<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/NCT01706562</url>
  </required_header>
  <id_info>
    <org_study_id>CR017839</org_study_id>
    <secondary_id>ITRFUN4055</secondary_id>
    <secondary_id>ITR-KOR-5088</secondary_id>
    <nct_id>NCT01706562</nct_id>
  </id_info>
  <brief_title>A Study of Empirical Antifungal Therapy With Itraconazole</brief_title>
  <official_title>Retrospective Observation of Empirical Antifungal Therapy With Itraconazole</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Korea, Ltd., Korea</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Korea, Ltd., Korea</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the overall success rate of itraconazole&#xD;
      intravenous treatment for a period of more than 7 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a retrospective study ie, a study that looks backward in time, usually using medical&#xD;
      records and interviews with patients who are already known to have a disease, in patients&#xD;
      with itraconazole intravenous prescription as an empirical (based on practical experience)&#xD;
      antifungal agent. This study collects baseline information about underlying disease, sign of&#xD;
      fungal infection, neutropenia (a decrease in white blood cells), neutropenic fever duration&#xD;
      and the reason for discontinuation. Neutropenia is defined as a neutrophil (white blood cell)&#xD;
      count of ≤500 cells/mm3 or a count of ≤1000 cells/mm3 with a predicted decrease to ≤500&#xD;
      cells/mm3. Fever is defined as a body temperature ≥38.3 Celsius degrees at least once a day&#xD;
      with no definite external factor or a body temperature of ≥38 Celsius degrees continued for&#xD;
      at least 1 hour.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">September 2011</completion_date>
  <primary_completion_date type="Actual">September 2011</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Success rate of itraconazole treatment when used for more than 7 days</measure>
    <time_frame>From 7 days to approximately 2 weeks</time_frame>
    <description>Treatment success is achieved when neutropenia is resolved, ie, when the blood cells count is within the normal reference range.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Success rate of itraconazole treatment until neutropenia is resolved</measure>
    <time_frame>Approximately 2 weeks</time_frame>
    <description>Treatment success is achieved when neutropenia is resolved, ie, when the blood cells count is within the normal reference range.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drop out rate due to the lack of efficacy of itraconazole treatment</measure>
    <time_frame>Approximately 2 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">138</enrollment>
  <condition>Neutropenia</condition>
  <arm_group>
    <arm_group_label>Itraconazole</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Itraconazole</intervention_name>
    <description>Itraconazole intravenous (IV) 200 mg twice daily for 2 days, a total of 4 doses and then 200 mg once daily until clinically significant resolution of neutropenia.</description>
    <arm_group_label>Itraconazole</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study population consists of patients with hematologic malignancy who visited a study&#xD;
        center and were treated with itraconazole intravenous (IV) for more than 7 days.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with neutropenic fever who receive therapy for inhibiting or preventing&#xD;
             development of neoplasms (abnormal growth of tissue) or stem cell transplantation&#xD;
             (stem cell is a cell whose daughter cells may differentiate into other cell types) for&#xD;
             hematologic malignancies (cancers that affect blood, bone marrow and lymph nodes)&#xD;
&#xD;
          -  Patients who receive itraconazole intravenous (IV) treatment for more than 7 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Childbearing women who are pregnant or likely to be pregnant during the study period&#xD;
             and men who are neither infertile nor willing to refrain from sexual relations but&#xD;
             whose partner does not conduct an effective contraception&#xD;
&#xD;
          -  Fever due to documented fungal infection&#xD;
&#xD;
          -  Hepatic dysfunction&#xD;
&#xD;
          -  Kidney abnormalities&#xD;
&#xD;
          -  Patients who are not eligible for the study participation based on warnings,&#xD;
             precautions and contra medications in the package insert of the study drug at the&#xD;
             investigator's discretion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Korea, Ltd., Korea Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Korea, Ltd., Korea</affiliation>
  </overall_official>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>February 18, 2013</last_update_submitted>
  <last_update_submitted_qc>February 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 20, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neutropenia</keyword>
  <keyword>Hematologic malignancy</keyword>
  <keyword>Itraconazole</keyword>
  <keyword>Fungal infection</keyword>
  <keyword>Antifungal agent</keyword>
  <keyword>Neutropenic fever</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neutropenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Itraconazole</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/NCT01706562
org study id: CR017839
secondary id: ITRFUN4055
secondary id: ITR-KOR-5088
nct id: NCT01706562
lead sponsor: 
The purpose of this study is to investigate the overall success rate of itraconazole
      intravenous treatment for a period of more than 7 days.
This is a retrospective study ie, a study that looks backward in time, usually using medical
      records and interviews with patients who are already known to have a disease, in patients
      with itraconazole intravenous prescription as an empirical (based on practical experience)
      antifungal agent. This study collects baseline information about underlying disease, sign of
      fungal infection, neutropenia (a decrease in white blood cells), neutropenic fever duration
      and the reason for discontinuation. Neutropenia is defined as a neutrophil (white blood cell)
      count of ≤500 cells/mm3 or a count of ≤1000 cells/mm3 with a predicted decrease to ≤500
      cells/mm3. Fever is defined as a body temperature ≥38.3 Celsius degrees at least once a day
      with no definite external factor or a body temperature of ≥38 Celsius degrees continued for
      at least 1 hour.
observational model: Cohort
time perspective: Retrospective
measure: Success rate of itraconazole treatment when used for more than 7 days
time frame: From 7 days to approximately 2 weeks
description: Treatment success is achieved when neutropenia is resolved, ie, when the blood cells count is within the normal reference range.
measure: Success rate of itraconazole treatment until neutropenia is resolved
time frame: Approximately 2 weeks
description: Treatment success is achieved when neutropenia is resolved, ie, when the blood cells count is within the normal reference range.
measure: Drop out rate due to the lack of efficacy of itraconazole treatment
time frame: Approximately 2 weeks
arm group label: Itraconazole
intervention type: Drug
intervention name: Itraconazole
description: Itraconazole intravenous (IV) 200 mg twice daily for 2 days, a total of 4 doses and then 200 mg once daily until clinically significant resolution of neutropenia.
arm group label: Itraconazole
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Korea, Ltd., Korea Clinical Trial
role: Study Director
affiliation: Janssen Korea, Ltd., Korea
responsible party type: Sponsor
mesh term: Neutropenia
mesh term: Itraconazole