<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/NCT03004066</url>
  </required_header>
  <id_info>
    <org_study_id>Dapto</org_study_id>
    <nct_id>NCT03004066</nct_id>
  </id_info>
  <brief_title>Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients</brief_title>
  <official_title>Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      10 patients with chronic heart failure receiving daptomycin therapy after implantation of a&#xD;
      left ventricular heart assist system. Measurement of daptomycin levels in drainage fluids&#xD;
      (mediastinal and pleural drainage systems) and in blood samples.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</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>levels of Daptomycin in drainage fluid</measure>
    <time_frame>4 days</time_frame>
    <description>Pharmacokinetics of Daptomycin in intensive care patients with wound drainage after surgery (LVAD implantation)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>levels of Daptomycin in blood samples</measure>
    <time_frame>4 days</time_frame>
    <description>Pharmacokinetics of Daptomycin in intensive care patients after surgery (LVAD implantation)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>infections</measure>
    <time_frame>14 days</time_frame>
    <description>incidence of gram-positive infections</description>
  </secondary_outcome>
  <enrollment type="Actual">9</enrollment>
  <condition>Heart Assist Device</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daptomycin</intervention_name>
    <description>standard care</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients after heart assist device implantation with wound drainage receiving daptomycin&#xD;
        therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written consent&#xD;
&#xD;
          -  heart assist device implantation&#xD;
&#xD;
          -  wound drainage&#xD;
&#xD;
          -  daptomycin therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  no written consent possible&#xD;
&#xD;
          -  absence of wound drainage&#xD;
&#xD;
          -  allergy to study medication&#xD;
&#xD;
          -  acute rhabdomyolysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefanie Prohaska, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Tuebingen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Tuebingen</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>April 18, 2019</last_update_submitted>
  <last_update_submitted_qc>April 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Daptomycin</mesh_term>
  </intervention_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/NCT03004066
org study id: Dapto
nct id: NCT03004066
lead sponsor: 
has dmc: No
10 patients with chronic heart failure receiving daptomycin therapy after implantation of a
      left ventricular heart assist system. Measurement of daptomycin levels in drainage fluids
      (mediastinal and pleural drainage systems) and in blood samples.
observational model: Cohort
time perspective: Prospective
measure: levels of Daptomycin in drainage fluid
time frame: 4 days
description: Pharmacokinetics of Daptomycin in intensive care patients with wound drainage after surgery (LVAD implantation)
measure: levels of Daptomycin in blood samples
time frame: 4 days
description: Pharmacokinetics of Daptomycin in intensive care patients after surgery (LVAD implantation)
measure: infections
time frame: 14 days
description: incidence of gram-positive infections
intervention type: Drug
intervention name: Daptomycin
description: standard care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Stefanie Prohaska, MD
role: Principal Investigator
affiliation: University Hospital Tuebingen
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Daptomycin
sharing ipd: No