<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/NCT01731353</url>
  </required_header>
  <id_info>
    <org_study_id>Fungi001</org_study_id>
    <nct_id>NCT01731353</nct_id>
  </id_info>
  <brief_title>FungiScope - A Global Emerging Fungal Infection Registry</brief_title>
  <acronym>FungiScope</acronym>
  <official_title>FungiScope - A Global Emerging Fungal Infection Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cologne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Basilea Pharmaceutica</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cidara Therapeutics Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>F2G Biotech GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Matinas Biopharma, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Cologne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this registry is to broaden the knowledge on epidemiology, diagnostic&#xD;
      procedures and clinical course of emerging invasive fungal infections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The specific objectives are:&#xD;
&#xD;
        1. To determine the fungal species causing invasive fungal infection in different parts of&#xD;
           the world.&#xD;
&#xD;
        2. To determine the clinical pattern of disease and document procedures performed for&#xD;
           confirmation of the diagnosis.&#xD;
&#xD;
        3. To describe the therapeutic regimens used and their efficacy.&#xD;
&#xD;
        4. To share clinical isolates among the contributors of Fungiscope.&#xD;
&#xD;
        5. To develop molecular biology tools for identification of strains in histopathologically&#xD;
           proven invasive fungal infection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>March 2003</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment efficacy of emerging fungal infections</measure>
    <time_frame>At 90 days from diagnosis</time_frame>
    <description>failure, stable disease, partial response or complete response</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Invasive Fungal Disease</condition>
  <arm_group>
    <arm_group_label>Emerging fungal infections</arm_group_label>
    <description>Web-based registry of invasive infections by emerging fungi</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  fixed tissue&#xD;
&#xD;
        -  fungal culture&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Invasive infections caused by emerging fungi&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cultural, histopathological, antigen or DNA evidence of invasive fungal infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infection due to Candida spp., Cryptococcus neoformans, Pneumocystis jiroveci&#xD;
&#xD;
          -  Endemic fungal infection such as coccidioidomycosis or histoplasmosis&#xD;
&#xD;
          -  Colonisation or other non-invasive infection&#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>Oliver A. Cornely, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Cologne</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Oliver A Cornely, Prof.</last_name>
    <phone>+49 221 478</phone>
    <phone_ext>6494</phone_ext>
    <email>oliver.cornely@uk-koeln.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital Cologne</name>
      <address>
        <city>Cologne</city>
        <state>NRW</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Oliver A Cornely, Prof.</last_name>
      <phone>+49 221 478</phone>
      <phone_ext>6494</phone_ext>
      <email>oliver.cornely@uk-koeln.de</email>
    </contact>
    <contact_backup>
      <last_name>Danila Seidel, PhD</last_name>
      <phone>+49 221 478</phone>
      <phone_ext>97343</phone_ext>
      <email>danila.seidel@uk-koeln.de</email>
    </contact_backup>
    <investigator>
      <last_name>Philipp Köhler, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.fungiscope.net</url>
    <description>FungiScope - A Global Emerging Fungal Infection Registry</description>
  </link>
  <link>
    <url>http://fungiquest.net/</url>
    <description>FungiQuest - Search Engine for rare fungal infection</description>
  </link>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 3, 2022</last_update_submitted>
  <last_update_submitted_qc>November 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cologne</investigator_affiliation>
    <investigator_full_name>Oliver Cornely, MD</investigator_full_name>
    <investigator_title>Dr. med.</investigator_title>
  </responsible_party>
  <keyword>invasive fungal infection</keyword>
  <keyword>Web-based registry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Mycoses</mesh_term>
    <mesh_term>Invasive Fungal Infections</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/NCT01731353
org study id: Fungi001
nct id: NCT01731353
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The objective of this registry is to broaden the knowledge on epidemiology, diagnostic
      procedures and clinical course of emerging invasive fungal infections.
The specific objectives are:

        1. To determine the fungal species causing invasive fungal infection in different parts of
           the world.

        2. To determine the clinical pattern of disease and document procedures performed for
           confirmation of the diagnosis.

        3. To describe the therapeutic regimens used and their efficacy.

        4. To share clinical isolates among the contributors of Fungiscope.

        5. To develop molecular biology tools for identification of strains in histopathologically
           proven invasive fungal infection.
observational model: Case-Only
time perspective: Prospective
measure: Treatment efficacy of emerging fungal infections
time frame: At 90 days from diagnosis
description: failure, stable disease, partial response or complete response
arm group label: Emerging fungal infections
description: Web-based registry of invasive infections by emerging fungi
-  fixed tissue

        -  fungal culture
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Oliver A. Cornely, Professor
role: Principal Investigator
affiliation: University Hospital of Cologne
last name: Oliver A Cornely, Prof.
phone: +49 221 478
phone ext: 6494
email: oliver.cornely@uk-koeln.de
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Germany
url: http://www.fungiscope.net
description: FungiScope - A Global Emerging Fungal Infection Registry
url: http://fungiquest.net/
description: FungiQuest - Search Engine for rare fungal infection
responsible party type: Principal Investigator
investigator affiliation: University of Cologne
investigator full name: Oliver Cornely, MD
investigator title: Dr. med.
mesh term: Infections
mesh term: Mycoses
mesh term: Invasive Fungal Infections