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Fungiscope - A Global Emerging Fungal Infection Registry

Sponsor
University of Cologne (Other)
Overall Status
Unknown status
CT.gov ID
NCT01731353
Collaborator
Astellas Pharma GmbH (Industry), Gilead Sciences (Industry), Merck Sharp & Dohme LLC (Industry), Pfizer (Industry), Basilea Pharmaceutica (Industry)
1,000
Enrollment
1
Location
225.1
Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this registry is to broaden the knowledge on epidemiology, diagnostic procedures and clinical course of emerging invasive fungal infections.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Fungiscope - A Global Emerging Fungal Infection Registry
    Study Start Date :
    Mar 1, 2003
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Emerging fungal infections

    Web-based registry of invasive infections by emerging fungi

    Outcome Measures

    Primary Outcome Measures

    1. Treatment efficacy of emerging fungal infections (failure, stable disease, partial response or complete response) [At 90 days from diagnosis]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Cultural, histopathological, antigen, or DNA evidence of invasive fungal infection
    Exclusion Criteria:

    • Infection due to Aspergillus spp., Candida spp., Cryptococcus neoformans, Pneumocystis jiroveci

    • Endemic fungal infection such as coccidioidomycosis or histoplasmosis

    • Colonisation or other non-invasive infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Cologne Cologne NRW Germany 50937

    Sponsors and Collaborators

    • University of Cologne
    • Astellas Pharma GmbH
    • Gilead Sciences
    • Merck Sharp & Dohme LLC
    • Pfizer
    • Basilea Pharmaceutica

    Investigators

    • Principal Investigator: Oliver A. Cornely, Professor, University Hospital of Cologne

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Oliver Cornely, MD, Dr. med., University of Cologne
    ClinicalTrials.gov Identifier:
    NCT01731353
    Other Study ID Numbers:
    • Fungi001
    First Posted:
    Nov 21, 2012
    Last Update Posted:
    Jul 19, 2016
    Last Verified:
    Jul 1, 2016
    Keywords provided by Oliver Cornely, MD, Dr. med., University of Cologne
    invasive fungal infection
    Web-based registry
    Additional relevant MeSH terms:
    Infections
    Mycoses
    Invasive Fungal Infections

    Study Results

    No Results Posted as of Jul 19, 2016