Fungiscope - A Global Emerging Fungal Infection Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Cologne
Sponsor:
Collaborators:
Astellas Pharma GmbH
Gilead Sciences
Merck Sharp & Dohme Corp.
Pfizer
Information provided by (Responsible Party):
Oliver Cornely, MD, University of Cologne
ClinicalTrials.gov Identifier:
NCT01731353
First received: November 15, 2012
Last updated: December 19, 2013
Last verified: December 2013
  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 Infection

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 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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731353

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

Locations
Germany
University Hospital Cologne Recruiting
Cologne, NRW, Germany, 50924
Contact: Oliver A Cornely, Prof.    +49 221 478 ext 6494    oliver.cornely@ctuc.de   
Sub-Investigator: Maria J Vehreschild, MD         
Sub-Investigator: Kerstin Wahlers, MD         
Sub-Investigator: Janne Vehreschild, MD         
Sponsors and Collaborators
University of Cologne
Astellas Pharma GmbH
Gilead Sciences
Merck Sharp & Dohme Corp.
Pfizer
Investigators
Principal Investigator: Oliver A. Cornely, Professor University Hospital of Cologne
  More Information

Additional Information:
No publications provided

Responsible Party: Oliver Cornely, MD, Dr. med., University of Cologne
ClinicalTrials.gov Identifier: NCT01731353     History of Changes
Other Study ID Numbers: Fungi001
Study First Received: November 15, 2012
Last Updated: December 19, 2013
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by University of Cologne:
invasive fungal infection
Web-based registry

Additional relevant MeSH terms:
Mycoses

ClinicalTrials.gov processed this record on August 28, 2014