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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05756582
Other study ID # ID3528
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 17, 2021
Est. completion date December 15, 2026

Study information

Verified date February 2024
Source Catholic University of the Sacred Heart
Contact Angela Rizzi, MD, PhD
Phone +390630154965
Email angela.rizzi@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2040
Est. completion date December 15, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 72 Years
Eligibility 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.

Study Design


Intervention

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-? 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.

Locations

Country Name City State
Italy UOSD Allergologia e Immunologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS Roma

Sponsors (1)

Lead Sponsor Collaborator
Eleonora Nucera

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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-? 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 Age Age as possible risk factor of Latent Tuberculosis Infection. At enrollment.
Secondary Sex Sex as possible risk factor of Latent Tuberculosis Infection. At enrollment.
Secondary Vaccination history Bacillus Calmette-Guérin (BCG) vaccination history as possible risk factor of Latent Tuberculosis Infection. At enrollment.
Secondary 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. At enrollment.
Secondary Recent exposure Known recent (within 6 months) exposure to TB-infected patient; as possible risk factor of Latent Tuberculosis Infection. At enrollment.
Secondary Smoking Current smoking as possible risk factor of Latent Tuberculosis Infection. At enrollment.
Secondary Co-morbidities / medical history Co-morbidities / medical history [HIV, diabetes, silicosis, chronic kidney disease, solid organ transplant, malignant hematologic malignancies or undergoing chemotherapy, gastrectomy or fasting bypass, biological drugs]; as possible risk factor of Latent Tuberculosis Infection. At enrollment.
Secondary QuantiFERON-TB Median QuantiFERON-TB Gold In-Tube level (TB Ag-Nil) as possible risk factor of Latent Tuberculosis Infection. At enrollment.
Secondary Occupation Occupation [doctor, nurse, laboratory technicians, paramedical personnel, "preclinical" students with no contact with patients inside the hospital, and "clinical" students attending various medical, laboratory, and surgical departments of the hospital, including the infectious disease wards] as possible risk factor of Latent Tuberculosis Infection. At enrollment.
Secondary Working / training Unit Working / training Unit as possible risk factor of Latent Tuberculosis Infection. At enrollment.
Secondary Years working as HCW Years working as HCW as possible risk factor of Latent Tuberculosis Infection. At enrollment.
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