NCT06764576

Patients With Tuberculosis, Mycobacteriosis or Latent Tuberculosis

Epidemiological, Demographic and Clinical Aspects of Patients With Tuberculosis, Mycobacteriosis or Infection Latent Tuberculosis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 13,000 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In the last 30 years, tuberculosis (TB) has re-emerged in industrialised countries as a public health, with a decrease in incidence among the resident population and an increase in the burden of immigrants. Therefore, it becomes a priority to implement an effective TB control that relies on both rapid and reliable identification of active infections, with a adequate treatment and surveillance of resistance, but also on the identification of latent tuberculosis infections (ITBL) in populations at higher risk of progression to the active disease, representing a source of infection for the community.

Detailed description

The study is non-pharmacological and monocentric. Data from patients with clinical/radiological suspicion of mycobacteriosis or tuberculosis will be considered for which they have been received at the OU of Microbiology of the Polyclinic S.Orsola-Malpighi biological samples for mycobacteria research and/or blood samples for immunological investigations for latent tubercular infection in the period January 2012-May 2021 (retrospective part of the study); Data from patients suspected of mycobacteriosis, TB or ITBL from June 2021 to December 2026 (prospective part of the study, duration: 6 years, possibly renewable) will also be considered. The objectives of the study are: 1) Analysis of epidemiological, demographic and clinical aspects of patients with TB, mycobacteriosis non-tubercular or ITBL in the period January 2012-December 2026. 2) Assessment of diagnostic accuracy of the most frequently used methods for Microbiological diagnosis of tuberculosis (TB) or non-tubercular mycobacteriosis and immunological methods for the diagnosis of latent tubercular infection (ITBL). 3) Analysis of the microbiological characteristics (phenotypic and molecular) of MTB and NTM strains. 4) Evaluation of the clinical outcome of patients with ITBL/TB/NTM in treatment and follow-up in the post-treatment period.

Conditions

• Mycobacterial Infection
• Tuberculosis (TB)

Timeline

• Start date: 2021-12-19
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-01-08
• Last updated: 2025-01-08

Locations

1 site across 1 country: Italy