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

Tuberculosis Clinical Trial

— CROSSWORD  

Official title:

Cross-sectional Study on Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students. A GENERATOR Infrastructure.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05756582
• Other study ID #: ID3528
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Health Care Associated Infection
• Infections
• Latent Tuberculosis
• Tuberculosis
• Tuberculosis Infection
• Tuberculosis, Pulmonary

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.