NCT05756582

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,040 (estimated)
• Sponsor: Eleonora Nucera · Academic / Other
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tuberculosis
• Tuberculosis, Pulmonary
• Tuberculosis Infection
• Latent Tuberculosis
• Health Care Associated Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-17
• Primary completion: 2026-06-30
• Completion: 2026-12-15
• First posted: 2023-03-06
• Last updated: 2024-02-13

Locations

1 site across 1 country: Italy