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NCT Number: NCT05756582

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

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.

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Key information

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Roma, 00168, Italy

Location status: Recruiting

Location contact

Angela Rizzi, MD, PhD

CONTACT

[email protected]

+390630154965

Carlotta Masciocchi, Eng.

SUB_INVESTIGATOR

Chiara La Face, MD

SUB_INVESTIGATOR

Gabriele Rumi, MD

SUB_INVESTIGATOR

Giancarlo Scoppettuolo, MD

SUB_INVESTIGATOR

Luca Boldrini, MD

SUB_INVESTIGATOR

Michela Sali, MD

SUB_INVESTIGATOR

Raffaella Chini, MD

CONTACT

[email protected]

+390630154965

Raffaella Chini, MD

SUB_INVESTIGATOR

Riccardo Inchingolo, MD, PhD

SUB_INVESTIGATOR

Vincenzina Anzelmo, Prof., MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. The prevalence of Latent Tuberculosis Infection

    Time frame: 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.

Secondary outcomes

  1. Age

    Time frame: At enrollment.

    Age as possible risk factor of Latent Tuberculosis Infection.

  2. Sex

    Time frame: At enrollment.

    Sex as possible risk factor of Latent Tuberculosis Infection.

  3. Vaccination history

    Time frame: At enrollment.

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

  4. Previous work or stay in other at risk countries

    Time frame: At enrollment.

    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.

  5. Recent exposure

    Time frame: At enrollment.

    Known recent (within 6 months) exposure to TB-infected patient; as possible risk factor of Latent Tuberculosis Infection.

  6. Smoking

    Time frame: At enrollment.

    Current smoking as possible risk factor of Latent Tuberculosis Infection.

  7. Co-morbidities / medical history

    Time frame: At enrollment.

    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.

  8. QuantiFERON-TB

    Time frame: At enrollment.

    Median QuantiFERON-TB Gold In-Tube level (TB Ag-Nil) as possible risk factor of Latent Tuberculosis Infection.

  9. Occupation

    Time frame: At enrollment.

    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.

  10. Working / training Unit

    Time frame: At enrollment.

    Working / training Unit as possible risk factor of Latent Tuberculosis Infection.

  11. Years working as HCW

    Time frame: At enrollment.

    Years working as HCW as possible risk factor of Latent Tuberculosis Infection.

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Rizzi, MD, PhD

CONTACT

[email protected]

+390630154965

Raffaella Chini, MD

CONTACT

[email protected]

+390630154965

Sponsors and collaborators

Lead sponsor

Eleonora Nucera

Other

Registry information

Official study title

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

Acronym: CROSSWORD

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2023
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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