xml: <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/NCT05989152</url>
    </required_header>
    <id_info>
      <org_study_id>APHP230123</org_study_id>
      <secondary_id>2022-A02782-41</secondary_id>
      <nct_id>NCT05989152</nct_id>
    </id_info>
    <brief_title>Evolution of PET Fixation With FDG at the End of Antibiotic Treatment of Infective Endocarditis on Valvular Prosthesis</brief_title>
    <acronym>EndEOTEP</acronym>
    <official_title>Evolution of Positron Emission Computed Tomography (PET) Fixation With Fluorodeoxyglucose (FDG) at the End of Antibiotic Treatment of Infective Endocarditis on Valvular Prosthesis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</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>
        In patients with prosthetic valve endocarditis (PVE) and pathological valvular FDG uptake on&#xD;
        the initial FDG-PET and not referred to valve replacement at the acute phase, the study will&#xD;
        assess whether FDG-PET is able to identify those at increased risk of PVE relapse.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In patients medically treated for prosthetic valve infection (PVE), identification of&#xD;
        persistent infection or of cure could be very useful to 1/ patients referral to high-risk&#xD;
        surgery, 2/ initiation of suppressive antibiotic therapy, or 3/ simplify the follow-up in&#xD;
        other patients. The hypothesis is that FDG-PET could thus identify patients at increased risk&#xD;
        of recurrence in case of persistent pathological uptake In patients with prosthetic&#xD;
        endocarditis and pathological valvular FDG uptake on the initial FDG-PET and not referred to&#xD;
        valve replacement at the acute phase, the main objective is to estimate the proportion of&#xD;
        those still showing pathological valvular FDG uptake after curative antibiotic treatment. The&#xD;
        secondary objectives are 1/ to quantitatively compare the valvular FDG-PET uptake for each&#xD;
        individual before and after treatment; 2/ to determine the proportion of those in whom&#xD;
        extracardiac foci persist at the end of treatment ; 3/ to evaluate the association between&#xD;
        valvular FDG uptake on PET at the end of treatment and PVE relapse at 6 months; 4/ to&#xD;
        evaluate the diagnostic performance of an automatic analysis by artificial intelligence of&#xD;
        FDG uptake before and after treatment to predict PVE relapse at 6 months.&#xD;
  &#xD;
        This is a single-center prospective cohort study. The population is composed of 50 adults&#xD;
        with definite PVE according to the ESC 2015 classification, not operated in the acute phase&#xD;
        and with pathological FDG-PET at the beginning of curative antibiotic treatment.&#xD;
  &#xD;
        A change in practices regarding the duration of antibiotic therapy and the use of valve&#xD;
        replacement surgery and its potential complications would benefit patients and reduce the&#xD;
        overall cost related to valve prosthesis infection to the healthcare system.&quot;&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Presence of pathological uptake on the prosthetic valve on FDG-PET</measure>
      <time_frame>at inclusion</time_frame>
      <description>Presence of pathological uptake on the prosthetic valve on FDG-PET performed after the recommended duration of curative antibiotic treatment</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evolution of the FDG uptake intensity on the prosthetic valve by FDG-PET</measure>
      <time_frame>at inclusion</time_frame>
      <description>by comparing the FDG uptake intensity on the prosthetic valve between initial and at the end of curative antibiotic treatment FDG-PET</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Presence of the intensity of extracardiac uptake on the FDG-PET at the end of curative antibiotic treatment in patients presenting with pathological extracardiac uptake on the initial FDG-PET</measure>
      <time_frame>at inclusion</time_frame>
      <description>by comparing the intensity of extracardiac uptake between FDG-PET initial and at the end of curative antibiotic treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of the intensity of extracardiac uptake on the FDG-PET at the end of curative antibiotic treatment in patients presenting with pathological extracardiac uptake on the initial FDG-PET</measure>
      <time_frame>at inclusion</time_frame>
      <description>by comparing the intensity of extracardiac uptake between FDG-PET initial and at the end of curative antibiotic treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relapse of endocarditis defined by the same location and the same microorganism within 6 months</measure>
      <time_frame>6 month</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Therapeutic impact of end-of-treatment PET-FDG measured by stopping or continuing antibiotic treatment</measure>
      <time_frame>6 month</time_frame>
      <description>measured by stopping or continuing antibiotic treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diagnostic performance of AI to predict relapse of endocarditis defined by the same location and the same microorganism within 6 months</measure>
      <time_frame>6 month</time_frame>
      <description>classification</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Prosthetic Valve Endocarditis</condition>
    <arm_group>
      <arm_group_label>Definite prosthetic valve endocarditis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>adult patients with a valvular prosthesis presenting a definite infective endocarditis (IE) according to the ESC classification in force, not operated on in the acute phase (before the PET scan at the end of treatment) and presenting a pathological FDG uptake on the prosthetic valve at the start of curative antibiotic treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>FDG-PET at the end of treatment for IE</intervention_name>
      <description>FDG-PET at the end of treatment for IE in patients with a prosthetic valve</description>
      <arm_group_label>Definite prosthetic valve endocarditis</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          &quot;Inclusion criteria:&#xD;
  &#xD;
            -  Patient aged 18 or over;&#xD;
  &#xD;
            -  Wearer of a valvular prosthesis (implanted surgically or by catheter);&#xD;
  &#xD;
            -  Presenting a definite IE on a valvular prosthesis (ESC definition in force);&#xD;
  &#xD;
            -  Abnormal FDG-PET scan for diagnostic purposes at the site of the valvular prosthesis;&#xD;
  &#xD;
            -  Not operated at in the acute phase (before the PET scan at the end of treatment)&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Patient under legal protection, guardianship or curators;&#xD;
  &#xD;
            -  Pregnancy, breastfeeding;&#xD;
  &#xD;
            -  Patient not affiliated to a health insurance scheme or not a beneficiary of a social&#xD;
               security scheme;&#xD;
  &#xD;
            -  Simultaneous participation in a study on FDG-PET;&#xD;
  &#xD;
            -  Absence of informed consent signed by the patient.&quot;&#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>François Rouzet, MD, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>François Rouzet, MD, PHD</last_name>
      <phone>01.40.25.64.11</phone>
      <phone_ext>33</phone_ext>
      <email>francois.rouzet@aphp.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xavier Duval, MD, PHD</last_name>
      <email>xavier.duval@aphp.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hôpital Bichat-Claude Bernard</name>
        <address>
          <city>Paris</city>
          <zip>75018</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>François Rouzet, MD, PHD</last_name>
        <phone>01.40.25.64.11</phone>
        <phone_ext>33</phone_ext>
        <email>francois.rouzet@aphp.fr</email>
      </contact>
      <contact_backup>
        <last_name>Xavier Duval, MD, PHD</last_name>
        <email>xavier.duval@aphp.fr</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Infective endocarditis</keyword>
    <keyword>end of treatment</keyword>
    <keyword>Positron emission tomography</keyword>
    <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>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989152
  org study id: APHP230123
  secondary id: 2022-A02782-41
  nct id: NCT05989152
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In patients with prosthetic valve endocarditis (PVE) and pathological valvular FDG uptake on
        the initial FDG-PET and not referred to valve replacement at the acute phase, the study will
        assess whether FDG-PET is able to identify those at increased risk of PVE relapse.
  In patients medically treated for prosthetic valve infection (PVE), identification of
        persistent infection or of cure could be very useful to 1/ patients referral to high-risk
        surgery, 2/ initiation of suppressive antibiotic therapy, or 3/ simplify the follow-up in
        other patients. The hypothesis is that FDG-PET could thus identify patients at increased risk
        of recurrence in case of persistent pathological uptake In patients with prosthetic
        endocarditis and pathological valvular FDG uptake on the initial FDG-PET and not referred to
        valve replacement at the acute phase, the main objective is to estimate the proportion of
        those still showing pathological valvular FDG uptake after curative antibiotic treatment. The
        secondary objectives are 1/ to quantitatively compare the valvular FDG-PET uptake for each
        individual before and after treatment; 2/ to determine the proportion of those in whom
        extracardiac foci persist at the end of treatment ; 3/ to evaluate the association between
        valvular FDG uptake on PET at the end of treatment and PVE relapse at 6 months; 4/ to
        evaluate the diagnostic performance of an automatic analysis by artificial intelligence of
        FDG uptake before and after treatment to predict PVE relapse at 6 months.
  
        This is a single-center prospective cohort study. The population is composed of 50 adults
        with definite PVE according to the ESC 2015 classification, not operated in the acute phase
        and with pathological FDG-PET at the beginning of curative antibiotic treatment.
  
        A change in practices regarding the duration of antibiotic therapy and the use of valve
        replacement surgery and its potential complications would benefit patients and reduce the
        overall cost related to valve prosthesis infection to the healthcare system."
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Presence of pathological uptake on the prosthetic valve on FDG-PET
  time frame: at inclusion
  description: Presence of pathological uptake on the prosthetic valve on FDG-PET performed after the recommended duration of curative antibiotic treatment
  measure: Evolution of the FDG uptake intensity on the prosthetic valve by FDG-PET
  time frame: at inclusion
  description: by comparing the FDG uptake intensity on the prosthetic valve between initial and at the end of curative antibiotic treatment FDG-PET
  measure: Presence of the intensity of extracardiac uptake on the FDG-PET at the end of curative antibiotic treatment in patients presenting with pathological extracardiac uptake on the initial FDG-PET
  time frame: at inclusion
  description: by comparing the intensity of extracardiac uptake between FDG-PET initial and at the end of curative antibiotic treatment
  measure: Evolution of the intensity of extracardiac uptake on the FDG-PET at the end of curative antibiotic treatment in patients presenting with pathological extracardiac uptake on the initial FDG-PET
  time frame: at inclusion
  description: by comparing the intensity of extracardiac uptake between FDG-PET initial and at the end of curative antibiotic treatment
  measure: Relapse of endocarditis defined by the same location and the same microorganism within 6 months
  time frame: 6 month
  measure: Therapeutic impact of end-of-treatment PET-FDG measured by stopping or continuing antibiotic treatment
  time frame: 6 month
  description: measured by stopping or continuing antibiotic treatment
  measure: Diagnostic performance of AI to predict relapse of endocarditis defined by the same location and the same microorganism within 6 months
  time frame: 6 month
  description: classification
  arm group label: Definite prosthetic valve endocarditis
  arm group type: Experimental
  description: adult patients with a valvular prosthesis presenting a definite infective endocarditis (IE) according to the ESC classification in force, not operated on in the acute phase (before the PET scan at the end of treatment) and presenting a pathological FDG uptake on the prosthetic valve at the start of curative antibiotic treatment.
  intervention type: Radiation
  intervention name: FDG-PET at the end of treatment for IE
  description: FDG-PET at the end of treatment for IE in patients with a prosthetic valve
  arm group label: Definite prosthetic valve endocarditis
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: François Rouzet, MD, PHD
  role: Principal Investigator
  affiliation: Assistance Publique - Hôpitaux de Paris
  last name: François Rouzet, MD, PHD
  phone: 01.40.25.64.11
  phone ext: 33
  email: francois.rouzet@aphp.fr
  last name: Xavier Duval, MD, PHD
  email: xavier.duval@aphp.fr
  facility: 
  contact: 
  contact backup: 
  country: France
  responsible party type: Sponsor
  mesh term: Endocarditis, Bacterial
  mesh term: Endocarditis
  sharing ipd: Undecided