FungiScope - A Global Emerging Fungal Infection Registry | NCT01731353

Studies
FungiScope - A Global Emerging Fungal Infection Registry

NCT01731353

Sponsor

University of Cologne

Status

Recruiting

Last Update Posted

Dec 5, 2023Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Invasive Fungal Disease

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Nov 15, 2012

First Submission Date that Met QC Criteria

Nov 15, 2012

First Posted Date

Nov 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2023

Last Update Posted Date

Dec 5, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Oliver Cornely, MD, Dr. med., University of ColognePrincipal Investigator

Lead Sponsor

University of CologneOTHER

Collaborators

Name	Class
Pfizer	INDUSTRY
Basilea Pharmaceutica	INDUSTRY
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

To determine the fungal species causing invasive fungal infection in different parts of the world.
To determine the clinical pattern of disease and document procedures performed for confirmation of the diagnosis.
To describe the therapeutic regimens used and their efficacy.
To share clinical isolates among the contributors of Fungiscope.
To develop molecular biology tools for identification of strains in histopathologically proven invasive fungal infection.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Emerging fungal infections		Web-based registry of invasive infections by emerging fungi

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment efficacy of emerging fungal infections	failure, stable disease, partial response or complete response	At 90 days from diagnosis

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Invasive infections caused by emerging fungi

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Oliver A Cornely, Prof.	Contact	+49 221 478	6494	oliver.cornely@uk-koeln.de

Overall Officials

Name	Affiliation	Role
Oliver A. Cornely, Professor	University Hospital of Cologne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Cologne	Recruiting	Cologne	North Rhine-Westphalia	50937	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35144992	Derived	Koehler P, von Stillfried S, Garcia Borrega J, Fuchs F, Salmanton-Garcia J, Pult F, Boll B, Eichenauer DA, Shimabukuro-Vornhagen A, Kurzai O, Boor P, Kochanek M, Cornely OA. Aspergillus tracheobronchitis in COVID-19 patients with acute respiratory distress syndrome: a cohort study. Eur Respir J. 2022 May 5;59(5):2103142. doi: 10.1183/13993003.03142-2021. Print 2022 May.
27846057

ID	Term
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections