<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/NCT02214771</url>
  </required_header>
  <id_info>
    <org_study_id>FR-FID-NI-001</org_study_id>
    <nct_id>NCT02214771</nct_id>
  </id_info>
  <brief_title>Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients</brief_title>
  <acronym>DAFNE</acronym>
  <official_title>Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients (DAFNE Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma S.A.S.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to describe the characteristics and the methods of management and follow-up of&#xD;
      patients treated with fidaxomicin for Clostridium difficile infection (CDI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 3, 2014</start_date>
  <completion_date type="Actual">August 17, 2017</completion_date>
  <primary_completion_date type="Actual">March 27, 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Characteristics of patients treated with fidaxomicin, including demographic data, description of comorbidities and treatment by antibiotherapy</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Characteristics of the CDI treated with fidaxomicin, including date of CDI diagnosis, department requesting the diagnosis of CDI, methods used, severity of CDI and origin of the case</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Therapeutic management of the CDI, including the starting date of the treatment, CDI treatment first line and associated treatment</measure>
    <time_frame>Day 1</time_frame>
    <description>For patients treated with fidaxomicin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and timing of recurrences in patients treated with fidaxomicin over a 3-month follow-up period</measure>
    <time_frame>End of the follow-up (3 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events and serious adverse events occurring on fidaxomicin</measure>
    <time_frame>End of the follow-up (3 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of patients diagnosed with CDI, including demographic data and treatment by antibiotherapy</measure>
    <time_frame>Day 1</time_frame>
    <description>For all patients diagnosed with CDI regardless of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of the CDI, including date of CDI diagnosis, Department requesting the diagnosis of CDI, methods used, severity of CDI and origin of the case</measure>
    <time_frame>Day 1</time_frame>
    <description>For all patients diagnosed with CDI regardless of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment of the CDI including treatment selected and dosage</measure>
    <time_frame>Day 1</time_frame>
    <description>For all patients diagnosed with CDI regardless of treatment</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">296</enrollment>
  <condition>Clostridium Difficile Infection</condition>
  <arm_group>
    <arm_group_label>1: CDI in patients treated with fidaxomicin</arm_group_label>
    <description>Diagnosed with a CDI and treated with fidaxomicin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2: CDI in patients receiving treatment other than fidaxomicin</arm_group_label>
    <description>Diagnosed with a CDI, regardless of the prescribed treatment (not fidaxomicin)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fidaxomicin</intervention_name>
    <description>oral</description>
    <arm_group_label>1: CDI in patients treated with fidaxomicin</arm_group_label>
    <other_name>Dificid</other_name>
    <other_name>ASP2819</other_name>
    <other_name>Dificlir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment for CDI other than fidaxomicin Type</intervention_name>
    <description>Oral</description>
    <arm_group_label>2: CDI in patients receiving treatment other than fidaxomicin</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult hospitalized patients diagnosed with clostridium difficile infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized patient&#xD;
&#xD;
          -  Patient diagnosed with CDI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient already included in this study&#xD;
&#xD;
          -  Patient is taking part in a clinical trial in the field of CDI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical and Scientific Affairs manager</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma S.A.S.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Bethune</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Boulogne Billancourt</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Caen Cedex 9</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Chambéry</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Clermond-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Clichy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Garches</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>La Tronche</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Morlaix</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Mulhouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Nimes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Orléans Cedex 2</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Rennes Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Roubaix Cedex 1</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site</name>
      <address>
        <city>Soissons</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>May 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>October 11, 2017</last_update_submitted>
  <last_update_submitted_qc>October 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Clostridium difficile infection CDI</keyword>
  <keyword>Observational</keyword>
  <keyword>Fidaxomicin recurrence</keyword>
  <keyword>France</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Clostridium Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fidaxomicin</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/NCT02214771
org study id: FR-FID-NI-001
nct id: NCT02214771
lead sponsor: 
has dmc: No
The study aims to describe the characteristics and the methods of management and follow-up of
      patients treated with fidaxomicin for Clostridium difficile infection (CDI).
observational model: Cohort
time perspective: Prospective
measure: Characteristics of patients treated with fidaxomicin, including demographic data, description of comorbidities and treatment by antibiotherapy
time frame: Day 1
measure: Characteristics of the CDI treated with fidaxomicin, including date of CDI diagnosis, department requesting the diagnosis of CDI, methods used, severity of CDI and origin of the case
time frame: Day 1
measure: Therapeutic management of the CDI, including the starting date of the treatment, CDI treatment first line and associated treatment
time frame: Day 1
description: For patients treated with fidaxomicin
measure: Number and timing of recurrences in patients treated with fidaxomicin over a 3-month follow-up period
time frame: End of the follow-up (3 months)
measure: Adverse events and serious adverse events occurring on fidaxomicin
time frame: End of the follow-up (3 months)
measure: Characteristics of patients diagnosed with CDI, including demographic data and treatment by antibiotherapy
time frame: Day 1
description: For all patients diagnosed with CDI regardless of treatment
measure: Characteristics of the CDI, including date of CDI diagnosis, Department requesting the diagnosis of CDI, methods used, severity of CDI and origin of the case
time frame: Day 1
description: For all patients diagnosed with CDI regardless of treatment
measure: Treatment of the CDI including treatment selected and dosage
time frame: Day 1
description: For all patients diagnosed with CDI regardless of treatment
arm group label: 1: CDI in patients treated with fidaxomicin
description: Diagnosed with a CDI and treated with fidaxomicin
arm group label: 2: CDI in patients receiving treatment other than fidaxomicin
description: Diagnosed with a CDI, regardless of the prescribed treatment (not fidaxomicin)
intervention type: Drug
intervention name: Fidaxomicin
description: oral
arm group label: 1: CDI in patients treated with fidaxomicin
other name: Dificid
other name: ASP2819
other name: Dificlir
intervention type: Drug
intervention name: Treatment for CDI other than fidaxomicin Type
description: Oral
arm group label: 2: CDI in patients receiving treatment other than fidaxomicin
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical and Scientific Affairs manager
role: Study Director
affiliation: Astellas Pharma S.A.S.
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country: France
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Clostridium Infections
mesh term: Fidaxomicin
sharing ipd: Undecided