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临床试验/NCT02786693
NCT02786693已完成不适用

Evaluation of Diagnosis of Fever and Biologic Inflammatory Syndrome of Unknown Origin

University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
试验地点
2
主要终点
Presence of a final diagnosis after paraclinical explorations

研究概览

简要总结

Fever of unknown origin (FUO) and biologic inflammatory syndrome of unknown origin (SII) are two frequent causes of hospitalization or consultation in infectious disease unit and internal medicine.

There are many etiologies, in four categories: infections, auto-immune disease, cancer and miscellaneous causes. Currently there is no specifics recommendations to follow a "diagnosis way" of FUO and SII.

Purpose: Evaluation of clinical practices in the diagnosis of fever and biologic inflammatory syndrome of unknown origin, in two units of the University Grenoble Hospital.

详细描述

Fever of unknown origin (FUO) and biologic inflammatory syndrome of unknown origin (SII) are two frequent causes of hospitalization or consultation in infectious disease unit and internal medicine unit.

The initial definition for FUO was proposed by Petersdorf and Beeson in 1961 : "fever > 38,3°C, permanent or recurrent, for more than 3 weeks, without diagnosis after one week hospitalisation and explorations". This definition has been updated by Durack and Street in 1991 who distinguish "classics FUO" from 3 other categories : nosocomial, patient with HIV and neutropenia. They also choose an other way of diagnosis : 3 days of investigations in hospital OR in consultation.

Finally, Knokaert and al. proposed a new definition, based on a qualitative criterion: No diagnosis after a first step and complete clinical and paraclinical check up.

The evolution of FUO's prevalence is not describe so much. There are many etiologies, classified in four categories: infections, auto-immune disease, cancer and miscellaneous causes. The distribution of FUO's causes may change according to geographical localisation, and seems to evolve over time, with apparition of new infectious and inflammatory diseases, and the advent of new diagnosis tools.

Currently there is no specifics recommendations to follow a "diagnosis way" of FUO and SII. It starts with a complete physical examination and some first lign further exams. Without diagnosis, paraclinical explorations are continued with more specific exams, according to the presence or the absence of diagnosis clues.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • patients > 18 years old
  • with fever> 38.5°C and/or CRP> 5mg/L for more than a week
  • with standard check-up that did not allow a causal diagnosis

排除标准

  • immunosuppression : HIV, neutropenia, known cancer with chemotherapy, immunosuppressive treatment or corticotherapy (> 10mg/L for >3 weeks)
  • nosocomial fever
  • pregnant women
  • patients who are not able to sign a consent

结局指标

主要结局

Presence of a final diagnosis after paraclinical explorations

时间窗: 1 year

Final diagnosis according to the previous classification : infectious disease, inflammatory or auto-immune disease, cancer, or miscellaneous cause.

次要结局

  • causes of FUO/SII: Proportion of each causes of FUO/SII, according to the main outcome after final diagnosis(1 year)
  • prevalence of FUO/SII :(1 year)
  • Mortality rate of patient with FUO and SII, according to the presence or absence of a final diagnosis(1 year)
  • Medical economic evaluation of the utility of the TEP scan in the diagnostic approach(1 year)

研究者

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

研究点 (2)

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