<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/NCT02202941</url>
  </required_header>
  <id_info>
    <org_study_id>PRODA-2014</org_study_id>
    <nct_id>NCT02202941</nct_id>
  </id_info>
  <brief_title>Procalcitonin-guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients</brief_title>
  <acronym>PRODA</acronym>
  <official_title>Effect of Procalcitonin-guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients in Korea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Evidence-based healthcare Collaborating Agency (NECA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Severance Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial is aimed to show a procalcitonin-guided treatment algorithm may shorten&#xD;
      duration of antibiotic therapy safely and cost-effectively in sepsis patients of Korean ICU.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of antibiotic treatment</measure>
    <time_frame>up to 28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical response to treatment for infection</measure>
    <time_frame>up to 28 days</time_frame>
    <description>success vs failure vs relapse after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In ICU mortality</measure>
    <time_frame>up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In hospital mortality</measure>
    <time_frame>up to 90 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>Procalcitonin guided treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who will be randomized to this arm will receive antibiotics therapy based on procalcitonin-guided algorithm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who will be randomized to this arm will receive antibiotic therapy based on conventional practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Procalcitonin guided treatment</intervention_name>
    <description>Patients who will be randomized to arm will receive antibiotics therapy based on procalcitonin measurement on day 1, 3, 5, 7, 9, 11 and 13.</description>
    <arm_group_label>Procalcitonin guided treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional treatment</intervention_name>
    <description>Patients who will be randomized to this arm will receive antibiotic therapy based on conventional practice.</description>
    <arm_group_label>Conventional treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with suspicious or confirmed sepsis at admission or during stay in ICU&#xD;
&#xD;
          -  Patients with antibiotic duration of less than 48 hours before enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than or equal to 18 years&#xD;
&#xD;
          -  Known pregnancy&#xD;
&#xD;
          -  Specific infections for which long-term antibiotic treatment for 3 weeks more is&#xD;
             strongly recommended: infective endocarditis, empyema, osteomyelitis et al.&#xD;
&#xD;
          -  severe immunocompromised patients : HIV infected patients (CD4 count &lt; 200 cells/mm3),&#xD;
             Neutropenia (ANC count &lt; 500/mm3)&#xD;
&#xD;
          -  Presence of do-not-resuscitate order&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sang-Min Lee, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>November 1, 2018</last_update_submitted>
  <last_update_submitted_qc>November 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Sang-Min Lee</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT02202941
org study id: PRODA-2014
nct id: NCT02202941
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This clinical trial is aimed to show a procalcitonin-guided treatment algorithm may shorten
      duration of antibiotic therapy safely and cost-effectively in sepsis patients of Korean ICU.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Duration of antibiotic treatment
time frame: up to 28 days
measure: Clinical response to treatment for infection
time frame: up to 28 days
description: success vs failure vs relapse after treatment
measure: In ICU mortality
time frame: up to 28 days
measure: All cause mortality
time frame: up to 28 days
measure: In hospital mortality
time frame: up to 90 days
arm group label: Procalcitonin guided treatment
arm group type: Experimental
description: Patients who will be randomized to this arm will receive antibiotics therapy based on procalcitonin-guided algorithm.
arm group label: Conventional treatment
arm group type: Active Comparator
description: Patients who will be randomized to this arm will receive antibiotic therapy based on conventional practice.
intervention type: Other
intervention name: Procalcitonin guided treatment
description: Patients who will be randomized to arm will receive antibiotics therapy based on procalcitonin measurement on day 1, 3, 5, 7, 9, 11 and 13.
arm group label: Procalcitonin guided treatment
intervention type: Other
intervention name: Conventional treatment
description: Patients who will be randomized to this arm will receive antibiotic therapy based on conventional practice.
arm group label: Conventional treatment
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Sang-Min Lee, M.D.
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Sang-Min Lee
investigator title: Associate professor