Fever of Unknown OriginFUONCT02786693
Evaluation of Diagnosis of Fever and Biologic Inflammatory Syndrome of Unknown Origin
An observational study of Fever of Unknown Origin, run by University Hospital, Grenoble at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fever of Unknown Origin
- How many people
- 39 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2015to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with fever and biologic inflammatory syndrome of unknown origin for more than a week
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fever of Unknown Origin
- Keywords
- TEP-scan
- Medical subject headings
- Fever of Unknown Origin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
prevalence of FUO/SII :
Number of patients with FUO and SII, assessed by inclusion in the present study .
Measured: 1 year
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.
Measured: 1 year
Mortality rate of patient with FUO and SII, according to the presence or absence of a final diagnosis
mortality rate
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startDec 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fever of Unknown OriginStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence Bouillet, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786693
- Sponsor's protocol ID
- 2015-A01627-42
- Acronym
- FUO
- Status last verified
- Oct 2018
- First submitted
- 8 Jan 2016
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 13734791Durack DT, Street AC. Fever of unknown origin--reexamined and redefined. Curr Clin Top Infect Dis. 1991;11:35-51. No abstract available.
PubMed 1651090Knockaert 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.
PubMed 12603493Bleeker-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.
PubMed 17220753Kucukardali 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.
PubMed 17629532
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnosis of Fever and Biologic Inflammatory Syndrome of Unknown Origin
- ClinicalTrials.gov ID
- NCT02786693
- Acronym / sponsor ID
- FUO / 2015-A01627-42
- Conditions
- Fever of Unknown Origin
- Keywords
- TEP-scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with fever and biologic inflammatory syndrome of unknown origin for more than a week
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
prevalence of FUO/SII :
Time frame: 1 year
causes of FUO/SII: Proportion of each causes of FUO/SII, according to the main outcome after final diagnosis
Time frame: 1 year
Mortality rate of patient with FUO and SII, according to the presence or absence of a final diagnosis
Time frame: 1 year
Medical economic evaluation of the utility of the TEP scan in the diagnostic approach
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Background: PubMed 13734791PETERSDORF 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.
- Background: PubMed 1651090Durack DT, Street AC. Fever of unknown origin--reexamined and redefined. Curr Clin Top Infect Dis. 1991;11:35-51. No abstract available.
- Background: PubMed 12603493Knockaert 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.
- Background: PubMed 17220753Bleeker-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.
- Background: PubMed 17629532Kucukardali 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.
- university hospital Grenoble websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Bouillet, PhD principal investigator
University Hospital, Grenoble
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever of Unknown Origin, run by University Hospital, Grenoble at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of a final diagnosis after paraclinical explorations (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02786693, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.