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

• Sponsor: Fadoi Foundation, Italy (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05254522
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 38.4
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fever of Unknown Origin	Other: not aplicable since it is a Registry

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

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Fever of Unknown Orgin Registry in Internal Medicine Unit and Infectious Disease Units
• Actual Study Start Date: Sep 19, 2019
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Outcome Measures

Primary Outcome Measures

1. To describe FUO cases collected [6 moths]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ASUI di Trieste	Trieste		Italy

Sponsors and Collaborators

• Fadoi Foundation, Italy

Investigators

• Study Director: ANDREA FONTANELLA, FADOI FOUNDATION

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fadoi Foundation, Italy
• ClinicalTrials.gov Identifier: NCT05254522
• Other Study ID Numbers: FADOI.07.2018
• First Posted: Feb 24, 2022
• Last Update Posted: Feb 24, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Communicable Diseases; Infections; Fever; Fever of Unknown Origin

Study Results

No Results Posted as of Feb 24, 2022