Observing patients with tuberculosis and related infections
Epidemiological, Demographic and Clinical Aspects of Patients With Tuberculosis, Mycobacteriosis or Infection Latent Tuberculosis
This study looks at patients suspected of having tuberculosis or related infections to see how these conditions affect them and how well different tests work to diagnose them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 13000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06764576 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with clinical or radiological suspicion of tuberculosis (TB), non-tubercular mycobacteriosis, or latent tuberculosis infection (ITBL). It involves a retrospective analysis of data from January 2012 to May 2021, as well as a prospective analysis from June 2021 to December 2026. The study aims to assess the epidemiological, demographic, and clinical aspects of these patients, evaluate the diagnostic accuracy of various methods for TB and mycobacterial infections, and analyze the microbiological characteristics of the strains involved. The outcomes will help improve understanding and management of TB and related infections.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older with a clinical or radiological suspicion of TB, non-tubercular mycobacteriosis, or latent tuberculosis infection.
Not a fit: Patients without any clinical or radiological suspicion of TB or related infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnosis and treatment of tuberculosis and related infections, ultimately improving patient outcomes.
How similar studies have performed: Other studies have shown success in identifying and managing tuberculosis and mycobacterial infections, making this approach relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Paola Dal Monte, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Paola Dal Monte, MD
- Email: paola.dalmonte@unibo.it
- Phone: 0390512145293
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.