Patients With Tuberculosis, Mycobacteriosis or Latent Tuberculosis

Official title

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

Overview

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.

Detailed description

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.

Primary outcome measures

• Analysis of epidemiological, demographic and clinical aspects of patients with tuberculosis, mycobacteriosis non-tubercular or latent tubercular infection [Time frame: from 2021 to 2026]

Secondary outcome measures (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). [Time frame: from 2021 to 2026]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 1 center

• IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna

Publications

• 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
• 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/Infectiou PMID 27516382
• 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
• 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
• 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 PMID 29198911
• 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
• 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
• 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

Identifiers

NCT: NCT06764576 · Micro-TB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗