Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students (CROSSWORD)

Cross-sectional Study on Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students. A GENERATOR Infrastructure.

This study is a cross-sectional study that examines the prevalence of Latent Tuberculosis Infection [LTBI], defined as individuals infected with Mycobacterium tuberculosis with no clinical evidence of disease, and the possible risk factors of LTBI in a large cohort of health care workers (HCWs) and students.

Study Overview

• Status: Recruiting
• Conditions: Latent Tuberculosis; Tuberculosis; Tuberculosis, Pulmonary; Health Care Associated Infection; Tuberculosis Infection
• Intervention / Treatment: Diagnostic test: Prevalence of Latent Tuberculosis Infection

Detailed Description

Mycobacterium tuberculosis may develop symptoms and signs of disease or may have no clinical evidence of disease (latent tuberculosis infection [LTBI]). TB disease remains one of the major causes of morbidity and mortality in the world.

A survey to assess the prevalence of the individuals with a LTBI and evaluate the potential main risk-factors will be performed on both HCWs and students attending the hospital wards, trained at Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome.

This study is a cross-sectional study that examines the prevalence of Latent Tuberculosis Infection [LTBI], defined as individuals infected with Mycobacterium tuberculosis (MT) with no clinical evidence of disease, and the possible risk factors of LTBI in a large cohort of health care workers (HCWs) and students.

The study will involve all HCWs of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome - a tertiary reference hospital with over 1,500 beds - and all students of all three-year and single-cycle degree courses, master's degree courses, graduate schools of the faculty of Medicine and Surgery of the Catholic University of Sacred Heart in Rome, trained at the Fondazione Policlinico Universitario A. Gemelli IRCCS.

All enrolled participants, who will agree to participate to the study and answer the questionnaire, will respond a cross-sectional questionnaire survey through dedicated tablet. The survey will contain a brief explanation of the study aims and an invitation to respond to a 9 items multiple choice questionnaire.

• Study Type: Observational
• Enrollment (Estimated): 2040

Contacts and Locations

• Study Contact: Name: Angela Rizzi, MD, PhD; Phone Number: +390630154965; Email: angela.rizzi@policlinicogemelli.it
• Study Contact Backup: Name: Raffaella Chini, MD; Phone Number: +390630154965; Email: raffaella.chini@guest.policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • UOSD Allergologia e Immunologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS
    • Sub-Investigator: Luca Boldrini, MD
    • Contact: Angela Rizzi, MD, PhD; Phone Number: +390630154965; Email: angela.rizzi@policlinicogemelli.it
    • Contact: Raffaella Chini, MD; Phone Number: +390630154965; Email: raffaella.chini@guest.policlinicogemelli.it
    • Sub-Investigator: Vincenzina Anzelmo, Prof., MD
    • Sub-Investigator: Raffaella Chini, MD
    • Sub-Investigator: Giancarlo Scoppettuolo, MD
    • Sub-Investigator: Gabriele Rumi, MD
    • Sub-Investigator: Carlotta Masciocchi, Eng.
    • Sub-Investigator: Michela Sali, MD
    • Sub-Investigator: Riccardo Inchingolo, MD, PhD
    • Sub-Investigator: Chiara La Face, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The study will involve all HCWs of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome - a tertiary reference hospital with over 1,500 beds - and all students of all three-year and single-cycle degree courses, master's degree courses, graduate schools of the faculty of Medicine and Surgery of the Catholic University of Sacred Heart in Rome, trained at the Fondazione Policlinico Universitario A. Gemelli IRCCS.

Description

Inclusion Criteria:

• all health-care workers of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome,
• all students of all three-year and single-cycle degree courses, master's degree courses, graduate schools of the faculty of Medicine and Surgery of the Catholic University of Sacred Heart in Rome, trained at the Fondazione Policlinico Universitario A. Gemelli IRCCS,
• written informed consent.

Exclusion Criteria:

• denied informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Health-care workers and students; The study will involve all health-care workers of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome - a tertiary reference hospital with over 1,500 beds - and all students of all three-year and single-cycle degree courses, master's degree courses, graduate schools of the faculty of Medicine and Surgery of the Catholic University of Sacred Heart in Rome, trained at the Fondazione Policlinico Universitario A. Gemelli IRCCS.

Diagnostic test: Prevalence of Latent Tuberculosis Infection; The prevalence of Latent Tuberculosis Infection [LTBI] is defined as 1) tuberculin conversion after a documented negative-baseline tuberculin skin test (TST), 2) positive result of the QuantiFERON-TB Gold (QFT) test performed [higher response than the cut-off value of 0.35 IU / ml of INF-γ was detected in at least one test tube (TB1 or TB2)], 3) chest imaging excluding pleural and/or pulmonary lesions suggestive of active tuberculosis and 4) final medical evaluation done by a Specialist in Infectious Diseases which excluded active disease. All four criteria must be met.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of Latent Tuberculosis Infection	The prevalence of Latent Tuberculosis Infection [LTBI] defined as 1) tuberculin conversion after a documented negative-baseline tuberculin skin test (TST), 2) positive result of the QuantiFERON-TB Gold (QFT) test performed [higher response than the cut-off value of 0.35 IU / ml of INF-γ was detected in at least one test tube (TB1 or TB2)], 3) chest imaging excluding pleural and/or pulmonary lesions suggestive of active tuberculosis and 4) final medical evaluation done by a Specialist in Infectious Diseases which excluded active disease. All four criteria must be met.	At enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age as possible risk factor of Latent Tuberculosis Infection.	At enrollment.
Sex	Sex as possible risk factor of Latent Tuberculosis Infection.	At enrollment.
Vaccination history	Bacillus Calmette-Guérin (BCG) vaccination history as possible risk factor of Latent Tuberculosis Infection.	At enrollment.
Previous work or stay in other at risk countries	Previous work or stay in other countries with high TB rates including Armenia, Azerbaijan, Belarus, Bulgaria, Estonia, Georgia, Kazakhstan, Kyrgyzstan, Latvia, Lithuania, Moldova, Romania, Russia, Tajikistan, Turkey, Turkmenistan, Ukraine and Uzbekistan; as possible risk factor of Latent Tuberculosis Infection.	At enrollment.
Recent exposure	Known recent (within 6 months) exposure to TB-infected patient; as possible risk factor of Latent Tuberculosis Infection.	At enrollment.
Smoking	Current smoking as possible risk factor of Latent Tuberculosis Infection.	At enrollment.
Co-morbidities / medical history	Co-morbidities / medical history [HIV, diabetes, silicosis, chronic kidney disease, solid organ transplant, malignant hematologic malignancies or undergoing chemotherapy, gastrectomy or fasting bypass, biological drugs]; as possible risk factor of Latent Tuberculosis Infection.	At enrollment.
QuantiFERON-TB	Median QuantiFERON-TB Gold In-Tube level (TB Ag-Nil) as possible risk factor of Latent Tuberculosis Infection.	At enrollment.
Occupation	Occupation [doctor, nurse, laboratory technicians, paramedical personnel, "preclinical" students with no contact with patients inside the hospital, and "clinical" students attending various medical, laboratory, and surgical departments of the hospital, including the infectious disease wards] as possible risk factor of Latent Tuberculosis Infection.	At enrollment.
Working / training Unit	Working / training Unit as possible risk factor of Latent Tuberculosis Infection.	At enrollment.
Years working as HCW	Years working as HCW as possible risk factor of Latent Tuberculosis Infection.	At enrollment.

Collaborators and Investigators

• Sponsor: Eleonora Nucera
• Investigators: Principal Investigator: Angela Rizzi, MD, PhD, Catholic University Of Sacred Heart; Study Director: Antonio Gasbarrini, Prof., MD, Catholic University Of Sacred Heart; Principal Investigator: Eleonora G Nucera, Prof., MD, Catholic University Of Sacred Heart; Principal Investigator: Domenico Staiti, Prof., MD, Catholic University Of Sacred Heart; Study Director: Vincenzo Valentini, Prof., MD, Catholic University Of Sacred Heart

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: February 19, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: students; survey; latent tuberculosis infection; health-care workers
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Iatrogenic Disease; Actinomycetales Infections; Mycobacterium Infections; Latent Infection; Infections; Communicable Diseases; Tuberculosis; Latent Tuberculosis; Tuberculosis, Pulmonary; Cross Infection
• Other Study ID Numbers: ID3528

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No