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Recruiting Observational

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

NCT05756582 · tracked via the Priya Life Science Italy tracker
Sponsor
Eleonora Nucera
Phase
Observational
Started
2021-11-17
Last updated
2024-02-13

Condition(s) studied

TuberculosisTuberculosis, PulmonaryTuberculosis InfectionLatent TuberculosisHealth Care Associated Infection

Investigational drug(s) / intervention(s)

Prevalence of Latent Tuberculosis Infection

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
72 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
UOSD Allergologia e Immunologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS Roma Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05756582 on ClinicalTrials.gov ↗ ← All trials in Italy