<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/NCT03799172</url>
  </required_header>
  <id_info>
    <org_study_id>CRC_GHN_2019_001</org_study_id>
    <nct_id>NCT03799172</nct_id>
  </id_info>
  <brief_title>Echinocandins Versus Azoles for Candidemia Treatment</brief_title>
  <acronym>AntiCandiTreat</acronym>
  <official_title>Echinocandins Versus Azoles as First-line Therapy for the Treatment of Candidemia in Intensive Care Units</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>
      Candidemia is the most frequent invasive fungal disease in intensive care units (ICUs). It&#xD;
      remains a major health concern, considering its attributable mortality up to 40% in&#xD;
      critically ill patients. Successful clinical outcome requires early diagnosis and effective&#xD;
      antifungal therapy. Guidelines for the treatment of candidemia were published by the&#xD;
      Infectious Diseases Society of America (IDSA) and the European Society of Clinical&#xD;
      Microbiology and Infectious Diseases (ESCMID). According to these guidelines, echinocandins&#xD;
      are the preferred first-line therapy for candidemia in critically ill patients. Considering&#xD;
      the bibliography supporting this statement, the place of triazoles still needs to be defined&#xD;
      in candidemia therapeutic arsenal. In this context, we are setting up a retrospective cohort&#xD;
      study using Hospital database to compare the efficacy of echinocandins and azoles for the&#xD;
      treatment of candidemia in intensive care units.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">February 1, 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>Comparison of all cause hospital mortality on day 90 between echinocandins and azoles</measure>
    <time_frame>Mortality on day 90 after antifungal initiation</time_frame>
    <description>Comparison of all cause hospital mortality on day 90 between echinocandins and azoles</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of treatment success on day 30 between echinocandins and azoles.</measure>
    <time_frame>Treatment success on day 30 after antifungal initiation</time_frame>
    <description>Treatment success is defined as a complete response if the following two criteria were full-filled: survival and resolution of all attributable symptoms and signs of disease, and mycological success (documented clearance of pathogen from the blood).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">79</enrollment>
  <condition>Candidemia</condition>
  <arm_group>
    <arm_group_label>Echinocandin group</arm_group_label>
    <description>Echinocandin group is the group of patients who received echinocandins as first-line therapy for candidemia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triazole group</arm_group_label>
    <description>Triazole group is the group of patients who received triazoles as first-line therapy for candidemia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Echinocandin treatment</intervention_name>
    <description>Patients received echinocandins as a first-line therapy after candidemia diagnosis according to the standard of care</description>
    <arm_group_label>Echinocandin group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triazole treatment</intervention_name>
    <description>Patients received triazoles as a first-line therapy after candidemia diagnosis according to the standard of care.&#xD;
Candidemia was defined as at least one blood culture positive for Candida.</description>
    <arm_group_label>Triazole group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a diagnosis of candidemia during their ICU stay&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who had a diagnosis of candidemia during ICU stay and were treated with&#xD;
             echinocandins or azoles&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with neutropenia&#xD;
&#xD;
          -  Patients without antifungal treatment&#xD;
&#xD;
          -  Patients who received antifungal therapy for more than two days before candidemia&#xD;
             diagnosis&#xD;
&#xD;
          -  Patients receiving liposomal amphotericin b or multiple antifungal agents as&#xD;
             first-line therapy&#xD;
&#xD;
          -  Patients who received less than 4 days of antifungal therapy after candidemia&#xD;
             diagnosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospices Civils de Lyon, Hôpital de la Croix-Rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>March 3, 2020</last_update_submitted>
  <last_update_submitted_qc>March 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Candidemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Echinocandins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03799172
org study id: CRC_GHN_2019_001
nct id: NCT03799172
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Candidemia is the most frequent invasive fungal disease in intensive care units (ICUs). It
      remains a major health concern, considering its attributable mortality up to 40% in
      critically ill patients. Successful clinical outcome requires early diagnosis and effective
      antifungal therapy. Guidelines for the treatment of candidemia were published by the
      Infectious Diseases Society of America (IDSA) and the European Society of Clinical
      Microbiology and Infectious Diseases (ESCMID). According to these guidelines, echinocandins
      are the preferred first-line therapy for candidemia in critically ill patients. Considering
      the bibliography supporting this statement, the place of triazoles still needs to be defined
      in candidemia therapeutic arsenal. In this context, we are setting up a retrospective cohort
      study using Hospital database to compare the efficacy of echinocandins and azoles for the
      treatment of candidemia in intensive care units.
observational model: Cohort
time perspective: Retrospective
measure: Comparison of all cause hospital mortality on day 90 between echinocandins and azoles
time frame: Mortality on day 90 after antifungal initiation
description: Comparison of all cause hospital mortality on day 90 between echinocandins and azoles
measure: Comparison of treatment success on day 30 between echinocandins and azoles.
time frame: Treatment success on day 30 after antifungal initiation
description: Treatment success is defined as a complete response if the following two criteria were full-filled: survival and resolution of all attributable symptoms and signs of disease, and mycological success (documented clearance of pathogen from the blood).
arm group label: Echinocandin group
description: Echinocandin group is the group of patients who received echinocandins as first-line therapy for candidemia
arm group label: Triazole group
description: Triazole group is the group of patients who received triazoles as first-line therapy for candidemia
intervention type: Drug
intervention name: Echinocandin treatment
description: Patients received echinocandins as a first-line therapy after candidemia diagnosis according to the standard of care
arm group label: Echinocandin group
intervention type: Drug
intervention name: Triazole treatment
description: Patients received triazoles as a first-line therapy after candidemia diagnosis according to the standard of care.
Candidemia was defined as at least one blood culture positive for Candida.
arm group label: Triazole group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Candidemia
mesh term: Echinocandins
sharing ipd: Undecided