<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/NCT04502771</url>
  </required_header>
  <id_info>
    <org_study_id>CRC_GHN_2020_003</org_study_id>
    <nct_id>NCT04502771</nct_id>
  </id_info>
  <brief_title>Therapeutic Drug Monitoring of Antifungals in Intensive Care Units</brief_title>
  <acronym>Fungi-up</acronym>
  <official_title>Therapeutic Drug Monitoring of Antifungals in Patients From Intensive Care Units: a Retrospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Antifungals under- and over-dosing are frequently deplored in patients treated with&#xD;
      antifungals and receiving recommended doses, mostly in critically-ill patients. This&#xD;
      situation is well-described for antifungals from the azoles class mostly in patients with&#xD;
      liver dysfunction or having concomitant drugs that may interact with azoles. This situation&#xD;
      is less-described using echinocandins, although recent studies reported caspofungin&#xD;
      underdosing for critically-ill patients. Considering that antifungals under-dosing was&#xD;
      demonstrated to be associated with an increase in mortality, it is of utmost importance to&#xD;
      analyse the relevance of therapeutic drug monitoring (TDM) for patients admitted in intensive&#xD;
      care units (ICU). This will help to identify which patients are the more prone to antifungal&#xD;
      under or over-dosing. Indeed, antifungals under-dosing may favour the development of clinical&#xD;
      resistance to antifungals and increase mortality, whereas over-dosing may result in adverse&#xD;
      events that may lead to treatment discontinuation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Antifungal blood concentration of patients admitted in intensive care units</measure>
    <time_frame>Day 5 after antifungal initiation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse event</measure>
    <time_frame>Day 30 after antifungal initiation</time_frame>
    <description>Impact of antifungal blood concentration on occurrence of adverse events and mycological failure</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Intensive Care Unit Patients</condition>
  <arm_group>
    <arm_group_label>Antifungal treatment</arm_group_label>
    <description>Patients receiving antifungal treatment during their stay in Intensive Care Unit</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antifungal treatment</intervention_name>
    <description>Treatment by fluconazole, voriconazole,posaconazole or caspofungin during the patient stay in Intensive Care Unit</description>
    <arm_group_label>Antifungal treatment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who received antifungals during their ICU stay and had a TDM&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients who received antifungals including fluconazole, voriconazole,&#xD;
             posaconazole, or caspofungin, during their ICU stay and had a Therapeutic Drug&#xD;
             Monitoring (TDM)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without antifungal treatment&#xD;
&#xD;
          -  Patients who received an antifungal combination&#xD;
&#xD;
          -  Pediatric patients&#xD;
&#xD;
          -  Patients who were not admitted in ICU&#xD;
&#xD;
          -  Patients who did not have a TDM&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospices Civils de Lyon, Croix-Rousse Hospital</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fluconazole</keyword>
  <keyword>Voriconazole</keyword>
  <keyword>Posaconazole</keyword>
  <keyword>Caspofungin</keyword>
  <keyword>Therapeutic drug monitoring</keyword>
  <keyword>Blood concentration</keyword>
  <keyword>Under-dosing</keyword>
  <keyword>Over-dosing</keyword>
  <keyword>Intensive Care Unit</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antifungal Agents</mesh_term>
    <mesh_term>Clotrimazole</mesh_term>
    <mesh_term>Miconazole</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/NCT04502771
org study id: CRC_GHN_2020_003
nct id: NCT04502771
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Antifungals under- and over-dosing are frequently deplored in patients treated with
      antifungals and receiving recommended doses, mostly in critically-ill patients. This
      situation is well-described for antifungals from the azoles class mostly in patients with
      liver dysfunction or having concomitant drugs that may interact with azoles. This situation
      is less-described using echinocandins, although recent studies reported caspofungin
      underdosing for critically-ill patients. Considering that antifungals under-dosing was
      demonstrated to be associated with an increase in mortality, it is of utmost importance to
      analyse the relevance of therapeutic drug monitoring (TDM) for patients admitted in intensive
      care units (ICU). This will help to identify which patients are the more prone to antifungal
      under or over-dosing. Indeed, antifungals under-dosing may favour the development of clinical
      resistance to antifungals and increase mortality, whereas over-dosing may result in adverse
      events that may lead to treatment discontinuation.
observational model: Cohort
time perspective: Retrospective
measure: Antifungal blood concentration of patients admitted in intensive care units
time frame: Day 5 after antifungal initiation
measure: Adverse event
time frame: Day 30 after antifungal initiation
description: Impact of antifungal blood concentration on occurrence of adverse events and mycological failure
arm group label: Antifungal treatment
description: Patients receiving antifungal treatment during their stay in Intensive Care Unit
intervention type: Drug
intervention name: Antifungal treatment
description: Treatment by fluconazole, voriconazole,posaconazole or caspofungin during the patient stay in Intensive Care Unit
arm group label: Antifungal treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Antifungal Agents
mesh term: Clotrimazole
mesh term: Miconazole