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/NCT05983341</url>
    </required_header>
    <id_info>
      <org_study_id>69HCL23_0790</org_study_id>
      <nct_id>NCT05983341</nct_id>
    </id_info>
    <brief_title>Complications in Pediatric Mechanical Circulatory Assistance: Evaluation of Infection Management.</brief_title>
    <acronym>VADINFECT</acronym>
    <official_title>Relapse of VAD Infections After Discontinuation of Anti-infective Therapies in Children.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospices Civils de Lyon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospices Civils de Lyon</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>
        End-stage heart failure in children is a rare cause of infant mortality. The most frequent&#xD;
        cause is dilated cardiomyopathy, often of undetermined origin, which can lead to cardiogenic&#xD;
        shock refractory to standard medical treatment. In such cases, it is essential to resort to&#xD;
        exceptional means, available at tertiary care hospitals such as in Lyon. The therapeutic&#xD;
        means includes long-term circulatory assistance (VAD). This type of circulatory assistance is&#xD;
        becoming increasingly used in view of the shortage of heart transplants. Indeed, the average&#xD;
        waiting time on the paediatric transplant list varies from 3 months to over a year for&#xD;
        children under 5. Berlin Heart EXCOR (BHE) is the only long-term support available for&#xD;
        children (2). It is a pulsatile para-corporeal assisting device with percutaneous cannulas.&#xD;
  &#xD;
        Despite technical and medical advances in circulatory support, the presence of foreign&#xD;
        material is frequently complicated by infection. Infection is a major cause of morbidity and&#xD;
        mortality in this population. It is most often of nosocomial origin, linked to central line&#xD;
        infections. The germs associated with these infections are mainly bacteria, with a small&#xD;
        proportion of fungi. The most common pathogens are multi-resistant gram-positive bacteria,&#xD;
        which colonize the skin, adhere to the implanted equipment and create biofilms. Infections&#xD;
        have a major impact on the morbidity and mortality of patients undergoing mechanical&#xD;
        assistance, with an increased risk of thrombo-embolic events and difficulty in managing&#xD;
        anticoagulation, secondary to inflammation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        There are few literatures on the management of infections under mechanical assistance.&#xD;
        Current ISHLT (International Society for Heart and Lung Transplantation) recommendations are&#xD;
        based on expert opinion and observational studies. Actual recommendations are long-term&#xD;
        anti-infective therapy, even up to the time of transplantation in the case of&#xD;
        assistance-specific or assistance-associated infections.&#xD;
  &#xD;
        At the Hospices Civils de Lyon, BH-assisted patients awaiting transplantation are cared for&#xD;
        in the paediatric cardiac intensive care unit (PCICU). Infections are managed jointly with&#xD;
        the infectious diseases team, through weekly consultations and RCP. The management strategy&#xD;
        is directed towards the rational use of antibiotics and antifungals, to limit the impact of&#xD;
        broad-spectrum, long-term antibiotic therapy on the microbiological environment and on the&#xD;
        patient. The duration of anti-infective therapy is limited on the basis of clinical and&#xD;
        biological criteria. In some cases, recurrence of the infectious episode may occur.&#xD;
  &#xD;
        This study will provide information on the therapeutic strategy for VAD infections.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2023</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>Relapse of infection defined as an infection with an identical from a previous infectious episode germ (microbiological characterization and similar resistance profile).</measure>
      <time_frame>From time of Berlin Heart EXCOR implantation to up to 6 months after heart transplantation.</time_frame>
      <description>Clinical and microbiological diagnosis of a relapse of infection with the same germ after discontinuation of anti-infective therapy in the context of a specific or assistance-related infection</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Heart Failure</condition>
    <condition>Implant Infection</condition>
    <arm_group>
      <arm_group_label>Children (&lt;18 years old) with Berlin Heart EXCOR assisting device.</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Heart failure pediatric patients in need of ventricular assisting device&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          -  Inclusion Criteria * :&#xD;
  &#xD;
                 -  Age &lt; 18years old&#xD;
  &#xD;
                 -  Berlin Heart EXCOR implantation&#xD;
  &#xD;
            -  Exclusion Criteria * :&#xD;
  &#xD;
                 -  None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Hôpital Femme Mere eEnfant</name>
        <address>
          <city>Bron</city>
          <state>Rhone Alpes</state>
          <zip>69500</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Berlin Heart EXCOR</keyword>
    <keyword>pediatric</keyword>
    <keyword>VAD infections</keyword>
    <keyword>Heart Failure</keyword>
    <keyword>implanted material infection.</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <!-- 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/NCT05983341
  org study id: 69HCL23_0790
  nct id: NCT05983341
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  End-stage heart failure in children is a rare cause of infant mortality. The most frequent
        cause is dilated cardiomyopathy, often of undetermined origin, which can lead to cardiogenic
        shock refractory to standard medical treatment. In such cases, it is essential to resort to
        exceptional means, available at tertiary care hospitals such as in Lyon. The therapeutic
        means includes long-term circulatory assistance (VAD). This type of circulatory assistance is
        becoming increasingly used in view of the shortage of heart transplants. Indeed, the average
        waiting time on the paediatric transplant list varies from 3 months to over a year for
        children under 5. Berlin Heart EXCOR (BHE) is the only long-term support available for
        children (2). It is a pulsatile para-corporeal assisting device with percutaneous cannulas.
  
        Despite technical and medical advances in circulatory support, the presence of foreign
        material is frequently complicated by infection. Infection is a major cause of morbidity and
        mortality in this population. It is most often of nosocomial origin, linked to central line
        infections. The germs associated with these infections are mainly bacteria, with a small
        proportion of fungi. The most common pathogens are multi-resistant gram-positive bacteria,
        which colonize the skin, adhere to the implanted equipment and create biofilms. Infections
        have a major impact on the morbidity and mortality of patients undergoing mechanical
        assistance, with an increased risk of thrombo-embolic events and difficulty in managing
        anticoagulation, secondary to inflammation.
  There are few literatures on the management of infections under mechanical assistance.
        Current ISHLT (International Society for Heart and Lung Transplantation) recommendations are
        based on expert opinion and observational studies. Actual recommendations are long-term
        anti-infective therapy, even up to the time of transplantation in the case of
        assistance-specific or assistance-associated infections.
  
        At the Hospices Civils de Lyon, BH-assisted patients awaiting transplantation are cared for
        in the paediatric cardiac intensive care unit (PCICU). Infections are managed jointly with
        the infectious diseases team, through weekly consultations and RCP. The management strategy
        is directed towards the rational use of antibiotics and antifungals, to limit the impact of
        broad-spectrum, long-term antibiotic therapy on the microbiological environment and on the
        patient. The duration of anti-infective therapy is limited on the basis of clinical and
        biological criteria. In some cases, recurrence of the infectious episode may occur.
  
        This study will provide information on the therapeutic strategy for VAD infections.
  observational model: Cohort
  time perspective: Retrospective
  measure: Relapse of infection defined as an infection with an identical from a previous infectious episode germ (microbiological characterization and similar resistance profile).
  time frame: From time of Berlin Heart EXCOR implantation to up to 6 months after heart transplantation.
  description: Clinical and microbiological diagnosis of a relapse of infection with the same germ after discontinuation of anti-infective therapy in the context of a specific or assistance-related infection
  arm group label: Children (<18 years old) with Berlin Heart EXCOR assisting device.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 18 Years
  healthy volunteers: No
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Heart Failure