<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/NCT03007290</url>
  </required_header>
  <id_info>
    <org_study_id>Colistin_TDM</org_study_id>
    <nct_id>NCT03007290</nct_id>
  </id_info>
  <brief_title>Clinical Usefulness of Therapeutic Drug Monitoring of Colistin in Patients Treated With Colistin.</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical usefulness of therapeutic drug monitoring of colistin in patients treated with&#xD;
      colistin&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AKI</measure>
    <time_frame>Through study completion, an average of 1 month</time_frame>
    <description>Emergence rate of acute kidney injury</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>Through study completion, an average of 1 month</time_frame>
    <description>Death rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative conversion rate</measure>
    <time_frame>Through study completion, an average of 1 month</time_frame>
    <description>Culture-negative conversion rate Treatment success Treatment success</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Multidrug-resistant Gram-negative Bacteria Infection</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group with therapeutic drug monitoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Therapeutic drug monitoring</intervention_name>
    <description>Therapeutic drug monitoring for colistin</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18 years old.&#xD;
&#xD;
          -  Those who receive colistin therapy for the treatment of multi-drug resistant gram&#xD;
             negative bacteria infection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who received colistin therapy less than 48 hours&#xD;
&#xD;
          -  Those who received colistin therapy through the bronchus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>April 16, 2018</last_update_submitted>
  <last_update_submitted_qc>April 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Eu Suk Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gram-Negative Bacterial Infections</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/NCT03007290
org study id: Colistin_TDM
nct id: NCT03007290
lead sponsor: 
has dmc: No
Clinical usefulness of therapeutic drug monitoring of colistin in patients treated with
      colistin
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: AKI
time frame: Through study completion, an average of 1 month
description: Emergence rate of acute kidney injury
measure: Death
time frame: Through study completion, an average of 1 month
description: Death rate
measure: Negative conversion rate
time frame: Through study completion, an average of 1 month
description: Culture-negative conversion rate Treatment success Treatment success
arm group label: Treatment group
arm group type: Experimental
description: Group with therapeutic drug monitoring
intervention type: Other
intervention name: Therapeutic drug monitoring
description: Therapeutic drug monitoring for colistin
arm group label: Treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Eu Suk Kim
investigator title: Professor
mesh term: Gram-Negative Bacterial Infections
sharing ipd: No