022.2078404. Epub 2022 May 23.</citation>
    <PMID>35604065</PMID>
  </results_reference>
  <results_reference>
    <citation>Beraud G, Tubiana S, Erpelding ML, Le Moing V, Chirouze C, Gorenne I, Manchon P, Tattevin P, Vernet V, Varon E, Hoen B, Duval X; AEPEI study group; COMBAT study group. Combined Bacterial Meningitis and Infective Endocarditis: When Should We Search for the Other When Either One is Diagnosed? Infect Dis Ther. 2022 Aug;11(4):1521-1540. doi: 10.1007/s40121-022-00651-7. Epub 2022 May 26.</citation>
    <PMID>35618954</PMID>
  </results_reference>
  <results_reference>
    <citation>Lefevre B, Legoff A, Boutrou M, Goehringer F, Ngueyon-Sime W, Chirouze C, Revest M, Vernet Garnier V, Duval X, Delahaye F, Le Moing V, Selton-Suty C, Filippetti L, Hoen B, Agrinier N. Staphylococcus aureus endocarditis: Identifying prognostic factors using a method derived from morbidity and mortality conferences. Front Med (Lausanne). 2022 Dec 6;9:1053278. doi: 10.3389/fmed.2022.1053278. eCollection 2022.</citation>
    <PMID>36561723</PMID>
  </results_reference>
  <results_reference>
    <citation>Fowler VG, Durack DT, Selton-Suty C, Athan E, Bayer AS, Chamis AL, Dahl A, DiBernardo L, Durante-Mangoni E, Duval X, Fortes CQ, Fosbol E, Hannan MM, Hasse B, Hoen B, Karchmer AW, Mestres CA, Petti CA, Pizzi MN, Preston SD, Roque A, Vandenesch F, van der Meer JTM, van der Vaart TW, Miro JM. The 2023 Duke-International Society for Cardiovascular Infectious Diseases Criteria for Infective Endocarditis: Updating the Modified Duke Criteria. Clin Infect Dis. 2023 Aug 22;77(4):518-526. doi: 10.1093/cid/ciad271.</citation>
    <PMID>37138445</PMID>
  </results_reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Central Hospital, Nancy, France</investigator_affiliation>
    <investigator_full_name>Christine Selton-Suty</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </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>
  <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/NCT03272724
org study id: Observatoire EI
nct id: NCT03272724
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has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this observatory is to provide a national database of infective
      endocarditis, informed by all volunteer centers, using a standardized case report forms.

      Such an observatory will describe the clinical profile, microbiological, therapeutic and
      evolving of infective endocarditis (IE); analyze the risk factors for the disease and its
      prognosis factors of evolution; describe management practices; evaluate and compare in the
      real drug treatment strategies (including antibiotics) and surgical.
All the clinical, biological, microbiological and laboratory describing the history of
      patients and their evolution during hospitalization for infective endocarditis will be
      obtained from physicians supporting patients and recorded in an electronic case report form.
      Will include collected clinical characteristics (site, pre-existing heart disease underlying
      symptoms, complications), biological characteristics (dosage on admission and diagnosis),
      microbiological characteristics (identifying the genus and species of the microorganism
      responsible, sensitivity to antibiotics susceptibility testing and evaluated by determination
      of minimal inhibiting concentration (MIC), exhaustive search of the rare forms of
      endocarditis uncultivated microorganisms), an analysis of the gateways based on the causative
      organism; echocardiographic characteristics (number and size of vegetations, valvular damage,
      scalable: surgery, lethality) and therapeutic characteristics (antibiotic treatment,
      surgical).
observational model: Cohort
time perspective: Other
measure: history of heart disease
time frame: inclusion
description: status of heart valves, pre-existing heart conditions
measure: risk factors, medical history
time frame: inclusion
description: associated diseases
measure: origin of infection
time frame: period of 3 months before infective endocarditis
description: high risk procedures
measure: weight
time frame: inclusion
description: kg
measure: height
time frame: inclusion
description: cm
measure: clinical symptoms
time frame: inclusion
description: cardiac, peripheral and neurological symptoms
measure: biological outcomes
time frame: inclusion
description: blood count
measure: microbiological outcomes
time frame: inclusion
description: identification of infecting organisms
measure: diagnostic imaging
time frame: inclusion
description: description of tyhe imaging tests performed
measure: antibiotic therapy
time frame: from inclusion to recovery
description: antibiotic treatment: type and duration
measure: surgical procedures
time frame: from inclusion to recovery
description: description of surgical procedures
measure: biologic collection (optional)
time frame: inclusion
description: plasma and serum collection
serum, plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christine SELTON-SUTY, MD
role: Principal Investigator
affiliation: CHRU Nancy
last name: Nadine JUGE, PhD
email: n.juge@chru-nancy.fr
facility: 
status: Recruiting
contact: 
country: France
citation: Selton-Suty C, Goehringer F, Venner C, Thivilier C, Huttin O, Hoen B; membres de l'Endocarditis Team du CHU de Nancy. [Complications and prognosis of infective endocarditis]. Presse Med. 2019 May;48(5):532-538. doi: 10.1016/j.lpm.2019.04.002. Epub 2019 May 2. French.
PMID: 31056233
citation: Hoen B, Elfarra M, Huttin O, Goehringer F, Venner C, Selton-Suty C; l'Endocarditis Team du CHU de Nancy. [Treatment of infectious endocarditis]. Presse Med. 2019 May;48(5):539-548. doi: 10.1016/j.lpm.2019.04.015. Epub 2019 May 18. French.
PMID: 31109766
citation: N'Guyen Y, Duval X, Revest M, Saada M, Erpelding ML, Selton-Suty C, Bouchiat C, Delahaye F, Chirouze C, Alla F, Strady C, Hoen B; AEPEI study group. Time interval between infective endocarditis first symptoms and diagnosis: relationship to infective endocarditis characteristics, microorganisms and prognosis. Ann Med. 2017 Mar;49(2):117-125. doi: 10.1080/07853890.2016.1235282. Epub 2016 Nov 3.
PMID: 27607562
citation: Lefevre B, Hoen B, Goehringer F, Sime WN, Aissa N, Alauzet C, Jeanmaire E, Henard S, Filippetti L, Selton-Suty C, Agrinier N; for AEPEI study group (Association pour l'Etude et la Prevention de l'Endocardite Infectieuse). Antistaphylococcal penicillins vs. cefazolin in the treatment of methicillin-susceptible Staphylococcus aureus infective endocarditis: a quasi-experimental monocentre study. Eur J Clin Microbiol Infect Dis. 2021 Dec;40(12):2605-2616. doi: 10.1007/s10096-021-04313-3. Epub 2021 Aug 12.
PMID: 34383175
citation: Collonnaz M, Erpelding ML, Alla F, Goehringer F, Delahaye F, Iung B, Le Moing V, Hoen B, Selton-Suty C, Agrinier N; AEPEI Study Group. Impact of referral bias on prognostic studies outcomes: insights from a population-based cohort study on infective endocarditis. Ann Epidemiol. 2021 Feb;54:29-37. doi: 10.1016/j.annepidem.2020.09.008. Epub 2020 Sep 18.
PMID: 32950657
citation: Collonnaz M, Erpelding ML, Alla F, Goehringer F, Delahaye F, Iung B, Le Moing V, Hoen B, Selton-Suty C, Agrinier N; AEPEI study group. Data on prognostic factors associated with 3-month and 1-year mortality from infective endocarditis. Data Brief. 2020 Nov 1;33:106478. doi: 10.1016/j.dib.2020.106478. eCollection 2020 Dec.
PMID: 33225027
citation: De Ciancio G, Erpelding ML, Filippetti L, Goehringer F, Blangy H, Huttin O, Agrinier N, Juilliere Y, Sadoul N, Selton-Suty C. Adherence to diagnostic and therapeutic practice guidelines for suspected cardiac implantable electronic device infections. Arch Cardiovasc Dis. 2021 Oct;114(10):634-646. doi: 10.1016/j.acvd.2021.06.010. Epub 2021 Nov 3.
PMID: 34742672
citation: Selton-Suty C, Delahaye F, Tattevin P, Federspiel C, Le Moing V, Chirouze C, Nazeyrollas P, Vernet-Garnier V, Bernard Y, Chocron S, Obadia JF, Alla F, Hoen B, Duval X; AEPEI (Association pour l'Etude et la Prevention de l'Endocardite Infectieuse). Symptomatic and Asymptomatic Neurological Complications of Infective Endocarditis: Impact on Surgical Management and Prognosis. PLoS One. 2016 Jul 11;11(7):e0158522. doi: 10.1371/journal.pone.0158522. eCollection 2016.
PMID: 27400273
citation: Radjabaly Mandjee A, Filippetti L, Goehringer F, Duval X, Botelho-Nevers E, Tribouilloy C, Huguet R, Chirouze C, Erpelding ML, Hoen B, Selton-Suty C, Agrinier N, Lefevre B; investigators of the French AEPEI Observatory on Infective Endocarditis (Association pour l'Etude et la Prevention de l'Endocardite Infectieuse). Characteristics of patients with infective endocarditis and no underlying cardiac conditions. Infect Dis (Lond). 2022 Sep;54(9):656-665. doi: 10.1080/23744235.2022.2078404. Epub 2022 May 23.
PMID: 35604065
citation: Beraud G, Tubiana S, Erpelding ML, Le Moing V, Chirouze C, Gorenne I, Manchon P, Tattevin P, Vernet V, Varon E, Hoen B, Duval X; AEPEI study group; COMBAT study group. Combined Bacterial Meningitis and Infective Endocarditis: When Should We Search for the Other When Either One is Diagnosed? Infect Dis Ther. 2022 Aug;11(4):1521-1540. doi: 10.1007/s40121-022-00651-7. Epub 2022 May 26.
PMID: 35618954
citation: Lefevre B, Legoff A, Boutrou M, Goehringer F, Ngueyon-Sime W, Chirouze C, Revest M, Vernet Garnier V, Duval X, Delahaye F, Le Moing V, Selton-Suty C, Filippetti L, Hoen B, Agrinier N. Staphylococcus aureus endocarditis: Identifying prognostic factors using a method derived from morbidity and mortality conferences. Front Med (Lausanne). 2022 Dec 6;9:1053278. doi: 10.3389/fmed.2022.1053278. eCollection 2022.
PMID: 36561723
citation: Fowler VG, Durack DT, Selton-Suty C, Athan E, Bayer AS, Chamis AL, Dahl A, DiBernardo L, Durante-Mangoni E, Duval X, Fortes CQ, Fosbol E, Hannan MM, Hasse B, Hoen B, Karchmer AW, Mestres CA, Petti CA, Pizzi MN, Preston SD, Roque A, Vandenesch F, van der Meer JTM, van der Vaart TW, Miro JM. The 2023 Duke-International Society for Cardiovascular Infectious Diseases Criteria for Infective Endocarditis: Updating the Modified Duke Criteria. Clin Infect Dis. 2023 Aug 22;77(4):518-526. doi: 10.1093/cid/ciad271.
PMID: 37138445
responsible party type: Principal Investigator
investigator affiliation: Central Hospital, Nancy, France
investigator full name: Christine Selton-Suty
investigator title: Dr
mesh term: Endocarditis, Bacterial
mesh term: Endocarditis
sharing ipd: No