<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/NCT03000049</url>
  </required_header>
  <id_info>
    <org_study_id>SD_BK_1_ANI</org_study_id>
    <nct_id>NCT03000049</nct_id>
  </id_info>
  <brief_title>Bedside vs. Standard Microbiological Blood Culture Diagnostics - BEMIDIA Study</brief_title>
  <acronym>BEMIDIA</acronym>
  <official_title>Bedside vs. Standard Microbiological Blood Culture Diagnostics - BEMIDIA Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medicine Greifswald</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medicine Greifswald</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      With a completely bedside blood culture diagnostics system (BACTEC blood culture system in&#xD;
      combination with the Accelerate ID/AST System) it is possible to optimize the initial&#xD;
      antimicrobial therapy in patients with sepsis and septic shock.&#xD;
&#xD;
      Prospective observational, open-label mono-center study to compare a completely bedside blood&#xD;
      culture diagnostics system (BACTEC blood culture system in combination with the Accelerate&#xD;
      ID/AST System and Curetis Univero System) with standard blood culture diagnostics in patients&#xD;
      with sepsis or septic shock.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</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>Time to a significant change of antimicrobial therapy from the time of the diagnosis of sepsis or septic shock</measure>
    <time_frame>Nov. 2016 - Nov. 2017</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Sepsis Septic Shock</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>bedside blood culture</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with sepsis or septic shock with planned blood culture drawing&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a new diagnosed sepsis or septic shock: emergency department, operating&#xD;
             theatre, intensive care unit and planed blood culture diagnostics.&#xD;
&#xD;
          -  informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients (&lt; 18 Years)&#xD;
&#xD;
          -  DNR-order&#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_contact>
    <last_name>Matthias Gründling, MD</last_name>
    <email>gruendli@uni-greifswald.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany</name>
      <address>
        <city>Greifswald</city>
        <zip>17475</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sven-Olaf Kuhn, MD</last_name>
      <phone>3834507952</phone>
      <email>kuhn@uni-greifswald.de</email>
    </contact>
    <contact_backup>
      <last_name>Matthias Gründling, MD</last_name>
    </contact_backup>
    <investigator>
      <last_name>Matthias Gründling, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 21, 2016</last_update_submitted>
  <last_update_submitted_qc>December 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medicine Greifswald</investigator_affiliation>
    <investigator_full_name>Sven-Olaf Kuhn</investigator_full_name>
    <investigator_title>Sven-Olaf Kuhn MD</investigator_title>
  </responsible_party>
  <keyword>sepsis</keyword>
  <keyword>septic shock</keyword>
  <keyword>blood cultures</keyword>
  <keyword>anti-infective therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</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/NCT03000049
org study id: SD_BK_1_ANI
nct id: NCT03000049
lead sponsor: 
has dmc: No
With a completely bedside blood culture diagnostics system (BACTEC blood culture system in
      combination with the Accelerate ID/AST System) it is possible to optimize the initial
      antimicrobial therapy in patients with sepsis and septic shock.

      Prospective observational, open-label mono-center study to compare a completely bedside blood
      culture diagnostics system (BACTEC blood culture system in combination with the Accelerate
      ID/AST System and Curetis Univero System) with standard blood culture diagnostics in patients
      with sepsis or septic shock.
observational model: Cohort
time perspective: Prospective
measure: Time to a significant change of antimicrobial therapy from the time of the diagnosis of sepsis or septic shock
time frame: Nov. 2016 - Nov. 2017
intervention type: Other
intervention name: bedside blood culture
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthias Gründling, MD
email: gruendli@uni-greifswald.de
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Medicine Greifswald
investigator full name: Sven-Olaf Kuhn
investigator title: Sven-Olaf Kuhn MD
mesh term: Shock, Septic
sharing ipd: No