Clinical trial NCT02786693: Evaluation of Diagnosis of Fever and Biologic Inflammatory Syndrome of Unknown Origin
Official title: Evaluation of Diagnosis of Fever and Biologic Inflammatory Syndrome of Unknown Origin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fever of Unknown Origin
Keywords: TEP-scan
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with fever and biologic inflammatory syndrome of unknown origin for more than a week

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of a final diagnosis after paraclinical explorations
timeFrame: 1 year
Secondary outcomes:
measure: prevalence of FUO/SII :
timeFrame: 1 year
measure: causes of FUO/SII: Proportion of each causes of FUO/SII, according to the main outcome after final diagnosis
timeFrame: 1 year
measure: Mortality rate of patient with FUO and SII, according to the presence or absence of a final diagnosis
timeFrame: 1 year
measure: Medical economic evaluation of the utility of the TEP scan in the diagnostic approach
timeFrame: 1 year
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble
city: Grenoble
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Laurence Bouillet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: PETERSDORF RG, BEESON PB. Fever of unexplained origin: report on 100 cases. Medicine (Baltimore). 1961 Feb;40:1-30. doi: 10.1097/00005792-196102000-00001. No abstract available.
citation: Durack DT, Street AC. Fever of unknown origin--reexamined and redefined. Curr Clin Top Infect Dis. 1991;11:35-51. No abstract available.
citation: Knockaert DC, Vanderschueren S, Blockmans D. Fever of unknown origin in adults: 40 years on. J Intern Med. 2003 Mar;253(3):263-75. doi: 10.1046/j.1365-2796.2003.01120.x.
citation: Bleeker-Rovers CP, Vos FJ, de Kleijn EMHA, Mudde AH, Dofferhoff TSM, Richter C, Smilde TJ, Krabbe PFM, Oyen WJG, van der Meer JWM. A prospective multicenter study on fever of unknown origin: the yield of a structured diagnostic protocol. Medicine (Baltimore). 2007 Jan;86(1):26-38. doi: 10.1097/MD.0b013e31802fe858.
citation: Kucukardali Y, Oncul O, Cavuslu S, Danaci M, Calangu S, Erdem H, Topcu AW, Adibelli Z, Akova M, Karaali EA, Ozel AM, Bolaman Z, Caka B, Cetin B, Coban E, Karabay O, Karakoc C, Karan MA, Korkmaz S, Sahin GO, Pahsa A, Sirmatel F, Solmazgul E, Ozmen N, Tokatli I, Uzun C, Yakupoglu G, Besirbellioglu BA, Gul HC; Fever of Unknown Origin Study Group. The spectrum of diseases causing fever of unknown origin in Turkey: a multicenter study. Int J Infect Dis. 2008 Jan;12(1):71-9. doi: 10.1016/j.ijid.2007.04.013. Epub 2007 Jul 12.