Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students
NCT ID: NCT05756582
Last Updated: 2024-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2040 participants
OBSERVATIONAL
2021-11-17
2026-12-15
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
72 Years
ALL
Yes
Sponsors
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Eleonora Nucera
OTHER
Responsible Party
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Eleonora Nucera
Head of Allergy Unit
Principal Investigators
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Angela Rizzi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Catholic University of Sacred Heart
Eleonora G Nucera, Prof., MD
Role: PRINCIPAL_INVESTIGATOR
Catholic University of Sacred Heart
Domenico Staiti, Prof., MD
Role: PRINCIPAL_INVESTIGATOR
Catholic University of Sacred Heart
Antonio Gasbarrini, Prof., MD
Role: STUDY_DIRECTOR
Catholic University of Sacred Heart
Vincenzo Valentini, Prof., MD
Role: STUDY_DIRECTOR
Catholic University of Sacred Heart
Locations
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UOSD Allergologia e Immunologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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 web-based platform to support health surveillance against latent tuberculosis infection in health care workers and students: The evolution of CROSSWORD study protocol. PLoS One. 2025 Mar 25;20(3):e0319568. doi: 10.1371/journal.pone.0319568. eCollection 2025.
Other Identifiers
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ID3528
Identifier Type: -
Identifier Source: org_study_id
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