Clinical Trial: Evaluation of Diagnosis of Fever and Biologic Inflammatory Syndrome of Unknown Origin

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Evaluation of Diagnosis of Fever and Biologic Inflammatory Syndrome of Unknown Origin

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 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 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. Sponsor: University Hospital, Grenoble

Current Primary Outcome: Presence of a final diagnosis after paraclinical explorations [ Time Frame: 1 year ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • prevalence of FUO/SII : [ Time Frame: 1 year ]
    Number of patients with FUO and SII, assessed by inclusion in the present study .
  • causes of FUO/SII: Proportion of each causes of FUO/SII, according to the main outcome after final diagnosis [ Time Frame: 1 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.

  • Mortality rate of patient with FUO and SII, according to the presence or absence of a final diagnosis [ Time Frame: 1 year ]
    mortality rate
  • Medical economic evaluation of the utility of the TEP scan in the diagnostic approach [ Time Frame: 1 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


Original Secondary Outcome: Same as current

Information By: University Hospital, Grenoble

Dates:
Date Received: January 8, 2016
Date Started: December 2015
Date Completion: December 2018
Last Updated: January 12, 2017
Last Verified: January 2017