<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/NCT04429256</url>
  </required_header>
  <id_info>
    <org_study_id>Req-2020-00373;ch20Reuthebuch2</org_study_id>
    <nct_id>NCT04429256</nct_id>
  </id_info>
  <brief_title>Prosthetic Valve and Graft Endocarditis With Mycobacterium Chimaera</brief_title>
  <official_title>Prosthetic Valve and Graft Endocarditis With Mycobacterium Chimaera: Diagnosis, Course of Disease, and Therapy Recommendations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      Mycobacterium chimaera infections have occurred in post-cardiac surgery patients in&#xD;
      association with contaminated cardiac bypass heater-cooler devices.&#xD;
&#xD;
      So far optimal therapeutical concepts are not clear. At the University Hospital Basel&#xD;
      Mycobacterium chimaera- infected protheses are replaced to decrease pathogenic burden and to&#xD;
      support antibiotic long- term treatment. This study is to analyze the efficacy of this&#xD;
      therapeutic approach.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 10, 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>summary of disease course in patients with Mycobacterium chimaera- infections after cardiac surgery</measure>
    <time_frame>at baseline</time_frame>
    <description>Descriptive statistical analysis of disease course in patients with Mycobacterium chimaera- infections after cardiac surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>summary of therapeutic interventions in patients with Mycobacterium chimaera- infections after cardiac surgery</measure>
    <time_frame>at baseline</time_frame>
    <description>Descriptive statistical analysis of therapeutic interventions in patients with Mycobacterium chimaera- infections after cardiac surgery</description>
  </primary_outcome>
  <enrollment type="Actual">7</enrollment>
  <condition>Mycobacterium Chimaera Infections</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>data collection</intervention_name>
    <description>retrospective analysis of perioperative data collected from patient medical charts and from a telephone enquiry</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Mycobacterium chimaera infections after cardiac surgery at University&#xD;
        Hospital Basel&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Mycobacterium chimaera infections after cardiac surgery at University&#xD;
             Hospital Basel&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Oliver Reuthebuch, Prof. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiac Surgery Clinic University Hospital Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardiac Surgery Clinic University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>August 17, 2021</last_update_submitted>
  <last_update_submitted_qc>August 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cardiac bypass heater-cooler devices</keyword>
  <keyword>cardiac surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycobacterium Infections</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/NCT04429256
org study id: Req-2020-00373;ch20Reuthebuch2
nct id: NCT04429256
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Mycobacterium chimaera infections have occurred in post-cardiac surgery patients in
      association with contaminated cardiac bypass heater-cooler devices.

      So far optimal therapeutical concepts are not clear. At the University Hospital Basel
      Mycobacterium chimaera- infected protheses are replaced to decrease pathogenic burden and to
      support antibiotic long- term treatment. This study is to analyze the efficacy of this
      therapeutic approach.
observational model: Cohort
time perspective: Retrospective
measure: summary of disease course in patients with Mycobacterium chimaera- infections after cardiac surgery
time frame: at baseline
description: Descriptive statistical analysis of disease course in patients with Mycobacterium chimaera- infections after cardiac surgery
measure: summary of therapeutic interventions in patients with Mycobacterium chimaera- infections after cardiac surgery
time frame: at baseline
description: Descriptive statistical analysis of therapeutic interventions in patients with Mycobacterium chimaera- infections after cardiac surgery
intervention type: Other
intervention name: data collection
description: retrospective analysis of perioperative data collected from patient medical charts and from a telephone enquiry
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Oliver Reuthebuch, Prof. Dr. med.
role: Principal Investigator
affiliation: Cardiac Surgery Clinic University Hospital Basel
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Mycobacterium Infections
mesh term: Endocarditis