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

Completed
Conditions
Fever of Unknown Origin
Registration Number
NCT02786693
Lead Sponsor
University Hospital, Grenoble
Brief Summary

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.

Detailed Description

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.

The TEP scanner has shown a great value in the diagnosis of FUO, and trend to be more performed.

Investigators propose to evaluate professional practices in the diagnosis of fever and biologic inflammatory syndrome of unknown origin, and especially the interest of TEP Scan, in two units of the University Grenoble Hospital.

Investigators will study prevalence of FUO and SII, and of each causes of FUO and SII, and the prognosis of patients with FUO and SII, according to the presence or the absence of final diagnosis, as well as the economic impact of the different complementary exams.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
39
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Presence of a final diagnosis after paraclinical explorations1 year

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

Secondary Outcome Measures
NameTimeMethod
causes of FUO/SII: Proportion of each causes of FUO/SII, according to the main outcome after final diagnosis1 year

5 possible causes : infectious diseases, auto-immune and inflammatory diseases, cancers, miscellaneous causes.

Final diagnosis is determined according to the usual criteria, reviewed by two practitioners.

prevalence of FUO/SII :1 year

Number of patients with FUO and SII, assessed by inclusion in the present study .

Mortality rate of patient with FUO and SII, according to the presence or absence of a final diagnosis1 year

mortality rate

Medical economic evaluation of the utility of the TEP scan in the diagnostic approach1 year

Benefit of TEP Scan in the diagnosis of FUO and SII : The utility is defined as an examination which allows :

* the direct diagnosis or

* direct the examination which will allow the diagnosis. The utility will be validated for every examination by 2 responsible doctors

Trial Locations

Locations (2)

University Hospital

🇫🇷

Grenoble, France

CHU Grenoble

🇫🇷

Grenoble, France

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