Development of a Clinical-epidemiological Score Predictive of Tuberculosis.

NCT07485868 | Not Yet Recruiting

• 1 other identifier: 15560
• Study Type: observational
• Target: 686
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• construction of a logistic regression model

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

  5 years

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with clinically suspected tuberculosis Infectious disease specialists and emergency room physicians

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Tuberculosis

Interventions

Growth and Development

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Physiological Phenomena

Study Officials

• Antonella Cingolani

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonella Cingolani, Dr

CONTACT

00390630154945; antonella.cingolani@policlinicogemelli.it

Paola Del Giacomo, Dr

CONTACT

00390630154945; paola.delgiacomo@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share