NCT Number: NCT06764576
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Bologna, 40138, Italy
Location status: Recruiting
Francesco Bisognin
SUB_INVESTIGATOR
Giulia Lombardi
SUB_INVESTIGATOR
Marina Tadolini, PhD
SUB_INVESTIGATOR
Paola Dal Monte, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: from 2021 to 2026
Patients' data with biological samples for mycobacteria research and/or blood samples for immunological investigations for latent tubercular infection and clinical/radiological suspicion of mycobacteriosis or tuberculosis had been colleted from January 2012 to May 2021 (retrospective phase of the study) and from June 2021 to December 2026 (prospective phase of the study). The criteria for diagnosis of TB confirmed microbiologically are: Clinical+Imaging suggestive of tuberculosis disease;microbiological isolation of MTB and/ or molecular test for MTB (Xpert) positive;decision of the clinician to start anti-tuberculosis treatment. The criteria for diagnosing non-tubercular mycobacteriosis are: Clinical+Imaging suggestive of mycobacteriosis;isolation of NTM from at least two sputum samples or one bronchocolagement sample. The criteria for diagnosing ITBL are: positive IGRA and/or positive TST test;absence of clinical/radiological signs of tubercular disease.
Time frame: from 2021 to 2026
Patients' data with biological samples for mycobacteria research and/or blood samples for immunological investigations for latent tubercular infection and clinical/radiological suspicion of mycobacteriosis or tuberculosis had been colleted from January 2012 to May 2021 (retrospective phase of the study) and from June 2021 to December 2026 (prospective phase of the study). The criteria for diagnosis of TB confirmed microbiologically are: Clinical+Imaging suggestive of tuberculosis disease;microbiological isolation of MTB and/ or molecular test for MTB (Xpert) positive;decision of the clinician to start anti-tuberculosis treatment. The criteria for diagnosing non-tubercular mycobacteriosis are: Clinical+Imaging suggestive of mycobacteriosis;isolation of NTM from at least two sputum samples or one bronchocolagement sample. The criteria for diagnosing ITBL are: positive IGRA and/or positive TST test;absence of clinical/radiological signs of tubercular disease.
Time frame: from 2021 to 2026
Patients' data with biological samples for mycobacteria research and/or blood samples for immunological investigations for latent tubercular infection and clinical/radiological suspicion of mycobacteriosis or tuberculosis had been colleted from January 2012 to May 2021 (retrospective phase of the study) and from June 2021 to December 2026 (prospective phase of the study). The criteria for diagnosis of TB confirmed microbiologically are: Clinical+Imaging suggestive of tuberculosis disease;microbiological isolation of MTB and/ or molecular test for MTB (Xpert) positive;decision of the clinician to start anti-tuberculosis treatment. The criteria for diagnosing non-tubercular mycobacteriosis are: Clinical+Imaging suggestive of mycobacteriosis;isolation of NTM from at least two sputum samples or one bronchocolagement sample. The criteria for diagnosing ITBL are: positive IGRA and/or positive TST test;absence of clinical/radiological signs of tubercular disease.
Time frame: from 2021 to 2026
Patients' data with biological samples for mycobacteria research and/or blood samples for immunological investigations for latent tubercular infection and clinical/radiological suspicion of mycobacteriosis or tuberculosis had been colleted from January 2012 to May 2021 (retrospective phase of the study) and from June 2021 to December 2026 (prospective phase of the study). The criteria for diagnosis of TB confirmed microbiologically are: Clinical+Imaging suggestive of tuberculosis disease;microbiological isolation of MTB and/ or molecular test for MTB (Xpert) positive;decision of the clinician to start anti-tuberculosis treatment. The criteria for diagnosing non-tubercular mycobacteriosis are: Clinical+Imaging suggestive of mycobacteriosis;isolation of NTM from at least two sputum samples or one bronchocolagement sample. The criteria for diagnosing ITBL are: positive IGRA and/or positive TST test;absence of clinical/radiological signs of tubercular disease.
Contact information is provided by the study sponsor or research team.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
Epidemiological, Demographic and Clinical Aspects of Patients With Tuberculosis, Mycobacteriosis or Infection Latent Tuberculosis
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