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临床试验/NCT04810351
NCT04810351撤回不适用

Fever of Unknown Origin (FUO) in Elderly Patients

Universitair Ziekenhuis Brussel2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
100
试验地点
2
主要终点
the spectrum of diseases responsible of FUO or IUO

研究概览

简要总结

Objective: Fever of unknown (FUO) origin remains challenging in geriatric patients. Geriatric patients have a blunted immune response responsible for altered fever mechanisms and immune cells responses. Consequently, FUO could be inappropriately named and could be changed in Inflammation of unknown origin (IUO) in this specific population. Furthermore, the studies of FUO in this group are (out)dated and the diagnostic methods have evolved achieving a better sensitivity and specificity. The aim of our study is to assess the spectrum of diseases responsible of FUO or IUO in elderly patients compared to younger patients and to define the diagnostic approach using new diagnostic investigations. The second aim of our study is to assess the usefulness of inflammatory markers, demographic data and comorbidity to differentiate the cause of FUO/IUO.

Design: Patients with FUO or IUO will prospectively be recruited at the geriatric unit and the internal medicine unit of the UZ hospital during four years. The demographic, social and medical data will be screened. All diagnostic methods will be described.

详细描述

Until today, diagnose of fever of unknown origin remains challenging in elderly patients. The presentation of the disease is often atypical and this can delay diagnose and treatment. Geriatric patients have a blunted immune response responsible for altered fever mechanisms. For example, thirty-two percent of geriatric patients presented an infection at the emergency service having no pyrexia or increased white blood cell count in the presence of an infection.

Consequently, the definition of FUO in older patients is different from younger patients. FUO in older patients is defined as tympanic or axillar fever > 37.2.0C, a rectal fever more than 37.50C or a change of > 1.3 centigrade from basal temperature during more than 3 weeks. Furthermore, the name FUO is probably not appropriate in this population and should be replaced with inflammation of unknown origin. However, Unger et al also proposed inflammation of unknown origin in a younger population.

Knockaert et al have shown that the causes of FUO are different in older patients compared to young patients. The causes of FUO are more frequently found in older patients (> 65 years old) compared to younger patients (87-95% and 79% respectively). One explanation is the atypical presentation of classic diseases in geriatric patients. Infection, multi-system diseases and neoplasms were the most prevalent causes. These studies are old and the sensitivity and specificity of the diagnostic methods used presently, such as FDG-Pet-CT, have changed. The spectrum of diseases responsible of FUO or IUO in older patients could therefore have changed since the Knockaert studies. These new diagnostic methods allow better diagnose but also faster diagnose. Consequently the definition of FUO can become obsolete in the field of the duration of the fever.

Materials and Methods

The design of the study is an observational prospective study which will start in juli 2021 until open date in function of the number of included patient (at least 50 patients in both groups).

研究设计

研究类型
Observational
观察模型
Cohort
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

  • fever during more than one week out of hospital or more than 3 weeks with an intelligent appropriate workup
  • an inflammatory syndrome during more than one week out of hospital or more than 3 weeks out of hospital

排除标准

  • no inform consent
  • Age < 18 years old
  • Neutropenia, HIV or nosocomial fever of unknown origins are excluded. Immunodepressed patients are also excluded.

研究组 & 干预措施

Younger 1

young patients ( 18-69 years old) with oral or rectal fever > 37°8 or tympanic fever > 37°2 or CRP > 30 mg/dl during more than one week but less than three weeks of hospital with appropriate intelligent standard inpatient or outpatient workup to rule out usual causes of fever

干预措施: observational study (Other)

Older 1

old patients ( > 70 years old) with oral or rectal fever > 37°8 or tympanic fever > 37°2 or CRP > 30 mg/dl during more than one week but less than three weeks out of hospital with appropriate intelligent standard inpatient or outpatient workup to rule out usual causes of fever

干预措施: observational study (Other)

Young 2

young patients (18-69 years old) with oral or rectal fever > 37°8 or tympanic fever > 37°2 or CRP > 30 mg/dl during more than 3 weeks with appropriate intelligent standard inpatient or outpatient workup to rule out usual causes of fever.

干预措施: observational study (Other)

Older 2

old patients ( > 70 years old) with oral or rectal fever fever > 37°8 or tympanic fever > 37°2 or CRP > 30 mg/dl during 3 weeks with appropriate intelligent standard inpatient or outpatient workup to rule out usual causes of fever13 .

干预措施: observational study (Other)

结局指标

主要结局

the spectrum of diseases responsible of FUO or IUO

时间窗: through study completion, an average of 1 year

The proportion of infectious diseases, of neoplasm, of multi system disease of pulmonary embolism or deep vein thrombosis, of intoxication door medication will be measured in both groups

definition of FUO

时间窗: through study completion, an average of 1 year

we would like to compare fever of unknown origin since three weeks with fever of unknown origin since one week

Diagnostic approach of FUO

时间窗: through study completion, an average of 1 year

To describe the diagnostic approach and compare these diagnostic test in young and old population.

次要结局

  • Factors which influence FUO(At baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nathalie compté

Clinic head of geriatric unit

Universitair Ziekenhuis Brussel

研究点 (2)

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