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临床试验/NCT06498310
NCT06498310招募中不适用

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

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年11月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
To identify the incidence, risk factors and prognostic factors associated with invasive fungal infections caused by filamentous fungi in heart transplant patients.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

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

时间窗: Up to 2 years

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.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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