Fever of Unknown Orgin Registry in Internal Medicine Unit... | NCT05254522

Studies
Fever of Unknown Orgin Registry in Internal Medicine Unit and Infectious Disease Units

NCT05254522

Sponsor

Fadoi Foundation, Italy

Status

Unknown status

Last Update Posted

Feb 24, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Fever of Unknown Origin

Interventions

not aplicable since it is a Registry

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 19, 2019Actual

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Feb 9, 2022

First Submission Date that Met QC Criteria

Feb 15, 2022

First Posted Date

Feb 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2022

Last Update Posted Date

Feb 24, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

In particular this registry intends to record clinical data observed, diagnostic methods used and the clinical evolution of classical FUO cases

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
not aplicable since it is a Registry	Other	not aplicable since it is a registry

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To describe FUO cases collected	To describe clinical evolution of classical FUO cases recording clinical data observed, diagnostic methods used.	6 moths

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ELISA ZAGARRI'	Contact	+39 0248005140		elisa.zagarri@fadoi.org

Overall Officials

Name	Affiliation	Role
ANDREA FONTANELLA	FADOI FOUNDATION	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ASUI di Trieste	Recruiting	Trieste			Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40828443	Derived	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.

ID	Term
D005334	Fever
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms