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NCT Number: NCT07143409

Fungal Vascular Graft Infections, French Multicenter Retrospective 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

epidemiology and medical treatment strategies

Other

Analysis of the epidemiology and medical and surgical treatment strategies for fungal IPEV in France between January 2013 and January 2023

Primary outcomes

  1. Rate of mortality

    Time frame: Year 1

    Rate of all-cause mortality

Secondary outcomes

  1. Rate of mortality

    Time frame: Month 1

    Rate of all-cause mortality

  2. Fungal vascular graft and endograft infections-related mortality

    Time frame: Month 1, Year 1

    Fungal vascular graft and endograft infections-related mortality

  3. 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)

  4. Rate of sequelae

    Time frame: Year 1

    Rate of sequelae

Study contacts

Contact information is provided by the study sponsor or research team.

Carole Vignals, MD

CONTACT

[email protected]

+335 56 79 55 36

Mathilde Puges, MD

CONTACT

[email protected]

+335 56 79 55 36

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: FUNGIVAS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 27, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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