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

Fever of Unknown Origin Clinical Trial

— FUO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02786693
• Other study ID #: 2015-A01627-42
• Status: Completed
• Start date: December 2015
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Fever of Unknown Origin

Locations

Country	Name	City	State
France	CHU Grenoble	Grenoble
France	University Hospital	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (5)

Bleeker-Rovers CP, Vos FJ, de Kleijn EM, Mudde AH, Dofferhoff TS, Richter C, Smilde TJ, Krabbe PF, Oyen WJ, van der Meer JW. A prospective multicenter study on fever of unknown origin: the yield of a structured diagnostic protocol. Medicine (Baltimore). 2007 Jan;86(1):26-38. — View Citation

Durack DT, Street AC. Fever of unknown origin--reexamined and redefined. Curr Clin Top Infect Dis. 1991;11:35-51. Review. — View 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. Review. — View 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. Epub 2007 Jul 12. — View Citation

PETERSDORF RG, BEESON PB. Fever of unexplained origin: report on 100 cases. Medicine (Baltimore). 1961 Feb;40:1-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of a final diagnosis after paraclinical explorations	Final diagnosis according to the previous classification : infectious disease, inflammatory or auto-immune disease, cancer, or miscellaneous cause.	1 year
Secondary	prevalence of FUO/SII :	Number of patients with FUO and SII, assessed by inclusion in the present study .	1 year
Secondary	causes of FUO/SII: Proportion of each causes of FUO/SII, according to the main outcome after final diagnosis	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.	1 year
Secondary	Mortality rate of patient with FUO and SII, according to the presence or absence of a final diagnosis	mortality rate	1 year
Secondary	Medical economic evaluation of the utility of the TEP scan in the diagnostic approach	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	1 year

External Links

•   university hospital Grenoble website