NCT05254522

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 19, 2019

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

3.2 years

First QC Date

February 9, 2022

Last Update Submit

February 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • To describe FUO cases collected

    To describe clinical evolution of classical FUO cases recording clinical data observed, diagnostic methods used.

    6 moths

Interventions

not aplicable since it is a registry

Eligibility Criteria

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

All patients (in- or out-patients) with classical FUO hospitalised in Internal Medicine Dept. and in Infectious Diseases Dept.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASUI di Trieste

Trieste, Italy

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Fever of Unknown Origin

Condition Hierarchy (Ancestors)

FeverBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • ANDREA FONTANELLA

    FADOI FOUNDATION

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 24, 2022

Study Start

September 19, 2019

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

February 24, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations