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Fungiscope - A Global Emerging Fungal Infection Registry (Fungiscope)

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ClinicalTrials.gov Identifier: NCT01731353
Recruitment Status : Recruiting
First Posted : November 21, 2012
Last Update Posted : July 19, 2016
Information provided by (Responsible Party):

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
Invasive Fungal Disease

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
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Fungiscope - A Global Emerging Fungal Infection Registry
Study Start Date : March 2003
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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) [ Time Frame: At 90 days from diagnosis ]

Biospecimen Retention:   Samples Without DNA
  • fixed tissue
  • fungal culture

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Invasive infections caused by emerging fungi

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731353

Contact: Oliver A Cornely, Prof. +49 221 478 ext 6494 oliver.cornely@uk-koeln.de

University Hospital Cologne Recruiting
Cologne, NRW, Germany, 50937
Contact: Oliver A Cornely, Prof.    +49 221 478 ext 6494    oliver.cornely@uk-koeln.de   
Sub-Investigator: Maria JGT Vehreschild, MD         
Sub-Investigator: Janne Vehreschild, MD         
Sponsors and Collaborators
University of Cologne
Astellas Pharma GmbH
Gilead Sciences
Merck Sharp & Dohme Corp.
Basilea Pharmaceutica
Principal Investigator: Oliver A. Cornely, Professor University Hospital of Cologne
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oliver Cornely, MD, Dr. med., University of Cologne
ClinicalTrials.gov Identifier: NCT01731353     History of Changes
Other Study ID Numbers: Fungi001
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016

Keywords provided by Oliver Cornely, MD, University of Cologne:
invasive fungal infection
Web-based registry

Additional relevant MeSH terms:
Invasive Fungal Infections