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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-72
SponsorEleonora Nucera

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

denied informed consent.

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

2,040 Participants
are divided into 1 treatment group
Group A: Health-care workers and students1 intervention

Trial outcomes

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.

Time frame
At enrollment.

Secondary outcomes

1

Age

Age as possible risk factor of Latent Tuberculosis Infection.

Time frame
At enrollment.
2

Sex

Sex as possible risk factor of Latent Tuberculosis Infection.

Time frame
At enrollment.
3

Vaccination history

Bacillus Calmette-Guérin (BCG) vaccination history as possible risk factor of Latent Tuberculosis Infection.

Time frame
At enrollment.
4

Previous work or stay in other at risk countries

Previous work or stay in other countries with high TB rates including Armenia, Azerbaijan, Belarus, Bulgaria, Estonia, Georgia, Kazakhstan, Kyrgyzstan, Latvia, Lithuania, Moldova, Romania, Russia, Tajikistan, Turkey, Turkmenistan, Ukraine and Uzbekistan; as possible risk factor of Latent Tuberculosis Infection.

Time frame
At enrollment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eleonora Nucera

Lead sponsor

Catholic University of the Sacred Heart

Sponsor institution