Patients With Tuberculosis, Mycobacteriosis or Latent Tuberculosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
13,000 Participants
are grouped into 3 trial groupsGroup A: Tuberculosis or mycobacteriosis Microbiologically confirmed cases
Group B: Latent tuberculosis infection cases
Group C: Patients with suspected tuberculosis, non-tubercular mycobacteriosis or tubercular infection
Trial outcomes
Primary outcomes
1
Analysis of epidemiological, demographic and clinical aspects of patients with tuberculosis, mycobacteriosis non-tubercular or latent tubercular infection
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 2026Secondary outcomes
1
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).
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 2026Other outcomes
1
Analysis of the microbiological characteristics (phenotypic and molecular) of MTB and NTM.
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 20262
Evaluation of the clinical outcome of patients with ITBL/TB/NTM in treatment and follow-up in post-processing period.
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 2026Sponsors and contacts
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Source ClinicalTrials.gov