Clinical trial NCT01731353: FungiScope - A Global Emerging Fungal Infection Registry
Official title: FungiScope - A Global Emerging Fungal Infection Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Invasive Fungal Disease
Keywords: invasive fungal infection
Web-based registry
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Basilea Pharmaceutica
name: Cidara Therapeutics Inc.
name: F2G Biotech GmbH
name: Matinas Biopharma, Inc
First posted: 2012-11-21
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Invasive infections caused by emerging fungi

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.

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

Primary outcomes:
measure: Treatment efficacy of emerging fungal infections
timeFrame: At 90 days from diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital Cologne
state: NRW
Study officials:
affiliation: University Hospital of Cologne
name: Oliver A. Cornely, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hassler A, Lieb A, Seidel D, Cesaro S, Greil J, Klimko N, Khostelidi S, Solopova G, Ogunc D, Duran Graeff L, Cornely OA, Vehreschild MJ, Lehrnbecher T. Disseminated Fusariosis in Immunocompromised Children-Analysis of Recent Cases Identified in the Global Fungiscope Registry. Pediatr Infect Dis J. 2017 Feb;36(2):230-231. doi: 10.1097/INF.0000000000001396.
citation: Marty FM, Ostrosky-Zeichner L, Cornely OA, Mullane KM, Perfect JR, Thompson GR 3rd, Alangaden GJ, Brown JM, Fredricks DN, Heinz WJ, Herbrecht R, Klimko N, Klyasova G, Maertens JA, Melinkeri SR, Oren I, Pappas PG, Racil Z, Rahav G, Santos R, Schwartz S, Vehreschild JJ, Young JH, Chetchotisakd P, Jaruratanasirikul S, Kanj SS, Engelhardt M, Kaufhold A, Ito M, Lee M, Sasse C, Maher RM, Zeiher B, Vehreschild MJGT; VITAL and FungiScope Mucormycosis Investigators. Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis. Lancet Infect Dis. 2016 Jul;16(7):828-837. doi: 10.1016/S1473-3099(16)00071-2. Epub 2016 Mar 9.