Evaluation of Diagnosis of Fever and Biologic Inflammatory Syndrome of Unknown Origin (FUO)
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|ClinicalTrials.gov Identifier: NCT02786693|
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : October 10, 2018
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.
|Condition or disease|
|Fever of Unknown Origin|
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.
|Study Type :||Observational|
|Actual Enrollment :||39 participants|
|Official Title:||Evaluation of Diagnosis of Fever and Biologic Inflammatory Syndrome of Unknown Origin|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||October 2018|
|Actual Study Completion Date :||October 2018|
FUO and SII patients
Patients with fever > 38,3°C for more than a week, OR CRP> 5mg/L, without diagnosis after a first step clinical examination and paraclinical exams.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786693
|Grenoble, France, 38000|
|Grenoble, France, 38000|
|Principal Investigator:||Laurence Bouillet, PhD||University Hospital, Grenoble|