Fever of Unknown Origin (FUO) in Elderly Patients

NCT04810351 | Withdrawn DMC

• 1 other identifier: UZCompte2
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Fever of unknown (FUO) origin remains challenging in geriatric patients. Geriatric patients have a blunted immune response responsible for altered fever mechanisms and immune cells responses. Consequently, FUO could be inappropriately named and could be changed in Inflammation of unknown origin (IUO) in this specific population. Furthermore, the studies of FUO in this group are (out)dated and the diagnostic methods have evolved achieving a better sensitivity and specificity. The aim of our study is to assess the spectrum of diseases responsible of FUO or IUO in elderly patients compared to younger patients and to define the diagnostic approach using new diagnostic investigations. The second aim of our study is to assess the usefulness of inflammatory markers, demographic data and comorbidity to differentiate the cause of FUO/IUO. Design: Patients with FUO or IUO will prospectively be recruited at the geriatric unit and the internal medicine unit of the UZ hospital during four years. The demographic, social and medical data will be screened. All diagnostic methods will be described.

Conditions

Fever of Unknown Origin

Keywords

FUO; Fever of unknown origin

Outcome Measures

Primary Outcomes (3)

• the spectrum of diseases responsible of FUO or IUO

  The proportion of infectious diseases, of neoplasm, of multi system disease of pulmonary embolism or deep vein thrombosis, of intoxication door medication will be measured in both groups

  through study completion, an average of 1 year

• definition of FUO

  we would like to compare fever of unknown origin since three weeks with fever of unknown origin since one week

  through study completion, an average of 1 year

• Diagnostic approach of FUO

  To describe the diagnostic approach and compare these diagnostic test in young and old population.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Factors which influence FUO

  At baseline

Study Arms (4)

Younger 1

young patients ( 18-69 years old) with oral or rectal fever \> 37°8 or tympanic fever \> 37°2 or CRP \> 30 mg/dl during more than one week but less than three weeks of hospital with appropriate intelligent standard inpatient or outpatient workup to rule out usual causes of fever

Other: observational study

Older 1

old patients ( \> 70 years old) with oral or rectal fever \> 37°8 or tympanic fever \> 37°2 or CRP \> 30 mg/dl during more than one week but less than three weeks out of hospital with appropriate intelligent standard inpatient or outpatient workup to rule out usual causes of fever

Other: observational study

Young 2

young patients (18-69 years old) with oral or rectal fever \> 37°8 or tympanic fever \> 37°2 or CRP \> 30 mg/dl during more than 3 weeks with appropriate intelligent standard inpatient or outpatient workup to rule out usual causes of fever.

Other: observational study

Older 2

old patients ( \> 70 years old) with oral or rectal fever fever \> 37°8 or tympanic fever \> 37°2 or CRP \> 30 mg/dl during 3 weeks with appropriate intelligent standard inpatient or outpatient workup to rule out usual causes of fever13 .

Other: observational study

Interventions

observational study OTHER

There is no intervention. It is an observational study

Older 1; Older 2; Young 2; Younger 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited at the geriatric unit and internal medicine unit or geriatric outpatient clinic of UZ Brussel and will be followed during one year. Cfr inclusion and exclusion criteria

You may qualify if:

• fever during more than one week out of hospital or more than 3 weeks with an intelligent appropriate workup
• an inflammatory syndrome during more than one week out of hospital or more than 3 weeks out of hospital

You may not qualify if:

• no inform consent
• Age \< 18 years old
• Neutropenia, HIV or nosocomial fever of unknown origins are excluded. Immunodepressed patients are also excluded.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ brussel

Brussels, Jette, 1090, Belgium

Location

Related Publications (12)

• Norman DC. Fever in the elderly. Clin Infect Dis. 2000 Jul;31(1):148-51. doi: 10.1086/313896. Epub 2000 Jul 25.

  PMID: 10913413 BACKGROUND

• Norman DC, Yoshikawa TT. Fever in the elderly. Infect Dis Clin North Am. 1996 Mar;10(1):93-9. doi: 10.1016/s0891-5520(05)70288-9.

  PMID: 8698997 BACKGROUND

• Tal S, Guller V, Gurevich A. Fever of unknown origin in older adults. Clin Geriatr Med. 2007 Aug;23(3):649-68, viii. doi: 10.1016/j.cger.2007.03.004.

  PMID: 17631239 BACKGROUND

• Tal S, Guller V, Gurevich A, Levi S. Fever of unknown origin in the elderly. J Intern Med. 2002 Oct;252(4):295-304. doi: 10.1046/j.1365-2796.2002.01042.x.

  PMID: 12366602 BACKGROUND

• Norman DC, Wong MB, Yoshikawa TT. Fever of unknown origin in older persons. Infect Dis Clin North Am. 2007 Dec;21(4):937-45, viii. doi: 10.1016/j.idc.2007.09.003.

  PMID: 18061083 BACKGROUND

• Vanderschueren S, Del Biondo E, Ruttens D, Van Boxelaer I, Wauters E, Knockaert DD. Inflammation of unknown origin versus fever of unknown origin: two of a kind. Eur J Intern Med. 2009 Jul;20(4):415-8. doi: 10.1016/j.ejim.2009.01.002. Epub 2009 Feb 1.

  PMID: 19524186 BACKGROUND

• Knockaert DC, Vanneste LJ, Bobbaers HJ. Fever of unknown origin in elderly patients. J Am Geriatr Soc. 1993 Nov;41(11):1187-92. doi: 10.1111/j.1532-5415.1993.tb07301.x.

  PMID: 8227892 BACKGROUND

• Woolery WA, Franco FR. Fever of unknown origin: keys to determining the etiology in older patients. Geriatrics. 2004 Oct;59(10):41-5.

  PMID: 15508555 BACKGROUND

• Gafter-Gvili A, Raibman S, Grossman A, Avni T, Paul M, Leibovici L, Tadmor B, Groshar D, Bernstine H. [18F]FDG-PET/CT for the diagnosis of patients with fever of unknown origin. QJM. 2015 Apr;108(4):289-98. doi: 10.1093/qjmed/hcu193. Epub 2014 Sep 9.

  PMID: 25208896 BACKGROUND

• Schonau V, Vogel K, Englbrecht M, Wacker J, Schmidt D, Manger B, Kuwert T, Schett G. The value of 18F-FDG-PET/CT in identifying the cause of fever of unknown origin (FUO) and inflammation of unknown origin (IUO): data from a prospective study. Ann Rheum Dis. 2018 Jan;77(1):70-77. doi: 10.1136/annrheumdis-2017-211687. Epub 2017 Sep 19.

  PMID: 28928271 BACKGROUND

• Mardi D, Fwity B, Lobmann R, Ambrosch A. Mean cell volume of neutrophils and monocytes compared with C-reactive protein, interleukin-6 and white blood cell count for prediction of sepsis and nonsystemic bacterial infections. Int J Lab Hematol. 2010 Aug 1;32(4):410-8. doi: 10.1111/j.1751-553X.2009.01202.x. Epub 2009 Nov 16.

  PMID: 19919621 BACKGROUND

• Fusco FM, Pisapia R, Nardiello S, Cicala SD, Gaeta GB, Brancaccio G. Fever of unknown origin (FUO): which are the factors influencing the final diagnosis? A 2005-2015 systematic review. BMC Infect Dis. 2019 Jul 22;19(1):653. doi: 10.1186/s12879-019-4285-8.

  PMID: 31331269 BACKGROUND

MeSH Terms

Conditions

Fever of Unknown Origin

Interventions

Observation

Condition Hierarchy (Ancestors)

Fever; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Nathalie Compte, MD, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinic head of geriatric unit

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 22, 2021
• Study Start: October 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)