<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/NCT02241941</url>
  </required_header>
  <id_info>
    <org_study_id>Dapto-ICU-09</org_study_id>
    <secondary_id>EK-1748</secondary_id>
    <nct_id>NCT02241941</nct_id>
  </id_info>
  <brief_title>Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury</brief_title>
  <official_title>Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine single dose pharmacokinetics of daptomycin&#xD;
      consecutively in 10 patients on three different time points after severe burn injury.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Assessment of daptomycin concentrations with microdialysis technically not feasible&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>Phase 4</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic parameters of daptomycin</measure>
    <time_frame>up to 30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of daptomycin plasma concentrations with tissue concentration</measure>
    <time_frame>up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>degree of variability of daptomycin pk parameters in dependency of body surface area burned</measure>
    <time_frame>up to 30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Burn Injury</condition>
  <arm_group>
    <arm_group_label>Daptomycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daptomycin</intervention_name>
    <arm_group_label>Daptomycin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female of 18 years or older&#xD;
&#xD;
          -  Second and/or third degree thermal injury&#xD;
&#xD;
          -  Total body surface area burned ≥ 15%&#xD;
&#xD;
          -  Hospitalisation in the ICU for burn injured patients of the University Hospital Zürich&#xD;
&#xD;
          -  Probability of ICU stay of &gt;14 days&#xD;
&#xD;
          -  Written informed consent by the patient or in patients unable to be informed or to&#xD;
             sign according to section 4.4 of the study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of renal failure (Creatinine clearance &lt;30ml/min) or continuous renal&#xD;
             replacement therapy such as continuous hemofiltration&#xD;
&#xD;
          -  History of muscle disease or skeletal muscle disorder&#xD;
&#xD;
          -  Creatine-phosphokinase (CPK) ≥ 5 times the upper limit of normal (ULN)&#xD;
&#xD;
          -  History of hypersensitivity to the drug&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Severe coagulation disorder&#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>Rainer Weber, MD Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Infectious Diseases and Hospital Epidemiology, Universitit Hospital Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 13, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>October 27, 2016</last_update_submitted>
  <last_update_submitted_qc>October 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Daptomycin</mesh_term>
  </intervention_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/NCT02241941
org study id: Dapto-ICU-09
secondary id: EK-1748
nct id: NCT02241941
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine single dose pharmacokinetics of daptomycin
      consecutively in 10 patients on three different time points after severe burn injury.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Pharmacokinetic parameters of daptomycin
time frame: up to 30 days
measure: Correlation of daptomycin plasma concentrations with tissue concentration
time frame: up to 30 days
measure: degree of variability of daptomycin pk parameters in dependency of body surface area burned
time frame: up to 30 days
arm group label: Daptomycin
arm group type: Experimental
intervention type: Drug
intervention name: Daptomycin
arm group label: Daptomycin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rainer Weber, MD Professor
role: Principal Investigator
affiliation: Division of Infectious Diseases and Hospital Epidemiology, Universitit Hospital Zurich
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Wounds and Injuries
mesh term: Daptomycin