Cross-sectional Study on Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students. A GENERATOR Infrastructure.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,040
- 试验地点
- 1
- 主要终点
- The prevalence of Latent Tuberculosis Infection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •denied informed consent.
结局指标
主要结局
The prevalence of Latent Tuberculosis Infection
时间窗: 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.
次要结局
- Age(At enrollment.)
- Occupation(At enrollment.)
- Working / training Unit(At enrollment.)
- QuantiFERON-TB(At enrollment.)
- Vaccination history(At enrollment.)
- Recent exposure(At enrollment.)
- Smoking(At enrollment.)
- Co-morbidities / medical history(At enrollment.)
- Sex(At enrollment.)
- Previous work or stay in other at risk countries(At enrollment.)
- Years working as HCW(At enrollment.)
研究者
Eleonora Nucera
Head of Allergy Unit
Catholic University of the Sacred Heart