Actively Recruiting

Age: 18Years +
All Genders
ID06764576

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

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-08

13000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Tuberculosis (TB) has re-emerged as a public health concern in industrialized countries, with a decrease in incidence among residents but an increase among immigrants. Researchers are studying patients with TB, non-tubercular mycobacteriosis, or latent tuberculosis infection (ITBL) to better understand the disease's epidemiological, demographic, and clinical aspects. The study aims to improve rapid, reliable identification of active and latent infections and to assess diagnostic methods and patient outcomes. The study is observational and non-pharmacological, conducted at a single center. It includes a retrospective phase analyzing data from January 2012 to May 2021 and a prospective phase from June 2021 to December 2026. Data collected include biological samples for mycobacteria detection and blood samples for immunological testing of latent TB infection. The study evaluates diagnostic accuracy of microbiological and immunological methods and analyzes microbiological characteristics of TB and non-tubercular mycobacteria strains. Participants with suspected mycobacterial infection undergo clinical and radiological evaluation, with samples collected for laboratory tests. Researchers follow patients during treatment and post-treatment to assess clinical outcomes. The primary outcome measures include epidemiological and clinical features of patients from 2021 to 2026, while secondary outcomes focus on diagnostic method accuracy. The study duration covers several years, allowing long-term observation and follow-up of patient outcomes.

CONDITIONS

Brief Title

Patients With Tuberculosis, Mycobacteriosis or Latent Tuberculosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age of 18 years or more
  • Clinical or radiological suspicion of tuberculosis, non-tubercular mycobacteriosis, or latent tuberculosis infection
  • Submission of at least one biological sample for mycobacteria research and/or a blood sample for the IGRA test
  • Obtaining informed consent
Not Eligible

You will not qualify if you...

  • None

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Ongoing throughout the prospective phase from June 2021 to December 2026

Participants suspected of tuberculosis or mycobacteriosis undergo biological sample collection and immunological testing for diagnosis.

Visits as needed for sample collection and testing

Long-term Monitoring

Duration - Up to 6 years from June 2021 to December 2026

Participants are observed for clinical outcomes and epidemiological analysis during and after any treatment for tuberculosis, mycobacteriosis, or latent tuberculosis infection.

Follow-up visits depending on clinical care and study schedule

Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

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Research Team

P

Paola Dal Monte, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

British Thoracic Society guidelines for the management of non-tuberculous mycobacterial pulmonary disease (NTM-PD).

Charles S Haworth, John Banks, Toby Capstick...

https://pubmed.ncbi.nlm.nih.gov/29054853

Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis.

Payam Nahid, Susan E Dorman, Narges Alipanah...

https://pubmed.ncbi.nlm.nih.gov/27516382

Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study.

Susan E Dorman, Samuel G Schumacher, David Alland...

https://pubmed.ncbi.nlm.nih.gov/29198911