Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prevalence of Latent Tuberculosis Infection.
- Who it may be relevant to
- Registry conditions: Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis Infection, Latent Tuberculosis. Basic parameters: 18 years — 72 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cross-sectional Study on Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students. A GENERATOR Infrastructure.
Overview
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.
Interventions
- 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 I
Primary outcome measures
- The prevalence of Latent Tuberculosis Infection [Time frame: At enrollment.]
Secondary outcome measures (11)
- Age [Time frame: At enrollment.]
- Sex [Time frame: At enrollment.]
- Vaccination history [Time frame: At enrollment.]
- Previous work or stay in other at risk countries [Time frame: At enrollment.]
- Recent exposure [Time frame: At enrollment.]
- Smoking [Time frame: At enrollment.]
- Co-morbidities / medical history [Time frame: At enrollment.]
- QuantiFERON-TB [Time frame: At enrollment.]
- Occupation [Time frame: At enrollment.]
- Working / training Unit [Time frame: At enrollment.]
- Years working as HCW [Time frame: At enrollment.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
Italy · 1 center
- UOSD Allergologia e Immunologia Clinica, Fondazione Policlinico Universitario A. Gemelli I — Roma
Publications
- Rizzi A, Nucera E, Mazzucco W, Palumbo P, Staiti D, Moscato U, De Simone FM, Sali M, Boldrini L, Capocchiano ND, Patarnello S, Rumi G, Chini R, Carusi V, Centrone M, Di Rienzo A, Longhino D, Laface C, Mellone S, Maida CM, Cannizzaro E, Cirrincione L, Verso MG, Saracino A, Di Gennaro F, Vimercati L, De Maria L, Sponselli S, Scoppettuolo G, Pastorino R, Gasbarrini A, Inchingolo R. An interoperable w PMID 40132007
Identifiers
NCT: NCT05756582 · ID3528