The Italian registry of pulmonary non-tuberculous mycobacteria - IRENE: The study protocol

IRENE Network, Stefano Aliberti, Luigi Ruffo Codecasa, Andrea Gori, Giovanni Sotgiu, Maura Spotti, Antonio Di Biagio, Andrea Calcagno, Stefano Nardini, Baroukh Maurice Assael, Enrico Tortoli, Giorgio Besozzi, Maurizio Ferrarese, Alberto Matteelli, Enrico Girardi, Saverio De Lorenzo, Manuela Seia, Andrea Gramegna, Bruno Del Prato, Leonardo TerranovaMartina Oriano, Nicola Sverzellati, Mehdi Mirsaeidi, James D. Chalmers, Charles S. Haworth, Michael R. Loebinger, Timothy Aksamit, Kevin Winthrop, Felix C. Ringshausen, Giuliana Previdi, Francesco Blasi

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Abstract

Background: A substantial increase in pulmonary and extra-pulmonary diseases due to non-tuberculous mycobacteria (NTM) has been documented worldwide, especially among subjects suffering from chronic respiratory diseases and immunocompromised patients. Many questions remain regarding the epidemiology of pulmonary disease due to NTM (NTM-PD) mainly because reporting of NTM-PD to health authorities is not mandated in several countries, including Italy. This manuscript describes the protocol of the first Italian registry of adult patients with respiratory infections caused by NTM (IRENE).

Methods: IRENE is an observational, multicenter, prospective, cohort study enrolling consecutive adult patients with either a NTM respiratory isolate or those with NTM-PD. A total of 41 centers, including mainly pulmonary and infectious disease departments, joined the registry so far. Adult patients with all of the following are included in the registry: 1) at least one positive culture for any NTM species from any respiratory sample; 2) at least one positive culture for NTM isolated in the year prior the enrolment and/or prescribed NTM treatment in the year prior the enrolment; 3) given consent to inclusion in the study. No exclusion criteria are applied to the study. Patients are managed according to standard operating procedures implemented in each IRENE clinical center. An online case report form has been developed to collect patients' demographics, comorbidities, microbiological, laboratory, functional, radiological, clinical, treatment and outcome data at baseline and on an annual basis. An IRENE biobank has also been developed within the network and linked to the clinical data of the registry.

Conclusions: IRENE has been developed to inform the clinical and scientific community on the current management of adult patients with NTM respiratory infections in Italy and acts as a national network to increase the disease's awareness.

Trial registration: Clinicaltrial.gov: NCT03339063.

Original languageEnglish
Article number33
Number of pages6
JournalMultidisciplinary Respiratory Medicine
Volume13
Issue numberSuppl. 1
DOIs
Publication statusPublished - 9 Aug 2018
Event2nd World Bronchiectasis Conference - Università degli Studi di Milano, Milan, Italy
Duration: 6 Jul 20178 Jul 2017
http://www.world-bronchiectasis-conference.org/

Keywords

  • Atypical mycobacteria
  • Bronchiectasis
  • COPD
  • Cystic fibrosis
  • HIV
  • Lung transplant
  • M. Avium
  • M. Intracellulare
  • NTM, NTM-PD

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    IRENE Network, Aliberti, S., Codecasa, L. R., Gori, A., Sotgiu, G., Spotti, M., Di Biagio, A., Calcagno, A., Nardini, S., Assael, B. M., Tortoli, E., Besozzi, G., Ferrarese, M., Matteelli, A., Girardi, E., De Lorenzo, S., Seia, M., Gramegna, A., Del Prato, B., ... Blasi, F. (2018). The Italian registry of pulmonary non-tuberculous mycobacteria - IRENE: The study protocol. Multidisciplinary Respiratory Medicine, 13(Suppl. 1), [33]. https://doi.org/10.1186/s40248-018-0141-8