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

Sponsor
Eleonora Nucera (Other)
Overall Status
Recruiting
CT.gov ID
NCT05756582
Collaborator
(none)
2,040
1
18.9
108

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Prevalence of Latent Tuberculosis Infection

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
2040 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Cross-sectional Study on Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students. A GENERATOR Infrastructure.
Actual Study Start Date :
Nov 17, 2021
Anticipated Primary Completion Date :
Jun 15, 2023
Anticipated Study Completion Date :
Jun 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Health-care workers and students

The study will involve all health-care workers 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.

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-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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Secondary Outcome Measures

  1. Age [At enrollment.]

    Age as possible risk factor of Latent Tuberculosis Infection.

  2. Sex [At enrollment.]

    Sex as possible risk factor of Latent Tuberculosis Infection.

  3. Vaccination history [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 [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 [At enrollment.]

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

  6. Smoking [At enrollment.]

    Current smoking as possible risk factor of Latent Tuberculosis Infection.

  7. Co-morbidities / medical history [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 [At enrollment.]

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

  9. Occupation [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 [At enrollment.]

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

  11. Years working as HCW [At enrollment.]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 72 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UOSD Allergologia e Immunologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS Roma Italy 00168

Sponsors and Collaborators

  • Eleonora Nucera

Investigators

  • Principal Investigator: Angela Rizzi, MD, PhD, Catholic University of Sacred Heart
  • Principal Investigator: Eleonora G Nucera, Prof., MD, Catholic University of Sacred Heart
  • Principal Investigator: Domenico Staiti, Prof., MD, Catholic University of Sacred Heart
  • Study Director: Antonio Gasbarrini, Prof., MD, Catholic University of Sacred Heart
  • Study Director: Vincenzo Valentini, Prof., MD, Catholic University of Sacred Heart

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eleonora Nucera, Head of Allergy Unit, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT05756582
Other Study ID Numbers:
  • ID3528
First Posted:
Mar 6, 2023
Last Update Posted:
Mar 6, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eleonora Nucera, Head of Allergy Unit, Catholic University of the Sacred Heart
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 6, 2023