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临床试验/NCT03387696
NCT03387696已完成不适用

Mucormycosis in ICU: A French Multicenter Cohort Study

University Hospital, Grenoble21 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2017年9月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
21
主要终点
Mortality at Day 28

研究概览

简要总结

Mucormycosis is an invasive fungal infection affecting patients with various clinical conditions especially patients with heavy immunosuppression or patients with trauma or extensive burns.

ZygoRéa is a retrospective and multicentric French study aimed to evaluate survival of patients with mucormycosis admitted in ICU at day-28 after admission. This study will also try also to describe the epidemiology of patients admitted in ICU.

详细描述

Mucormycosis is an invasive fungal infection affecting patients with various clinical conditions especially patients with heavy immunosuppression or patients with trauma or extensive burns. The incidence of Mucormycosis is currently increasing reaching 7% of invasive fungal infections in some immunocompromised patients. Because of its aggressive nature, Mucormycosis is associated with poor survival and high morbidity ; mortality is estimated between 16% and 64% according to different retrospective studies. No study has ever evaluated prognosis of patients with mucormycosis admitted in intensive care units (ICU).

ZygoRéa is a retrospective and multicentric French study aimed to evaluate survival of patients with mucormycosis admitted in ICU at day-28 after admission. This study will also try also to describe the epidemiology of patients admitted in ICU and to evaluate the prognosis of different subgroups of patients according to :

  • their clinical characteristics : demographic characteristics, clinical conditions and factors of immunosuppression
  • the characteristics of the fungal infection
  • the treatment strategy
  • the severity of the initial illness, evaluated by severity scores

Twenty-one French ICU are currently including more than 45 patients.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • confirmed or suspected mucormycosis, based on international definition from EORTC/MSG
  • patient hospitalized in intensive care unit during the 2008-2016 period
  • Zygomycosis identification in at least 2 solids organs or identification in hemoculture

排除标准

  • Age under 18 years old
  • Patient under the law

结局指标

主要结局

Mortality at Day 28

时间窗: up to 28 days

Mortality at Day 28 after ICU admission

次要结局

  • Length stay in ICU(up to 28 days)
  • Length stay of hospitalization(up to 90 days)
  • Mortality during the hospitalization(up to 90 days)
  • Mortality at Day 90(up to 90 days)
  • Mortality during the ICU stage(up to 28 days)
  • Prognostic criteria(up to 28 days)

研究者

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

研究点 (21)

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