Invasive Fungal InfectionsIMI-CARTNCT06498310
Retrospective Study of Invasive Fungal Infections With Filamentous Fungi in Heart Transplant Patients
An observational study of Invasive Fungal Infections, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Invasive filamentous fungal infections (aspergillosis, scedosporiosis, mucormycosis, fusarium wilt) are common and serious in immunocompromised subjects and particularly organ transplant patients. There is little recent data in heart transplantation, particularly on the incidence and risk factors of fungal infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Fungal Infections
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 8 Nov 2023to 8 Nov 2025
- 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: Adult patient ≥18 years old having heart transplant and invasive fungal infection with filamentous fungi during the period from January 1, 2008 to December 31, 2022
Who may be able to join
- Adult patient ≥18 years old
- Heart transplant
- Invasive fungal infection with filamentous fungi during the period from January 1, 2008 to December 31, 2022
- Proven or probable infection with filamentous fungi according to EORTC/MSGERC criteria (20):
- Invasive aspergillosis
- Mucormycosis
Show all 10Show fewer
- Fusarium wilt
- Scedosporiosis
- Other filamentous fungus infection
- Subject who has not expressed, after information, his opposition to the reuse of his data for the purposes of this research.
Who cannot join
- Patient having expressed his opposition to participating in the study
- Patient not having a liver transplant
- Subject under guardianship, curatorship or safeguard of justice.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
Strasbourg, 67091
François DANION, MD, 33 3 69 55 15 88, francois.danion@chru-strasbourg.fr
François DANION, MD
About this study
Official title: Multicenter Retrospective Cohort Study on Invasive Fungal Infections With Filamentous Fungi in Heart Transplant Patients
Invasive filamentous fungal infections (aspergillosis, scedosporiosis, mucormycosis, fusarium wilt) are common and serious in immunocompromised subjects and particularly organ transplant patients. There is little recent data in heart transplantation, particularly on the incidence and risk factors of fungal infections. . It is therefore important to have recent data on incidence, risk and prognostic factors in order to improve the management of this severe complication.
- Conditions
- Invasive Fungal Infections
- Keywords
- Invasive Fungal Infections, Filamentous fungi, Heart transplant, Fungal infections
- Medical subject headings
- Invasive Fungal Infections, Mycoses
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the incidence, risk factors and prognostic factors associated with invasive fungal infections caused by filamentous fungi in heart transplant patients.
- Incidence: number of cases of invasive fungal infection compared to the number of heart transplant patients per year in the study centers
- Risk factors: Case-control study. Clinical, microbiological or radiological factors statistically associated with cases of invasive fungal infection compared to controls.
- Prognostic factors: Clinical, microbiological or radiological factors of invasive fungal infections associated with mortality at the 12th week.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start8 Nov 2023
- Primary completionNov 2025 (estimated)
- Study completion8 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionsStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498310
- Sponsor's protocol ID
- 9066
- Acronym
- IMI-CART
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 12 Jul 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 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Retrospective Cohort Study on Invasive Fungal Infections With Filamentous Fungi in Heart Transplant Patients
- ClinicalTrials.gov ID
- NCT06498310
- Acronym / sponsor ID
- IMI-CART / 9066
- Conditions
- Invasive Fungal Infections
- Keywords
- Invasive Fungal Infections, Filamentous fungi, Heart transplant, Fungal infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- 8 Nov 2025 (estimated)
- First posted
- 12 Jul 2024 (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 common and serious in immunocompromised subjects and particularly organ transplant patients. There is little recent data in heart transplantation, particularly on the incidence and risk factors of fungal infections. . It is therefore important to have recent data on incidence, risk and prognostic factors in order to improve the management of this severe complication.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient ≥18 years old having heart transplant and invasive fungal infection with filamentous fungi during the period from January 1, 2008 to December 31, 2022
Key inclusion criteria (10 listed)
- Adult patient ≥18 years old
- Heart transplant
- Invasive fungal infection with filamentous fungi during the period from January 1, 2008 to December 31, 2022
- Proven or probable infection with filamentous fungi according to EORTC/MSGERC criteria (20):
- Subject who has not expressed, after information, his opposition to the reuse of his data for the purposes of this research.
Key exclusion criteria (3 listed)
- Patient having expressed his opposition to participating in the study
- Patient not having a liver transplant
- Subject under guardianship, curatorship or safeguard of justice.
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
To identify the incidence, risk factors and prognostic factors associated with invasive fungal infections caused by filamentous fungi in heart transplant patients.
Time frame: Up to 2 years
1. Incidence: number of cases of invasive fungal infection compared to the number of heart transplant patients per year in the study centers 2. Risk factors: Case-control study. Clinical, microbiological or radiological factors statistically associated with cases of invasive fungal infection compared to controls. 3. Prognostic factors: Clinical, microbiological or radiological factors of invasive fungal infections associated with mortality at the 12th week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 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.
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 Infections, 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: status not confirmed, as of the sponsor's last update on 12 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François DANION, MD (33 3 69 55 15 88, francois.danion@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the incidence, risk factors and prognostic factors associated with invasive fungal infections caused by filamentous fungi in heart transplant patients. (time frame: Up to 2 years). 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 12 Jul 2024.