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FungiScope - A Global Emerging Fungal Infection Registry (FungiScope)

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.
 
ClinicalTrials.gov Identifier: NCT01731353
Recruitment Status : Recruiting
First Posted : November 21, 2012
Last Update Posted : November 4, 2022
Sponsor:
Collaborators:
Pfizer
Basilea Pharmaceutica
Cidara Therapeutics Inc.
F2G Biotech GmbH
Matinas Biopharma, Inc
Information provided by (Responsible Party):
Oliver Cornely, MD, University of Cologne

Study Description
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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
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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 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Emerging fungal infections
Web-based registry of invasive infections by emerging fungi


Outcome Measures
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Primary Outcome Measures :
  1. Treatment efficacy of emerging fungal infections [ Time Frame: At 90 days from diagnosis ]
    failure, stable disease, partial response or complete response


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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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 Candida spp., Cryptococcus neoformans, Pneumocystis jiroveci
  • Endemic fungal infection such as coccidioidomycosis or histoplasmosis
  • Colonisation or other non-invasive infection
Contacts and Locations
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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
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Contact: Oliver A Cornely, Prof. +49 221 478 ext 6494 oliver.cornely@uk-koeln.de

Locations
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Germany
University Hospital Cologne Recruiting
Cologne, NRW, Germany, 50937
Contact: Oliver A Cornely, Prof.    +49 221 478 ext 6494    oliver.cornely@uk-koeln.de   
Contact: Danila Seidel, PhD    +49 221 478 ext 97343    danila.seidel@uk-koeln.de   
Sub-Investigator: Philipp Köhler, MD         
Sponsors and Collaborators
University of Cologne
Pfizer
Basilea Pharmaceutica
Cidara Therapeutics Inc.
F2G Biotech GmbH
Matinas Biopharma, Inc
Investigators
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Principal Investigator: Oliver A. Cornely, Professor University Hospital of Cologne
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Oliver Cornely, MD, Dr. med., University of Cologne
ClinicalTrials.gov Identifier: NCT01731353    
Other Study ID Numbers: Fungi001
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: November 4, 2022
Last Verified: November 2022
Keywords provided by Oliver Cornely, MD, University of Cologne:
invasive fungal infection
Web-based registry
Additional relevant MeSH terms:
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Infections
Mycoses
Invasive Fungal Infections
Bacterial Infections and Mycoses