Fever of Unknown OriginFUONCT05254522
Fever of Unknown Orgin Registry in Internal Medicine Unit and Infectious Disease Units
An observational study of Fever of Unknown Origin, run by Fadoi Foundation, Italy at 1 site in Italy.
Trial summary
This registry has the aim to collect epidemiological and clinical data of classical FUO cases in Italian Internal medicine Dept. and in Italian Infection diseases Dept. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fever of Unknown Origin
- What is being tested?
- not aplicable since it is a Registry
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 19 Sep 2019to Dec 2022
- How long will I take part?
- 6 Months
- 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: All patients (in- or out-patients) with classical FUO hospitalised in Internal Medicine Dept. and in Infectious Diseases Dept.
Who may be able to join
- • fever (temperature > 38.3° C) found in several occasions of a duration exceeding 3, unable to make a diagnosis after a period of 3 days of hospitalization or after 3 out-patients visits in Internal Medicine Dept. or Infection Diseases Dept.
- signed informed consent
Who cannot join
- • immunocompromised patients
- patients in treatment with steroidi (prednisone > 0,5 mg/Kg/die per > 4 weeks), anti-TNF, ciclofosfamide, tacrolimus, everolimus, sirolimus, azatioprina, ciclosporina, micofenolato, metotrexate
- neutropenic patients with less than 500 neutrofili/µL
- HIV positive patients
- nocosomial fever.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ASUI di Trieste
Trieste
VERENA ZERBATO
ROBERTO LUZZATI
About this study
This registry has the aim to collect epidemiological and clinical data of classical FUO cases in Italian Internal medicine Dept. and in Italian Infection diseases Dept.
Read the detailed description
In particular this registry intends to record clinical data observed, diagnostic methods used and the clinical evolution of classical FUO cases
- Conditions
- Fever of Unknown Origin
- Being tested
- not aplicable since it is a Registry
- 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.
not aplicable since it is a RegistryOther
not aplicable since it is a registry
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe FUO cases collected
To describe clinical evolution of classical FUO cases recording clinical data observed, diagnostic methods used.
Measured: 6 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start19 Sep 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fever of Unknown OriginStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fadoi Foundation, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ANDREA FONTANELLA, Study director, FADOI FOUNDATION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254522
- Sponsor's protocol ID
- FADOI.07.2018
- Acronym
- FUO
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luzzati R, Zerbato V, Attard L, Virgili G, Cilli A, Zanier A, Libanore M, Segala D, Tedesco A, Bortolotti ME, Pontali E, Feasi M, Re A, Giarretta I, Pomero F, Zagarri E, Concia E, Dentali F, Manfellotto D, Campanini M; FADOI-FUO Study Group. Fever of unknown origin (FUO) FADOI-SIMIT Italian registry: can demographics, comorbidities, and clinical variables predict the etiology of classic FUO?-a prospective Italian study. Intern Emerg Med. 2025 Nov;20(8):2331-2340. doi: 10.1007/s11739-025-04084-1. Epub 2025 Aug 19.
PubMed 40828443
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fever of Unknown Orgin Registry in Internal Medicine Unit and Infectious Disease Units
- ClinicalTrials.gov ID
- NCT05254522
- Acronym / sponsor ID
- FUO / FADOI.07.2018
- Conditions
- Fever of Unknown Origin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fadoi Foundation, ItalyUniversity, hospital or other
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 24 Feb 2022 (actual)
- 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.
This registry has the aim to collect epidemiological and clinical data of classical FUO cases in Italian Internal medicine Dept. and in Italian Infection diseases Dept.
Detailed description
In particular this registry intends to record clinical data observed, diagnostic methods used and the clinical evolution of classical FUO cases
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients (in- or out-patients) with classical FUO hospitalised in Internal Medicine Dept. and in Infectious Diseases Dept.
Key inclusion criteria (2 listed)
- • fever (temperature > 38.3° C) found in several occasions of a duration exceeding 3, unable to make a diagnosis after a period of 3 days of hospitalization or after 3 out-patients visits in Internal Medicine Dept. or Infection Diseases Dept.
Key exclusion criteria (5 listed)
- • immunocompromised patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| not aplicable since it is a Registrynot aplicable since it is a registry | Other | – |
Primary outcome
To describe FUO cases collected
Time frame: 6 moths
To describe clinical evolution of classical FUO cases recording clinical data observed, diagnostic methods used.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Derived from this study: PubMed 40828443Luzzati R, Zerbato V, Attard L, Virgili G, Cilli A, Zanier A, Libanore M, Segala D, Tedesco A, Bortolotti ME, Pontali E, Feasi M, Re A, Giarretta I, Pomero F, Zagarri E, Concia E, Dentali F, Manfellotto D, Campanini M; FADOI-FUO Study Group. Fever of unknown origin (FUO) FADOI-SIMIT Italian registry: can demographics, comorbidities, and clinical variables predict the etiology of classic FUO?-a prospective Italian study. Intern Emerg Med. 2025 Nov;20(8):2331-2340. doi: 10.1007/s11739-025-04084-1. Epub 2025 Aug 19.
- Individual participant dataSharing planned: No
Related trials for Fever of Unknown Origin
RecruitingObservational study
Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions
Still's Disease, Adult-Onset, Systemic Inflammation
Recruiting
Comparison of FDG-PET/CT and CECT-CAP as Upfront Imaging Modality for the Diagnosis of Pyrexia of Unknown Origin
Pyrexia
Active, not recruitingPhase 3
A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)
Systemic Juvenile Idiopathic Arthritis
Active, not recruitingObservational study
PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS
Inflammatory Rheumatism, Polymyalgia Rheumatica
RecruitingObservational study
A Study on the Use of Canakinumab Among Familial Mediterranean Fever and Still's Disease Patients
Familial Mediterranean Fever, Still Disease
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.
ANDREA FONTANELLA study director
FADOI FOUNDATION
1 site 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 Fadoi Foundation, Italy at 1 site in Italy.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ELISA ZAGARRI' (+39 0248005140, elisa.zagarri@fadoi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe FUO cases collected (time frame: 6 moths). 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 NCT05254522, which also lists 1 linked publication.
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 24 Feb 2022.