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

NCT05756582 | Recruiting

• 1 other identifier: ID3528
• Study Type: observational
• Target: 2,040
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

latent tuberculosis infection; health-care workers; students; survey

Outcome Measures

Primary Outcomes (1)

• The prevalence of Latent Tuberculosis Infection

  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.

  At enrollment.

Secondary Outcomes (11)

• Age

  At enrollment.

• Sex

  At enrollment.

• Vaccination history

  At enrollment.

• Previous work or stay in other at risk countries

  At enrollment.

• Recent exposure

  At enrollment.

Study Arms (1)

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.

Diagnostic Test: Prevalence of Latent Tuberculosis Infection

Interventions

Prevalence of Latent Tuberculosis Infection DIAGNOSTIC_TEST

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.

Health-care workers and students

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• denied informed consent.

Sponsors & Collaborators

• Eleonora Nucera: lead

Study Sites (1)

UOSD Allergologia e Immunologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 40132007 DERIVED

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Pulmonary; Latent Tuberculosis; Cross Infection

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Latent Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Angela Rizzi, MD, PhD

  Catholic University of Sacred Heart

  PRINCIPAL INVESTIGATOR

• Eleonora G Nucera, Prof., MD

  Catholic University of Sacred Heart

  PRINCIPAL INVESTIGATOR

• Domenico Staiti, Prof., MD

  Catholic University of Sacred Heart

  PRINCIPAL INVESTIGATOR

• Antonio Gasbarrini, Prof., MD

  Catholic University of Sacred Heart

  STUDY DIRECTOR

• Vincenzo Valentini, Prof., MD

  Catholic University of Sacred Heart

  STUDY DIRECTOR

Central Study Contacts

Angela Rizzi, MD, PhD

CONTACT

+390630154965; angela.rizzi@policlinicogemelli.it

Raffaella Chini, MD

CONTACT

+390630154965; raffaella.chini@guest.policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Allergy Unit

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: March 6, 2023
• Study Start: November 17, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

IT (1)