NCT07485868

Development of a Clinical-epidemiological Score Predictive of Tuberculosis.

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.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 686 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-04-01
• Completion: 2030-04-01
• First posted: 2026-03-20
• Last updated: 2026-03-20