Invasive Fungal DiseaseFungiScopeNCT01731353
FungiScope - A Global Emerging Fungal Infection Registry
An observational study of Invasive Fungal Disease, run by University of Cologne at 1 site in Germany.
Trial summary
The objective of this registry is to broaden the knowledge on epidemiology, diagnostic procedures and clinical course of emerging invasive fungal infections. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Invasive Fungal Disease
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2003to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Invasive infections caused by emerging fungi
Who may be able to join
- Cultural, histopathological, antigen or DNA evidence of invasive fungal infection
Who cannot join
- Infection due to Candida spp., Cryptococcus neoformans, Pneumocystis jiroveci
- Endemic fungal infection such as coccidioidomycosis or histoplasmosis
- Colonisation or other non-invasive infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50937
Oliver A Cornely, Prof., +49 221 478 ext. 6494, oliver.cornely@uk-koeln.de
Danila Seidel, PhD, +49 221 478 ext. 97343, danila.seidel@uk-koeln.de
About this study
The objective of this registry is to broaden the knowledge on epidemiology, diagnostic procedures and clinical course of emerging invasive fungal infections.
Read the 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.
- Conditions
- Invasive Fungal Disease
- Keywords
- invasive fungal infection, Web-based registry
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Emerging fungal infections | Web-based registry of invasive infections by emerging fungi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficacy of emerging fungal infections
failure, stable disease, partial response or complete response
Measured: At 90 days from diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startMar 2003
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Invasive Fungal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Basilea Pharmaceutica, Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), F2G Biotech GmbH, Matinas Biopharma, Inc
- Responsible party
- Principal investigator, Oliver Cornely, MD, University of Cologne
- Investigators
- Oliver A. Cornely, Professor, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731353
- Sponsor's protocol ID
- Fungi001
- Acronym
- FungiScope
- Status last verified
- Dec 2023
- First submitted
- 15 Nov 2012
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Reinhold I, Ramirez-Sanchez IC, Chen PY, Chen YC, Dhariwal A, Lambourne J, Agrawal S, Bastida M, Gudiol C, Alfandari S, Di Pilla A, Khostelidi S, Aguilar-Zapata D, Barac A, Cipriano A, Ehrlich S, Grothe J, Illarramendi J, Jennrich S, Khedr R, Leotta D, Mendez GA, Nacov JA, Nagao M, Saydam G, Schwartz S, Steinmann J, Arn K, Enoch DA, Fohring D, Joean O, Koehler P, Krause R, Maertens J, Marchesi F, Onyeaghala C, Stone N, Vanbiervliet Y, Wolfensberger N, Haensel L, Hurrass J, Panse J, Sal E, Stemler J, Bove DS, Sprute R, Minero MV, Vena A, Pagano L, Cornely OA, Seidel D; FungiScope(R) Working Group of the European Confederation of Medical Mycology (ECMM) and the International Society for Human and Animal Mycology (ISHAM);; Fungal Infections Study Group of the European Society of Clinical Microbiology and Infectious Diseases (EFISG) and the ESCMID Study Group for Infections in Compromised Hosts (ESGICH). Treatment and outcome of chronic disseminated candidiasis in the era of antifungal prophylaxis: a retrospective multicentre cohort of 111 patients. EClinicalMedicine. 2026 Sep 16;100:104194. doi: 10.1016/j.eclinm.2026.104194. eCollection 2026 Oct.
PubMed 42774582Koehler 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.
PubMed 35144992Hassler 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.
PubMed 27846057Marty 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.
PubMed 26969258
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FungiScope - A Global Emerging Fungal Infection Registry
- ClinicalTrials.gov ID
- NCT01731353
- Acronym / sponsor ID
- FungiScope / Fungi001
- Conditions
- Invasive Fungal Disease
- Keywords
- invasive fungal infection, Web-based registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Pfizer, Basilea Pharmaceutica, Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), F2G Biotech GmbH, Matinas Biopharma, Inc
- Study start
- Mar 2003
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emerging fungal infections | – | –Web-based registry of invasive infections by emerging fungi |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Invasive infections caused by emerging fungi
Key inclusion criteria (1 listed)
- Cultural, histopathological, antigen or DNA evidence of invasive fungal infection
Key exclusion criteria (3 listed)
- Infection due to Candida spp., Cryptococcus neoformans, Pneumocystis jiroveci
- Endemic fungal infection such as coccidioidomycosis or histoplasmosis
- Colonisation or other non-invasive infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment efficacy of emerging fungal infections
Time frame: At 90 days from diagnosis
failure, stable disease, partial response or complete response
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 42774582Reinhold I, Ramirez-Sanchez IC, Chen PY, Chen YC, Dhariwal A, Lambourne J, Agrawal S, Bastida M, Gudiol C, Alfandari S, Di Pilla A, Khostelidi S, Aguilar-Zapata D, Barac A, Cipriano A, Ehrlich S, Grothe J, Illarramendi J, Jennrich S, Khedr R, Leotta D, Mendez GA, Nacov JA, Nagao M, Saydam G, Schwartz S, Steinmann J, Arn K, Enoch DA, Fohring D, Joean O, Koehler P, Krause R, Maertens J, Marchesi F, Onyeaghala C, Stone N, Vanbiervliet Y, Wolfensberger N, Haensel L, Hurrass J, Panse J, Sal E, Stemler J, Bove DS, Sprute R, Minero MV, Vena A, Pagano L, Cornely OA, Seidel D; FungiScope(R) Working Group of the European Confederation of Medical Mycology (ECMM) and the International Society for Human and Animal Mycology (ISHAM);; Fungal Infections Study Group of the European Society of Clinical Microbiology and Infectious Diseases (EFISG) and the ESCMID Study Group for Infections in Compromised Hosts (ESGICH). Treatment and outcome of chronic disseminated candidiasis in the era of antifungal prophylaxis: a retrospective multicentre cohort of 111 patients. EClinicalMedicine. 2026 Sep 16;100:104194. doi: 10.1016/j.eclinm.2026.104194. eCollection 2026 Oct.
- Derived from this study: PubMed 35144992Koehler 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.
- Derived from this study: PubMed 27846057Hassler 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.
- Derived from this study: PubMed 26969258Marty 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.
- FungiScope - A Global Emerging Fungal Infection RegistryLink provided by the sponsor.
- FungiQuest - Search Engine for rare fungal infectionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oliver A. Cornely, Professor principal investigator
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Fungal Disease, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oliver A Cornely, Prof. (+49 221 478 ext. 6494, oliver.cornely@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficacy of emerging fungal infections (time frame: At 90 days from diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01731353, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.