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Идёт набор NCT05756582

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

— Наблюдательное Tuberculosis Tuberculosis, Pulmonary Tuberculosis Infection Latent Tuberculosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Prevalence of Latent Tuberculosis Infection.
Кому может быть актуально
Состояния в реестре: Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis Infection, Latent Tuberculosis. Базовые параметры: 18 лет — 72 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест 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 I

Первичные конечные точки

  • The prevalence of Latent Tuberculosis Infection [Срок оценки: At enrollment.]
Вторичные конечные точки (11)
  • Age [Срок оценки: At enrollment.]
  • Sex [Срок оценки: At enrollment.]
  • Vaccination history [Срок оценки: At enrollment.]
  • Previous work or stay in other at risk countries [Срок оценки: At enrollment.]
  • Recent exposure [Срок оценки: At enrollment.]
  • Smoking [Срок оценки: At enrollment.]
  • Co-morbidities / medical history [Срок оценки: At enrollment.]
  • QuantiFERON-TB [Срок оценки: At enrollment.]
  • Occupation [Срок оценки: At enrollment.]
  • Working / training Unit [Срок оценки: At enrollment.]
  • Years working as HCW [Срок оценки: At enrollment.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • denied informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Италия · 1 центр
  • UOSD Allergologia e Immunologia Clinica, Fondazione Policlinico Universitario A. Gemelli I — Roma

Публикации

  • 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 w PMID 40132007

Идентификаторы

NCT: NCT05756582 · ID3528

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗