Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students
- Conditions
- Tuberculosis InfectionTuberculosisTuberculosis, PulmonaryLatent TuberculosisHealth Care Associated Infection
- Interventions
- Diagnostic Test: Prevalence of Latent Tuberculosis Infection
- Registration Number
- NCT05756582
- Lead Sponsor
- Eleonora Nucera
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2040
- 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.
- denied informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Health-care workers and students Prevalence of Latent Tuberculosis Infection 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.
- Primary Outcome Measures
Name Time Method The prevalence of Latent Tuberculosis Infection At enrollment. 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.
- Secondary Outcome Measures
Name Time Method Age At enrollment. Age as possible risk factor of Latent Tuberculosis Infection.
Occupation At enrollment. 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.
Working / training Unit At enrollment. Working / training Unit as possible risk factor of Latent Tuberculosis Infection.
Vaccination history At enrollment. Bacillus Calmette-Guérin (BCG) vaccination history as possible risk factor of Latent Tuberculosis Infection.
Recent exposure At enrollment. Known recent (within 6 months) exposure to TB-infected patient; as possible risk factor of Latent Tuberculosis Infection.
Smoking At enrollment. Current smoking as possible risk factor of Latent Tuberculosis Infection.
Co-morbidities / medical history At enrollment. 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.
Sex At enrollment. Sex as possible risk factor of Latent Tuberculosis Infection.
Previous work or stay in other at risk countries At enrollment. 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.
QuantiFERON-TB At enrollment. Median QuantiFERON-TB Gold In-Tube level (TB Ag-Nil) as possible risk factor of Latent Tuberculosis Infection.
Years working as HCW At enrollment. Years working as HCW as possible risk factor of Latent Tuberculosis Infection.
Trial Locations
- Locations (1)
UOSD Allergologia e Immunologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS
🇮🇹Roma, Italy