Retrospective Study of Invasive Fungal Infections With Filamentous Fungi in Heart Transplant Patients

NCT06498310 | Recruiting

• 1 other identifier: 9066
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. . 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

Outcome Measures

Primary Outcomes (1)

• To identify the incidence, risk factors and prognostic factors associated with invasive fungal infections caused by filamentous fungi in heart transplant patients.

  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.

  Up to 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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
• 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.

You may not qualify if:

• Patient having expressed his opposition to participating in the study
• Patient not having a liver transplant
• Subject under guardianship, curatorship or safeguard of justice.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Invasive Fungal Infections; Mycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Central Study Contacts

François DANION, MD

CONTACT

33 3 69 55 15 88; francois.danion@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 12, 2024
• Study Start: November 8, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 8, 2025
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

FR (1)