<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/NCT04486885</url>
  </required_header>
  <id_info>
    <org_study_id>hj-20-ESCAI</org_study_id>
    <nct_id>NCT04486885</nct_id>
  </id_info>
  <brief_title>European Study of Cerebral Aspergillosis Treated With Isavuconazole</brief_title>
  <acronym>ESCAI</acronym>
  <official_title>European Study of Cerebral Aspergillosis Treated With Isavuconazole</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imagine Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imagine Institute</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>
      Study clinical context Cerebral aspergillosis (CA) is a rare location of invasive&#xD;
      aspergillosis (IA), associated with a high morbidity and mortality. Since 2002, voriconazole&#xD;
      is the recommended first line treatment of invasive aspergillosis. More recently,&#xD;
      isavuconazole appeared to be not less effective than voriconazole in the treatment of&#xD;
      filamentous IFI, with a better tolerance profile.&#xD;
&#xD;
      The investigators aim to evaluate better the efficacy and the safety of isavuconazole in the&#xD;
      treatment of cerebral aspergillosis by a descriptive, multicentric, international&#xD;
      retrospective cohort study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2021</start_date>
  <completion_date type="Anticipated">March 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2022</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>Outcome of the patients : alive without CA treatment/alive under CA treatment/ deceased.</measure>
    <time_frame>At baseline</time_frame>
    <description>Number of patients alive without CA treatment/alive under CA treatment/ deceased.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Monitoring of isavuconazole : dosage in the serum and in the cerebro-spinal-fluid</measure>
    <time_frame>At baseline</time_frame>
    <description>dosage of isavuconazole in the serum and in the cerebro-spinal-fluid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>-Adverse events under isavuconazole and drug interactions</measure>
    <time_frame>At baseline</time_frame>
    <description>Adverse events under isavuconazole and drug interactions</description>
  </secondary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Cerebral Aspergillosis</condition>
  <condition>Invasive Aspergillosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        40 adult ou pediatric patients, suffering frome cerebral aspergillosis, diagnosed between&#xD;
        2017 and 2020, and treated by isavuconazole at least 7 days&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Proven or probable cerebral aspergillosis according to the EORTC criteria modified by&#xD;
             adding diabetes in the host criteria&#xD;
&#xD;
          -  In child or adult&#xD;
&#xD;
          -  Treated by isavuconazole at least 7 days&#xD;
&#xD;
          -  Diagnosed between March 2017 and June 2020&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Possible cerebral aspergillosis&#xD;
&#xD;
          -  isavuconazole treatment for less than 7 days&#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>Fanny Lanternier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Necker</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fanny Lanternier, MD</last_name>
    <phone>01 44 49 52 62</phone>
    <email>fanny.lanternier@aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpital Necker-Enfants Malades</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fanny Lanternier, MD</last_name>
      <phone>01 44 49 52 62</phone>
      <email>fanny.lanternier@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>September 6, 2021</last_update_submitted>
  <last_update_submitted_qc>September 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cerebral aspergillosis</keyword>
  <keyword>isavuconazole</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspergillosis</mesh_term>
  </condition_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/NCT04486885
org study id: hj-20-ESCAI
nct id: NCT04486885
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study clinical context Cerebral aspergillosis (CA) is a rare location of invasive
      aspergillosis (IA), associated with a high morbidity and mortality. Since 2002, voriconazole
      is the recommended first line treatment of invasive aspergillosis. More recently,
      isavuconazole appeared to be not less effective than voriconazole in the treatment of
      filamentous IFI, with a better tolerance profile.

      The investigators aim to evaluate better the efficacy and the safety of isavuconazole in the
      treatment of cerebral aspergillosis by a descriptive, multicentric, international
      retrospective cohort study.
observational model: Cohort
time perspective: Retrospective
measure: Outcome of the patients : alive without CA treatment/alive under CA treatment/ deceased.
time frame: At baseline
description: Number of patients alive without CA treatment/alive under CA treatment/ deceased.
measure: Monitoring of isavuconazole : dosage in the serum and in the cerebro-spinal-fluid
time frame: At baseline
description: dosage of isavuconazole in the serum and in the cerebro-spinal-fluid
measure: -Adverse events under isavuconazole and drug interactions
time frame: At baseline
description: Adverse events under isavuconazole and drug interactions
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Fanny Lanternier, MD
role: Principal Investigator
affiliation: Hôpital Necker
last name: Fanny Lanternier, MD
phone: 01 44 49 52 62
email: fanny.lanternier@aphp.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Aspergillosis