跳至主要内容
临床试验/NCT07485868
NCT07485868尚未招募不适用

Creation of a Cohort of Patients With Tuberculosis or Suspected Tuberculosis Admitted to a University Hospital in a Low-endemic Setting, Development of a Clinical-epidemiological Score Predictive of Tuberculosis, Optimization of the Diagnostic-therapeutic Pathway.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 个研究点目标入组 686 人开始时间: 2026年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
686
主要终点
construction of a logistic regression model

研究概览

简要总结

Despite being a curable and preventable disease, tuberculosis still represents a major global health problem. It is estimated that 10.8 million people contracted tuberculosis in 2023, with an incidence of 134 per 100,000 inhabitants. In 2023, there were 1.25 million deaths, confirming this disease as a leading cause of death and the leading cause of death from a single infectious agent. It is a disease that primarily affects adults in their most productive years, with significant repercussions on family budgets. The aim of this study is to identify and characterize the demographic, epidemiological, microbiological, clinical, and radiological variables of the tuberculosis population that has come to our hospital's attention, as an exemplary population in a low-endemic setting. This study also aims to develop a tuberculosis risk score aimed at early differentiation between patients requiring respiratory isolation and those with negligible tuberculosis risk, and to improve diagnostic accuracy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • atients aged ≥18 years;
  • Patients hospitalized during the study period who, due to a clinical suspicion of tuberculosis, underwent diagnostic tests on respiratory samples (sputum, induced sputum, tracheal aspirate, bronchoalveolar lavage) at the Fondazione Policlinico Universitario "A. Gemelli" IRCCS.
  • Informed consent will be obtained for prospective patients, while for retrospective patients, reference will be made to Article 110-bis of the Privacy Code.

排除标准

  • Patients <18 years of age;
  • Patient already included (each patient will be included only once, regardless of the number of isolations).

结局指标

主要结局

construction of a logistic regression model

时间窗: 5 years

construction of a logistic regression model based on clinical and epidemiological variables significantly associated with pulmonary tuberculosis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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