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临床试验/NCT07305402
NCT07305402尚未招募不适用

A French Multicenter Retrospective Study of Native and Prosthetic Vascular Infections Caused by Coxiella Burnetii (COXIVAS)

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
400
试验地点
1
主要终点
two-year mortality rate

研究概览

简要总结

high morbidity and mortality. In France, Coxiella burnetii-related vascular infections appear to be increasing, though data remain limited. Two-year mortality reaches 15-18%, mainly due to serious complications such as arterio-digestive fistulas. Diagnosis is often delayed, prognostic factors are poorly defined, and the value of advanced imaging techniques remains insufficiently studied.

详细描述

Q fever is a worldwide zoonosis that may cause chronic vascular infections with significant morbidity and mortality. In France, the incidence of Coxiella burnetii-related vascular infections appears to be increasing, although published data remain scarce. Reported two-year mortality reaches 15-18%, largely due to severe complications such as arterio-digestive fistulas. Classical risk factors include aortic aneurysm and vascular grafts, but many patients present without clear zoonotic exposure, leading to frequent underdiagnosis. Prognostic factors are poorly defined, apart from the lack of surgical management, which worsens outcomes. Diagnosis is often delayed, and the value of advanced imaging modalities such as 18F-FDG PET/CT or labeled leukocyte scintigraphy remains insufficiently studied.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Adults (≥ 18yrs old) with native or prosthetic vascular infection due to C. burnetii (Jan 2000 - Dec 2023)
  • diagnosis based on CNR vascular Q fever criteria,
  • supplemented by MAGIC (Management of Aortic Graft Infection Collaboration) criteria for prosthetic/ - endovascular infections or aortitis/arteritis criteria,
  • no objection to reuse of patient data.

排除标准

  • patient under legal protection,
  • insufficient French language comprehension

结局指标

主要结局

two-year mortality rate

时间窗: 2 years

from the time of initial management

次要结局

  • Early mortality rate(Day 30)
  • Infection-attributed mortality rate(2 years)
  • Two-year morbidity rate(2 years)
  • Rate of initial complications(2 years)
  • Rate of postoperative complications(2 years)
  • Diagnostic performance of the different imaging modalities(2 years)

研究者

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

研究点 (1)

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