Patients With Tuberculosis, Mycobacteriosis or Latent Tuberculosis

NCT06764576 | Recruiting

• 1 other identifier: Micro-TB
• Study Type: observational
• Target: 13,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Mycobacterial Infection; Tuberculosis (TB)

Keywords

infection; mycobacterial; tuberculosis; diagnosis; latent tuberculosis infection; mycobacterial non-tubercular; microbiological tests

Outcome Measures

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.

  from 2021 to 2026

Secondary 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).

  from 2021 to 2026

Other Outcomes (2)

• Analysis of the microbiological characteristics (phenotypic and molecular) of MTB and NTM.

  from 2021 to 2026

• Evaluation of the clinical outcome of patients with ITBL/TB/NTM in treatment and follow-up in post-processing period.

  from 2021 to 2026

Study Arms (3)

Tuberculosis or mycobacteriosis Microbiologically confirmed cases

Retrospective phase from 1 January 2012 to 31 May 2021

Latent tuberculosis infection cases

Retrospective phase, patients followed by infectious diseases clinics from 2017 to May 2021

Patients with suspected tuberculosis, non-tubercular mycobacteriosis or tubercular infection

Prospective phase from 1 June 2021 to 31 December 2026

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Related Publications (11)

• Haworth CS, Banks J, Capstick T, Fisher AJ, Gorsuch T, Laurenson IF, Leitch A, Loebinger MR, Milburn HJ, Nightingale M, Ormerod P, Shingadia D, Smith D, Whitehead N, Wilson R, Floto RA. British Thoracic Society guidelines for the management of non-tuberculous mycobacterial pulmonary disease (NTM-PD). Thorax. 2017 Nov;72(Suppl 2):ii1-ii64. doi: 10.1136/thoraxjnl-2017-210927. No abstract available.

  PMID: 29054853 BACKGROUND

• Nahid P, Dorman SE, Alipanah N, Barry PM, Brozek JL, Cattamanchi A, Chaisson LH, Chaisson RE, Daley CL, Grzemska M, Higashi JM, Ho CS, Hopewell PC, Keshavjee SA, Lienhardt C, Menzies R, Merrifield C, Narita M, O'Brien R, Peloquin CA, Raftery A, Saukkonen J, Schaaf HS, Sotgiu G, Starke JR, Migliori GB, Vernon A. Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis. Clin Infect Dis. 2016 Oct 1;63(7):e147-e195. doi: 10.1093/cid/ciw376. Epub 2016 Aug 10.

  PMID: 27516382 BACKGROUND

• Petrucci R, Lombardi G, Corsini I, Bacchi Reggiani ML, Visciotti F, Bernardi F, Landini MP, Cazzato S, Dal Monte P. Quantiferon-TB Gold In-Tube Improves Tuberculosis Diagnosis in Children. Pediatr Infect Dis J. 2017 Jan;36(1):44-49. doi: 10.1097/INF.0000000000001350.

  PMID: 27749653 BACKGROUND

• Barcellini L, Borroni E, Brown J, Brunetti E, Codecasa L, Cugnata F, Dal Monte P, Di Serio C, Goletti D, Lombardi G, Lipman M, Rancoita PM, Tadolini M, Cirillo DM. First independent evaluation of QuantiFERON-TB Plus performance. Eur Respir J. 2016 May;47(5):1587-90. doi: 10.1183/13993003.02033-2015. Epub 2016 Feb 11. No abstract available.

  PMID: 26869677 BACKGROUND

• Dorman SE, Schumacher SG, Alland D, Nabeta P, Armstrong DT, King B, Hall SL, Chakravorty S, Cirillo DM, Tukvadze N, Bablishvili N, Stevens W, Scott L, Rodrigues C, Kazi MI, Joloba M, Nakiyingi L, Nicol MP, Ghebrekristos Y, Anyango I, Murithi W, Dietze R, Lyrio Peres R, Skrahina A, Auchynka V, Chopra KK, Hanif M, Liu X, Yuan X, Boehme CC, Ellner JJ, Denkinger CM; study team. Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study. Lancet Infect Dis. 2018 Jan;18(1):76-84. doi: 10.1016/S1473-3099(17)30691-6. Epub 2017 Nov 30.

  PMID: 29198911 BACKGROUND

• Lombardi G, Di Gregori V, Girometti N, Tadolini M, Bisognin F, Dal Monte P. Diagnosis of smear-negative tuberculosis is greatly improved by Xpert MTB/RIF. PLoS One. 2017 Apr 21;12(4):e0176186. doi: 10.1371/journal.pone.0176186. eCollection 2017.

  PMID: 28430807 BACKGROUND

• Internal Clinical Guidelines Team (UK). Tuberculosis: Prevention, Diagnosis, Management and Service Organisation. London: National Institute for Health and Care Excellence (UK); 2016 Jan. Available from http://www.ncbi.nlm.nih.gov/books/NBK338750/

  PMID: 26820019 BACKGROUND

• Jensen PA, Lambert LA, Iademarco MF, Ridzon R; CDC. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005. MMWR Recomm Rep. 2005 Dec 30;54(RR-17):1-141.

  PMID: 16382216 BACKGROUND

• Aliberti S, Codecasa LR, Gori A, Sotgiu G, Spotti M, Di Biagio A, Calcagno A, Nardini S, Assael BM, Tortoli E, Besozzi G, Ferrarese M, Matteelli A, Girardi E, De Lorenzo S, Seia M, Gramegna A, Del Prato B, Terranova L, Oriano M, Sverzellati N, Mirsaeidi M, Chalmers JD, Haworth CS, Loebinger MR, Aksamit T, Winthrop K, Ringshausen FC, Previdi G, Blasi F; IRENE Network. The Italian registry of pulmonary non-tuberculous mycobacteria - IRENE: the study protocol. Multidiscip Respir Med. 2018 Aug 9;13(Suppl 1):33. doi: 10.1186/s40248-018-0141-8. eCollection 2018.

  PMID: 30151192 BACKGROUND

• Fattorini L, Mustazzolu A, Borroni E, Piccaro G, Giannoni F, Cirillo DM; Italian Multicentre Study on Resistance to Antituberculosis Drugs (SMIRA) Group. Tuberculosis in migrants from 106 countries to Italy, 2008-2014. Eur Respir J. 2016 Apr;47(4):1273-6. doi: 10.1183/13993003.01844-2015. Epub 2016 Feb 4. No abstract available.

  PMID: 26846829 BACKGROUND

• Lombardi G, Dal Monte P, Denicolo A, Tadolini M, Martelli G, Bacchi Reggiani ML, Viale P, Landini MP. Trend of microbiologically-confirmed tuberculosis in a low-incidence setting with high immigration rates. BMC Public Health. 2014 Apr 10;14:340. doi: 10.1186/1471-2458-14-340.

  PMID: 24721236 BACKGROUND

Related Links

• Agenzia Sanitaria e Sociale Regionale della Regione Emilia-Romagna. Epidemiologia della tubercolosi in Emilia-Romagna 2010-11.
• World Health Organization. Guidelines for the treatment of drug-susceptible tuberculosis and patient care (2017 update)

Biospecimen

Retention: SAMPLES WITH DNA

blood, sputum or broncholavage samples

MeSH Terms

Conditions

Mycobacterium Infections; Tuberculosis; Infections; Disease; Latent Tuberculosis

Condition Hierarchy (Ancestors)

Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Latent Infection

Study Officials

• Paola Dal Monte, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Dal Monte, MD

CONTACT

0390512145293; paola.dalmonte@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: December 19, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 8, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)