Clinical trial NCT05756582: Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students
Official title: Cross-sectional Study on Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students. A GENERATOR Infrastructure.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tuberculosis
Tuberculosis, Pulmonary
Tuberculosis Infection
Latent Tuberculosis
Health Care Associated Infection
Keywords: latent tuberculosis infection
health-care workers
students
survey
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 2040
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The prevalence of Latent Tuberculosis Infection
timeFrame: At enrollment.
Secondary outcomes:
measure: Age
timeFrame: At enrollment.
measure: Sex
timeFrame: At enrollment.
measure: Vaccination history
timeFrame: At enrollment.
measure: Previous work or stay in other at risk countries
timeFrame: At enrollment.
measure: Recent exposure
timeFrame: At enrollment.
measure: Smoking
timeFrame: At enrollment.
measure: Co-morbidities / medical history
timeFrame: At enrollment.
measure: QuantiFERON-TB
timeFrame: At enrollment.
measure: Occupation
timeFrame: At enrollment.
measure: Working / training Unit
timeFrame: At enrollment.
measure: Years working as HCW
timeFrame: At enrollment.
Other outcomes:
Locations:
city: Roma
country: Italy
facility: UOSD Allergologia e Immunologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Catholic University of Sacred Heart
name: Angela Rizzi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University of Sacred Heart
name: Eleonora G Nucera, Prof., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University of Sacred Heart
name: Domenico Staiti, Prof., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University of Sacred Heart
name: Antonio Gasbarrini, Prof., MD
role: STUDY_DIRECTOR
affiliation: Catholic University of Sacred Heart
name: Vincenzo Valentini, Prof., MD
role: STUDY_DIRECTOR
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