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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07485868

Acronym

SCORE-TB

Enrollment

686

Registered

2026-03-20

Start date

2026-04-01

Completion date

2030-04-01

Last updated

2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Brief 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.

Interventions

OTHERDevelopment 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
construction of a logistic regression model	5 years	construction of a logistic regression model based on clinical and epidemiological variables significantly associated with pulmonary tuberculosis

Contacts

CONTACTAntonella Cingolani, Dr

antonella.cingolani@policlinicogemelli.it00390630154945

CONTACTPaola Del Giacomo, Dr

paola.delgiacomo@policlinicogemelli.it00390630154945

PRINCIPAL_INVESTIGATORAntonella Cingolani

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026