TuberculosisCROSSWORDNCT05756582
Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students
An observational study of Tuberculosis and Tuberculosis, Pulmonary, run by Eleonora Nucera at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis Infection
- What is being tested?
- Prevalence of Latent Tuberculosis Infection
- How many people
- 2,040 participants
- Where
- 1 siteItaly
- Study dates
- 17 Nov 2021to 15 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- denied informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
UOSD Allergologia e Immunologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Angela Rizzi, MD, PhD, +390630154965, angela.rizzi@policlinicogemelli.it
Raffaella Chini, MD, +390630154965, raffaella.chini@guest.policlinicogemelli.it
About this study
Official title: Cross-sectional Study on Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students. A GENERATOR Infrastructure.
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.
Read the 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.
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis Infection, Latent Tuberculosis, Health Care Associated Infection
- Being tested
- Prevalence of Latent Tuberculosis Infection
- Keywords
- latent tuberculosis infection, health-care workers, students, survey
- Medical subject headings
- Tuberculosis, Tuberculosis, Pulmonary, Latent Tuberculosis, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevalence of Latent Tuberculosis InfectionDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Prevalence of Latent Tuberculosis Infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment.
Secondary outcomes (11)
Age
Age as possible risk factor of Latent Tuberculosis Infection.
Measured: At enrollment.
Sex
Sex as possible risk factor of Latent Tuberculosis Infection.
Measured: At enrollment.
Vaccination history
Bacillus Calmette-Guérin (BCG) vaccination history as possible risk factor of Latent Tuberculosis Infection.
Measured: At enrollment.
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.
Measured: At enrollment.
Recent exposure
Known recent (within 6 months) exposure to TB-infected patient; as possible risk factor of Latent Tuberculosis Infection.
Measured: At enrollment.
Smoking
Current smoking as possible risk factor of Latent Tuberculosis Infection.
Measured: At enrollment.
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.
Measured: At enrollment.
QuantiFERON-TB
Median QuantiFERON-TB Gold In-Tube level (TB Ag-Nil) as possible risk factor of Latent Tuberculosis Infection.
Measured: At enrollment.
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.
Measured: At enrollment.
Working / training Unit
Working / training Unit as possible risk factor of Latent Tuberculosis Infection.
Measured: At enrollment.
Years working as HCW
Years working as HCW as possible risk factor of Latent Tuberculosis Infection.
Measured: At enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start17 Nov 2021
- Primary completion30 Jun 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eleonora Nucera
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eleonora Nucera, Catholic University of the Sacred Heart
- Investigators
- Angela Rizzi, MD, PhD, Principal investigator, Catholic University of Sacred HeartEleonora G Nucera, Prof., MD, Principal investigator, Catholic University of Sacred HeartDomenico Staiti, Prof., MD, Principal investigator, Catholic University of Sacred HeartAntonio Gasbarrini, Prof., MD, Study director, Catholic University of Sacred HeartVincenzo Valentini, Prof., MD, Study director, Catholic University of Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756582
- Sponsor's protocol ID
- ID3528
- Acronym
- CROSSWORD
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rizzi A, Nucera E, Mazzucco W, Palumbo P, Staiti D, Moscato U, De Simone FM, Sali M, Boldrini L, Capocchiano ND, Patarnello S, Rumi G, Chini R, Carusi V, Centrone M, Di Rienzo A, Longhino D, Laface C, Mellone S, Maida CM, Cannizzaro E, Cirrincione L, Verso MG, Saracino A, Di Gennaro F, Vimercati L, De Maria L, Sponselli S, Scoppettuolo G, Pastorino R, Gasbarrini A, Inchingolo R. An interoperable web-based platform to support health surveillance against latent tuberculosis infection in health care workers and students: The evolution of CROSSWORD study protocol. PLoS One. 2025 Mar 25;20(3):e0319568. doi: 10.1371/journal.pone.0319568. eCollection 2025.
PubMed 40132007