NCT02786693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

2.8 years

First QC Date

January 8, 2016

Last Update Submit

October 9, 2018

Conditions

Fever of Unknown Origin

Keywords

TEP-scan

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • prevalence of FUO/SII :

    1 year

  • causes of FUO/SII: Proportion of each causes of FUO/SII, according to the main outcome after final diagnosis

    1 year

  • Mortality rate of patient with FUO and SII, according to the presence or absence of a final diagnosis

    1 year

  • Medical economic evaluation of the utility of the TEP scan in the diagnostic approach

    1 year

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient with fever and biologic inflammatory syndrome of unknown origin for more than a week

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Grenoble

Grenoble, 38000, France

Location

University Hospital

Grenoble, 38000, France

Location

Related Publications (5)

  • 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.

    PMID: 13734791BACKGROUND

  • Durack DT, Street AC. Fever of unknown origin--reexamined and redefined. Curr Clin Top Infect Dis. 1991;11:35-51. No abstract available.

    PMID: 1651090BACKGROUND

  • 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.

    PMID: 12603493BACKGROUND

  • 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.

    PMID: 17220753BACKGROUND

  • 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.

    PMID: 17629532BACKGROUND

Related Links

MeSH Terms

Conditions

Fever of Unknown Origin

Condition Hierarchy (Ancestors)

FeverBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Laurence Bouillet, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2016

First Posted

June 1, 2016

Study Start

December 1, 2015

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

October 10, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)