Fungal InfectionFUNGIVASNCT07143409
Fungal Vascular Graft Infections, French Multicenter Retrospective Study
An observational study of Fungal Infection and Vascular Grafting, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Fungal vascular graft and endograft infections (VGEIs) are rare but life-threatening infections. Best therapeutic management is unknown. This study retrospectively gathers fungal VGEIs from 12 university hospital centers in France over a 10 year's period in order to describe their epidemiology, clinical features… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fungal Infection, Vascular Grafting
- What is being tested?
- epidemiology and medical treatment strategies
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2026to May 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with fungal infection on a vascular sample
Who may be able to join
- Patients aged ≥ 18 years old with diagnosis of vascular graft and endograft infections (VGEI) in accordance to MAGIC criteria with diagnosis of proven invasive fungal infection according to EORTC criteria.
- No opposition to re-use data.
Who cannot join
- Patient previously treated for fungal VGEI
- Patient with suspected VGEI diagnosis based solely on prosthesis implantation in an infected site
- Poor understanding of French.
- Patient under legal protection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Bordeaux
Bordeaux
Mathilde Puges, MD, +335 56 79 55 36, mathilde.puges@u-bordeaux.fr
About this study
Fungal vascular graft and endograft infections (VGEIs) are rare but life-threatening infections. Best therapeutic management is unknown. This study retrospectively gathers fungal VGEIs from 12 university hospital centers in France over a 10 year's period in order to describe their epidemiology, clinical features, therapeutic management and outcomes. Focusing on Candida spp. VGEIs, we aim to determine prognosis factors associated with therapeutic management
Read the detailed description
Fungal vascular graft and endograft infections (VGEIs) are rare but life-threatening infections. Candida spp. is the most frequent fungal agent. Main risk factor is prostheto-digestive fistula. Best therapeutic management is unknown. The aim of FUNGIVAS study is to describe epidemiology, clinical features, therapeutic management and outcomes of fungal VGEIs and determine prognosis factors associated with therapeutic management. This study retrospectively gathers fungal VGEIs from 12 university hospital centers in France from January 2013 to January 2023. Patients will be identified from mycology laboratories that have diagnosed the fungal infection on a vascular sample. Demographic, clinical, biological, imaging and outcome data will be collected using a secure and anonymous questionnaire
- Conditions
- Fungal Infection, Vascular Grafting
- Being tested
- epidemiology and medical treatment strategies
- Keywords
- vascular graft infection, vascular endograft infection, fungi, Candida
- Medical subject headings
- Mycoses, Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidemiology and medical treatment strategiesOther
Analysis of the epidemiology and medical and surgical treatment strategies for fungal IPEV in France between January 2013 and January 2023
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of mortality
Rate of all-cause mortality
Measured: Year 1
Secondary outcomes (4)
Rate of mortality
Rate of all-cause mortality
Measured: Month 1
Fungal vascular graft and endograft infections-related mortality
Fungal vascular graft and endograft infections-related mortality
Measured: Month 1, Year 1
Rate of cure
Rate of cure, defined as : alive and without therapeutic failure (non-control of infection requiring repeat surgery or modification of anti-infective treatment)
Measured: Year 1
Rate of sequelae
Rate of sequelae
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study startJan 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
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, BordeauxThe 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 (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143409
- Sponsor's protocol ID
- CHUBX 2025/025
- Acronym
- FUNGIVAS
- Status last verified
- Dec 2025
- First submitted
- 19 Aug 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fungal Vascular Graft Infections, French Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT07143409
- Acronym / sponsor ID
- FUNGIVAS / CHUBX 2025/025
- Conditions
- Fungal Infection, Vascular Grafting
- Keywords
- vascular graft infection, vascular endograft infection, fungi, Candida
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Aug 2025 (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.
Fungal vascular graft and endograft infections (VGEIs) are rare but life-threatening infections. Best therapeutic management is unknown. This study retrospectively gathers fungal VGEIs from 12 university hospital centers in France over a 10 year's period in order to describe their epidemiology, clinical features, therapeutic management and outcomes. Focusing on Candida spp. VGEIs, we aim to determine prognosis factors associated with therapeutic management
Detailed description
Fungal vascular graft and endograft infections (VGEIs) are rare but life-threatening infections. Candida spp. is the most frequent fungal agent. Main risk factor is prostheto-digestive fistula. Best therapeutic management is unknown. The aim of FUNGIVAS study is to describe epidemiology, clinical features, therapeutic management and outcomes of fungal VGEIs and determine prognosis factors associated with therapeutic management. This study retrospectively gathers fungal VGEIs from 12 university hospital centers in France from January 2013 to January 2023. Patients will be identified from mycology laboratories that have diagnosed the fungal infection on a vascular sample. Demographic, clinical, biological, imaging and outcome data will be collected using a secure and anonymous questionnaire
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
- Patients with fungal infection on a vascular sample
Key inclusion criteria (2 listed)
- Patients aged ≥ 18 years old with diagnosis of vascular graft and endograft infections (VGEI) in accordance to MAGIC criteria with diagnosis of proven invasive fungal infection according to EORTC criteria.
- No opposition to re-use data.
Key exclusion criteria (4 listed)
- Patient previously treated for fungal VGEI
- Patient with suspected VGEI diagnosis based solely on prosthesis implantation in an infected site
- Poor understanding of French.
- Patient under 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidemiology and medical treatment strategiesAnalysis of the epidemiology and medical and surgical treatment strategies for fungal IPEV in France between January 2013 and January 2023 | Other | – |
Primary outcome
Rate of mortality
Time frame: Year 1
Rate of all-cause mortality
4 secondary outcomes
Rate of mortality
Time frame: Month 1
Fungal vascular graft and endograft infections-related mortality
Time frame: Month 1, Year 1
Rate of cure
Time frame: Year 1
Rate of sequelae
Time frame: Year 1
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 16 Dec 2025.
- Individual participant dataSharing planned: No
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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.
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 and Vascular Grafting, run by University Hospital, Bordeaux 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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 16 Dec 2025. 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?
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 Mathilde Puges, MD (+335 56 79 55 36, mathilde.puges@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of mortality (time frame: Year 1). 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 16 Dec 2025.