Fungal Vascular Graft Infections, French Multicenter Retrospective Study (FUNGIVAS)

December 9, 2025 updated by: University Hospital, Bordeaux
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with fungal infection on a vascular sample

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of mortality
Time Frame: Year 1
Rate of all-cause mortality
Year 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of mortality
Time Frame: Month 1
Rate of all-cause mortality
Month 1
Fungal vascular graft and endograft infections-related mortality
Time Frame: Month 1, Year 1
Fungal vascular graft and endograft infections-related mortality
Month 1, Year 1
Rate of cure
Time Frame: Year 1
Rate of cure, defined as : alive and without therapeutic failure (non-control of infection requiring repeat surgery or modification of anti-infective treatment)
Year 1
Rate of sequelae
Time Frame: Year 1
Rate of sequelae
Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

August 19, 2025

First Submitted That Met QC Criteria

August 19, 2025

First Posted (Estimated)

August 27, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2025/025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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