<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/NCT01686607</url>
  </required_header>
  <id_info>
    <org_study_id>9463-CL-1401</org_study_id>
    <nct_id>NCT01686607</nct_id>
  </id_info>
  <brief_title>Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents</brief_title>
  <acronym>MYCOS</acronym>
  <official_title>A Multicenter Cohort Study of the Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Europe B.V.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>World Health Information Science Consultants, LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This multicenter observational cohort study proposes to establish the risks of short and&#xD;
      long-term outcomes in users of parenteral micafungin and in users of other parenteral&#xD;
      antifungal agents from 2005 through 2012 with follow-up until 2017.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All eligible patients treated with a parenteral antifungal agent at any time during the years&#xD;
      2005-2012 in each of the participating hospitals, will be included in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2012</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</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>Treatment-emergent hepatic injury or dysfunction</measure>
    <time_frame>Up to 30 days after termination of the index treatment</time_frame>
    <description>Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment-emergent renal failure or dysfunction</measure>
    <time_frame>Up to 30 days after termination of the index treatment</time_frame>
    <description>Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rehospitalization for the parenteral treatment of fungal infections</measure>
    <time_frame>Up to 30 days after termination of the index treatment</time_frame>
    <description>Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Death from hepatocellular carcinoma (HCC)</measure>
    <time_frame>Up to 13 years after treatment</time_frame>
    <description>On a long-term basis up to 13 years from 2005-2017.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">40110</enrollment>
  <condition>Systemic Fungal Infections</condition>
  <arm_group>
    <arm_group_label>1) parenteral micafungin users</arm_group_label>
    <description>patients who had been treated with parenteral micafungin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2) other parenteral antifungal users</arm_group_label>
    <description>patients who had been treated with a parenteral antifungal agent (not micafungin)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Parenteral micafungin application</intervention_name>
    <description>Parenteral</description>
    <arm_group_label>1) parenteral micafungin users</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Other parenteral antifungal drugs</intervention_name>
    <description>Parenteral</description>
    <arm_group_label>2) other parenteral antifungal users</arm_group_label>
    <other_name>caspofungin</other_name>
    <other_name>anidulafungin</other_name>
    <other_name>fluconazole</other_name>
    <other_name>itraconazole</other_name>
    <other_name>voriconazole</other_name>
    <other_name>amphotericin B (various formulations)</other_name>
    <other_name>'other antifungals' include the following drugs:</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated with parenteral antifungals in tertiary referral centers across the United&#xD;
        States.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hospitalized and treated with parenteral antifungal medication&#xD;
&#xD;
          -  first time treatment of the patient with parenteral antifungal in the medical center&#xD;
             was anytime from 2005 through 2012&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prior diagnosis of hepatocellular carcinoma&#xD;
&#xD;
          -  had received parenteral antifungal therapy during the 6 months prior to index&#xD;
             hospitalization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lead Investigator</last_name>
    <role>Principal Investigator</role>
    <affiliation>WHISCON, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site US4</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US2</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US6</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US3</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US5</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site US1</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>May 31, 2019</last_update_submitted>
  <last_update_submitted_qc>May 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatic toxicity</keyword>
  <keyword>Renal toxicity</keyword>
  <keyword>Micafungin</keyword>
  <keyword>Hepatocellular carcinoma</keyword>
  <keyword>Antifungals (parenteral)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycoses</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Itraconazole</mesh_term>
    <mesh_term>Fluconazole</mesh_term>
    <mesh_term>Voriconazole</mesh_term>
    <mesh_term>Amphotericin B</mesh_term>
    <mesh_term>Caspofungin</mesh_term>
    <mesh_term>Micafungin</mesh_term>
    <mesh_term>Antifungal Agents</mesh_term>
    <mesh_term>Clotrimazole</mesh_term>
    <mesh_term>Miconazole</mesh_term>
    <mesh_term>Anidulafungin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under &quot;Sponsor Specific Details for Astellas.&quot;</ipd_description>
  </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/NCT01686607
org study id: 9463-CL-1401
nct id: NCT01686607
lead sponsor: 
collaborator: 
has dmc: No
This multicenter observational cohort study proposes to establish the risks of short and
      long-term outcomes in users of parenteral micafungin and in users of other parenteral
      antifungal agents from 2005 through 2012 with follow-up until 2017.
All eligible patients treated with a parenteral antifungal agent at any time during the years
      2005-2012 in each of the participating hospitals, will be included in the study.
observational model: Cohort
time perspective: Retrospective
measure: Treatment-emergent hepatic injury or dysfunction
time frame: Up to 30 days after termination of the index treatment
description: Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.
measure: Treatment-emergent renal failure or dysfunction
time frame: Up to 30 days after termination of the index treatment
description: Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.
measure: Rehospitalization for the parenteral treatment of fungal infections
time frame: Up to 30 days after termination of the index treatment
description: Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.
measure: Death from hepatocellular carcinoma (HCC)
time frame: Up to 13 years after treatment
description: On a long-term basis up to 13 years from 2005-2017.
arm group label: 1) parenteral micafungin users
description: patients who had been treated with parenteral micafungin
arm group label: 2) other parenteral antifungal users
description: patients who had been treated with a parenteral antifungal agent (not micafungin)
intervention type: Drug
intervention name: Parenteral micafungin application
description: Parenteral
arm group label: 1) parenteral micafungin users
intervention type: Drug
intervention name: Other parenteral antifungal drugs
description: Parenteral
arm group label: 2) other parenteral antifungal users
other name: caspofungin
other name: anidulafungin
other name: fluconazole
other name: itraconazole
other name: voriconazole
other name: amphotericin B (various formulations)
other name: 'other antifungals' include the following drugs:
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Lead Investigator
role: Principal Investigator
affiliation: WHISCON, LLC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Mycoses
mesh term: Itraconazole
mesh term: Fluconazole
mesh term: Voriconazole
mesh term: Amphotericin B
mesh term: Caspofungin
mesh term: Micafungin
mesh term: Antifungal Agents
mesh term: Clotrimazole
mesh term: Miconazole
mesh term: Anidulafungin
sharing ipd: No
ipd description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."