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NCT Number: NCT06498310

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Strasbourg, 67091, France

Location status: Recruiting

Location contact

François DANION, MD

CONTACT

[email protected]

33 3 69 55 15 88

François DANION, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

    Time frame: Up to 2 years

    • Incidence: number of cases of invasive fungal infection compared to the number of heart transplant patients per year in the study centers
    • Risk factors: Case-control study. Clinical, microbiological or radiological factors statistically associated with cases of invasive fungal infection compared to controls.
    • Prognostic factors: Clinical, microbiological or radiological factors of invasive fungal infections associated with mortality at the 12th week.

Study contacts

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

François DANION, MD

CONTACT

[email protected]

33 3 69 55 15 88

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Multicenter Retrospective Cohort Study on Invasive Fungal Infections With Filamentous Fungi in Heart Transplant Patients

Acronym: IMI-CART

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

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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