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Not yet recruiting NCT07143409

Fungal Vascular Graft Infections, French Multicenter Retrospective Study

Observational Fungal Infection Vascular Grafting

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: epidemiology and medical treatment strategies.
Who it may be relevant to
Registry conditions: Fungal Infection, Vascular Grafting. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

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

Primary outcome measures

  • Rate of mortality [Time frame: Year 1]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • CHU Bordeaux — Bordeaux

Identifiers

NCT: NCT07143409 · CHUBX 2025/025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗