<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/NCT02213783</url>
  </required_header>
  <id_info>
    <org_study_id>IMIFN53-068-11-1-1</org_study_id>
    <nct_id>NCT02213783</nct_id>
  </id_info>
  <brief_title>Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia</brief_title>
  <official_title>Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia Following Administration by 4-hour Infusion and Bolus Injection.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prince of Songkla University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Prince of Songkla University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is prospective and randomized study to compare the pharmacodynamics (t&gt;MIC) of 0.5 g&#xD;
      every 6 h of imipenem in twelve patients with febrile neutropenia following administration by&#xD;
      a 4 h infusion or bolus injection.&#xD;
&#xD;
      Concentration of imipenem in plasma will be measured by HPLC method and simulated in Monte&#xD;
      Carlo technique (Computer model) to get PK/PD index (40%T&gt;MIC) and reported to %PTA&#xD;
      (Probability Target Attainment) and %CFR (Cumulative Faction Response.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>Phase 4</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>Concentration of imipenem in plasma</measure>
    <time_frame>6 hours profile after 8th dose of imipenem</time_frame>
    <description>Concentration of imipenem in plasma will be determined by HPLC method and simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T&gt;MIC) and reported to % PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Patients With Febrile Neutropenia</condition>
  <arm_group>
    <arm_group_label>Conventional arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Infusion of 0.5 g of imipenem for 0.5 hr every 6 hr for 2-5 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Extended infusion arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infusion of 0.5 g of imipenem for 4 hr every 6 hr for 2-5 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Imipenem</intervention_name>
    <description>Each patient will receive 0.5 g of imipenem, 0.5 hr infusion every 6 hr at room temperature</description>
    <arm_group_label>Conventional arm</arm_group_label>
    <other_name>Tienam</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Imipenem</intervention_name>
    <description>Each patient will receive 0.5 g of imipenem, 4 hr infusion every 6 hr of at room temperature</description>
    <arm_group_label>Extended infusion arm</arm_group_label>
    <other_name>Tienam</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged &gt; or = 20 years&#xD;
&#xD;
          -  Patients who have febrile neutropenia with Gram negative bacilli infections which are&#xD;
             sensitive to imipenem by the disk diffusion&#xD;
&#xD;
          -  Patients who are likely to survive 3 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have documented hypersensitivity to imipenem or other carbapenems&#xD;
&#xD;
          -  Patients who have an estimated creatinine clearance of &lt; 50 ml/min&#xD;
&#xD;
          -  Patients who are in circulatory shock or hypotension (systolic &lt; 90 mmHg)&#xD;
&#xD;
          -  Patients who are pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sutep Jaruratanasirikul, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prince of Songkla University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University</name>
      <address>
        <city>Hat Yai</city>
        <state>Songkla</state>
        <zip>90110</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>August 8, 2014</last_update_submitted>
  <last_update_submitted_qc>August 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Prince of Songkla University</investigator_affiliation>
    <investigator_full_name>Sutep Jaruratanasirikul</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Imipenem</keyword>
  <keyword>Febrile neutropenia</keyword>
  <keyword>Gram-negative infection</keyword>
  <keyword>Pharmacodynamic</keyword>
  <keyword>Monte Carlo Simulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neutropenia</mesh_term>
    <mesh_term>Febrile Neutropenia</mesh_term>
    <mesh_term>Hyperthermia</mesh_term>
    <mesh_term>Fever</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Imipenem</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/NCT02213783
org study id: IMIFN53-068-11-1-1
nct id: NCT02213783
lead sponsor: 
collaborator: 
has dmc: No
This is prospective and randomized study to compare the pharmacodynamics (t>MIC) of 0.5 g
      every 6 h of imipenem in twelve patients with febrile neutropenia following administration by
      a 4 h infusion or bolus injection.

      Concentration of imipenem in plasma will be measured by HPLC method and simulated in Monte
      Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and reported to %PTA
      (Probability Target Attainment) and %CFR (Cumulative Faction Response.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Concentration of imipenem in plasma
time frame: 6 hours profile after 8th dose of imipenem
description: Concentration of imipenem in plasma will be determined by HPLC method and simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and reported to % PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response).
arm group label: Conventional arm
arm group type: Active Comparator
description: Infusion of 0.5 g of imipenem for 0.5 hr every 6 hr for 2-5 days
arm group label: Extended infusion arm
arm group type: Experimental
description: Infusion of 0.5 g of imipenem for 4 hr every 6 hr for 2-5 days
intervention type: Drug
intervention name: Imipenem
description: Each patient will receive 0.5 g of imipenem, 0.5 hr infusion every 6 hr at room temperature
arm group label: Conventional arm
other name: Tienam
intervention type: Drug
intervention name: Imipenem
description: Each patient will receive 0.5 g of imipenem, 4 hr infusion every 6 hr of at room temperature
arm group label: Extended infusion arm
other name: Tienam
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
last name: Sutep Jaruratanasirikul, M.D.
role: Principal Investigator
affiliation: Prince of Songkla University
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Prince of Songkla University
investigator full name: Sutep Jaruratanasirikul
investigator title: Principal Investigator
mesh term: Neutropenia
mesh term: Febrile Neutropenia
mesh term: Hyperthermia
mesh term: Fever
mesh term: Imipenem