Fungal InfectionFongiFoieNCT05150327
Multicenter Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients
An observational study of Fungal Infection, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Invasive filamentous fungal infections (aspergillosis, scedosporiosis, mucormycosis, fusarium wilt) are frequent and serious in immunocompromised individuals and especially in organ transplant patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fungal Infection
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 29 Oct 2021to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with liver transplantation with proven nvasive fungal infection with filamentous fungus between 2007-2021
Who may be able to join
- Age: from birth
- Subject with a liver transplant in one of the centers participating in the study
- Invasive fungal infection with filamentous fungus between 2007-2021
- Proven or probable infection with filamentous fungi according to EORTC/MSGERC criteria:
- Invasive aspergillosis
- Mucormycosis
Show all 10Show fewer
- Fusariosis
- Scedosporiosis
- Other infection with filamentous fungus
- Subject or legal representative for minors, who has not expressed, after information, his opposition to the reuse of his data for scientific research purposes.
Who cannot join
- Subject or (legal representative for minors) who has expressed his opposition to participating in the study
- Subject not with a liver transplant
- Subject under guardianship, curatorship or legal protection
Trial locations and contacts
1 site in 1 country.
France1 site
Service des Maladies Infectieuses et Tropicales - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: Multicenter Retrospective Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients
Invasive filamentous fungal infections (aspergillosis, scedosporiosis, mucormycosis, fusarium wilt) are frequent and serious in immunocompromised individuals and especially in organ transplant patients. There is little recent data in liver transplantation, especially on the incidence and risk factors of fungal infections
- Conditions
- Fungal Infection
- Keywords
- Fungal Infection, Immunodeficiency, Fungal filamentous, Liver transplant, Organ transplant
- Medical subject headings
- Mycoses, Immunologic Deficiency Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the incidence, risk factors and prognostic factors associated with invasive fungal filamentous fungal infections in liver transplant patients.
Measured: Files analysed retrospectively from January 01, 2007 to December 31, 2021 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start29 Oct 2021
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François DANION, MD, Study director, Service des Maladies Infectieuses et Tropicales - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150327
- Sponsor's protocol ID
- 8429
- Acronym
- FongiFoie
- Status last verified
- Sep 2024
- First submitted
- 25 Nov 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Retrospective Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT05150327
- Acronym / sponsor ID
- FongiFoie / 8429
- Conditions
- Fungal Infection
- Keywords
- Fungal Infection, Immunodeficiency, Fungal filamentous, Liver transplant, Organ transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 9 Dec 2021 (actual)
- 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.
Invasive filamentous fungal infections (aspergillosis, scedosporiosis, mucormycosis, fusarium wilt) are frequent and serious in immunocompromised individuals and especially in organ transplant patients. There is little recent data in liver transplantation, especially on the incidence and risk factors of fungal infections
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with liver transplantation with proven nvasive fungal infection with filamentous fungus between 2007-2021
Key inclusion criteria (10 listed)
- Age: from birth
- Subject with a liver transplant in one of the centers participating in the study
- Invasive fungal infection with filamentous fungus between 2007-2021
- Proven or probable infection with filamentous fungi according to EORTC/MSGERC criteria:
- Subject or legal representative for minors, who has not expressed, after information, his opposition to the reuse of his data for scientific research purposes.
Key exclusion criteria (3 listed)
- Subject or (legal representative for minors) who has expressed his opposition to participating in the study
- Subject not with a liver transplant
- Subject under guardianship, curatorship or legal protection
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
Study of the incidence, risk factors and prognostic factors associated with invasive fungal filamentous fungal infections in liver transplant patients.
Time frame: Files analysed retrospectively from January 01, 2007 to December 31, 2021 will be examined]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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. This study is not recruiting at the moment.
François DANION, MD study director
Service des Maladies Infectieuses et Tropicales - Hôpitaux Universitaires de Strasbourg
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 Fungal Infection, run by University Hospital, Strasbourg, France at 1 site in France.
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 10 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of the incidence, risk factors and prognostic factors associated with invasive fungal filamentous fungal infections in liver transplant patients. (time frame: Files analysed retrospectively from January 01, 2007 to December 31, 2021 will be examined]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.