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Fungiscope - A Global Emerging Fungal Infection Registry (Fungiscope)

This study is currently recruiting participants.
Verified July 2016 by Oliver Cornely, MD, University of Cologne
Sponsor:
ClinicalTrials.gov Identifier:
NCT01731353
First Posted: November 21, 2012
Last Update Posted: July 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Astellas Pharma GmbH
Gilead Sciences
Merck Sharp & Dohme Corp.
Pfizer
Basilea Pharmaceutica
Information provided by (Responsible Party):
Oliver Cornely, MD, University of Cologne
  Purpose
The objective of this registry is to broaden the knowledge on epidemiology, diagnostic procedures and clinical course of emerging invasive fungal infections.

Condition
Invasive Fungal Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Fungiscope - A Global Emerging Fungal Infection Registry

Resource links provided by NLM:


Further study details as provided by Oliver Cornely, MD, University of Cologne:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 1000
Study Start Date: March 2003
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Emerging fungal infections
Web-based registry of invasive infections by emerging fungi

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Criteria

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


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

Locations
Germany
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.
Pfizer
Basilea Pharmaceutica
Investigators
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 Submitted: November 15, 2012
First Posted: November 21, 2012
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:
Infection
Mycoses
Invasive Fungal Infections