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Trial record 1 of 1 for:    NCT01731353
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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
Sponsor:
Collaborators:
Astellas Pharma GmbH
Gilead Sciences
Merck Sharp & Dohme Corp.
Pfizer
Basilea Pharmaceutica
Information provided by (Responsible Party):
Oliver Cornely, MD, University of Cologne

Tracking Information
First Submitted Date November 15, 2012
First Posted Date November 21, 2012
Last Update Posted Date July 19, 2016
Study Start Date March 2003
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2012)
Treatment efficacy of emerging fungal infections (failure, stable disease, partial response or complete response) [ Time Frame: At 90 days from diagnosis ]
Original Primary Outcome Measures
 (submitted: November 15, 2012)
Assess treatment efficacy of emerging fungal infections [ Time Frame: At 90 days from diagnosis ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fungiscope - A Global Emerging Fungal Infection Registry
Official Title Fungiscope - A Global Emerging Fungal Infection Registry
Brief Summary The objective of this registry is to broaden the knowledge on epidemiology, diagnostic procedures and clinical course of emerging invasive fungal infections.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
  • fixed tissue
  • fungal culture
Sampling Method Non-Probability Sample
Study Population Invasive infections caused by emerging fungi
Condition Invasive Fungal Disease
Intervention Not Provided
Study Groups/Cohorts Emerging fungal infections
Web-based registry of invasive infections by emerging fungi
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 15, 2012)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Oliver A Cornely, Prof. +49 221 478 ext 6494 oliver.cornely@uk-koeln.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01731353
Other Study ID Numbers Fungi001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Oliver Cornely, MD, University of Cologne
Study Sponsor University of Cologne
Collaborators
  • Astellas Pharma GmbH
  • Gilead Sciences
  • Merck Sharp & Dohme Corp.
  • Pfizer
  • Basilea Pharmaceutica
Investigators
Principal Investigator: Oliver A. Cornely, Professor University Hospital of Cologne
PRS Account University of Cologne
Verification Date July 2016