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NOT YET RECRUITING
NCT07485868

Development of a Clinical-epidemiological Score Predictive of Tuberculosis.

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

686

Start Date

2026-04-01

Completion Date

2030-04-01

Last Updated

2026-03-20

Healthy Volunteers

No

Conditions

Interventions

OTHER

Development and validation of a clinical-epidemiological predictive score for the diagnosis of pulmonary tuberculosis

Development and validation of a clinical-epidemiological predictive score for the diagnosis of pulmonary tuberculosis. External validation through surveys on clinicians