- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05254522
Fever of Unknown Orgin Registry in Internal Medicine Unit and Infectious Disease Units (FUO)
February 15, 2022 updated by: Fadoi Foundation, Italy
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
In particular this registry intends to record clinical data observed, diagnostic methods used and the clinical evolution of classical FUO cases
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ELISA ZAGARRI'
- Phone Number: +39 0248005140
- Email: elisa.zagarri@fadoi.org
Study Locations
-
-
-
Trieste, Italy
- Recruiting
- ASUI di Trieste
-
Contact:
- VERENA ZERBATO
-
Principal Investigator:
- ROBERTO LUZZATI
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients (in- or out-patients) with classical FUO hospitalised in Internal Medicine Dept.
and in Infectious Diseases Dept.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To describe FUO cases collected
Time Frame: 6 moths
|
To describe clinical evolution of classical FUO cases recording clinical data observed, diagnostic methods used.
|
6 moths
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 19, 2019
Primary Completion (ANTICIPATED)
December 1, 2022
Study Completion (ANTICIPATED)
December 1, 2022
Study Registration Dates
First Submitted
February 9, 2022
First Submitted That Met QC Criteria
February 15, 2022
First Posted (ACTUAL)
February 24, 2022
Study Record Updates
Last Update Posted (ACTUAL)
February 24, 2022
Last Update Submitted That Met QC Criteria
February 15, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FADOI.07.2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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