Clinical trial NCT06764576: Patients With Tuberculosis, Mycobacteriosis or Latent Tuberculosis
Official title: Epidemiological, Demographic and Clinical Aspects of Patients With Tuberculosis, Mycobacteriosis or Infection Latent Tuberculosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mycobacterial Infection
Tuberculosis (TB)
Keywords: infection
mycobacterial
tuberculosis
diagnosis
latent tuberculosis infection
mycobacterial non-tubercular
microbiological tests
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 13000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For the retrospective phase: TB or mycobacteriosis cases confirmed and ITBL cases followed by Infectious Disease Unit.

For the prospective phase: TB, non-tubercular mycobacteriosis or ITBL patients with suspicion.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* age of 18 years or more,
* clinical/radiological suspicion of TB or non-tubercular mycobacteriosis or ITBL for which sent to the Microbiology laboratory at least one biological sample for the mycobacteria and/or a blood sample for the IGRA test;
* Obtaining informed consent.

Exclusion Criteria:

* None

Primary outcomes:
measure: Analysis of epidemiological, demographic and clinical aspects of patients with tuberculosis, mycobacteriosis non-tubercular or latent tubercular infection
timeFrame: from 2021 to 2026
Secondary outcomes:
measure: Assessment of the 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).
timeFrame: from 2021 to 2026
Other outcomes:
measure: Analysis of the microbiological characteristics (phenotypic and molecular) of MTB and NTM.
timeFrame: from 2021 to 2026
measure: Evaluation of the clinical outcome of patients with ITBL/TB/NTM in treatment and follow-up in post-processing period.
timeFrame: from 2021 to 2026
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Paola Dal Monte, MD
role: PRINCIPAL_INVESTIGATOR
References:
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