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 Terranova & 11 others Martina 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

Research output: Contribution to journalArticle

1 Citation (Scopus)
5 Downloads (Pure)

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/

Fingerprint

Mycobacterium
Registries
Lung
Lung Diseases
Respiratory Tract Infections
Italy
Mycobacterium Infections
Immunocompromised Host
Communicable Diseases
Comorbidity
Epidemiology
Chronic Disease
Cohort Studies
Demography
Prospective Studies
Health

Keywords

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

Cite this

IRENE Network, Aliberti, S., Codecasa, L. R., Gori, A., Sotgiu, G., Spotti, M., ... 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
IRENE Network ; Aliberti, Stefano ; Codecasa, Luigi Ruffo ; Gori, Andrea ; Sotgiu, Giovanni ; Spotti, Maura ; Di Biagio, Antonio ; Calcagno, Andrea ; Nardini, Stefano ; Assael, Baroukh Maurice ; Tortoli, Enrico ; Besozzi, Giorgio ; Ferrarese, Maurizio ; Matteelli, Alberto ; Girardi, Enrico ; De Lorenzo, Saverio ; Seia, Manuela ; Gramegna, Andrea ; Del Prato, Bruno ; Terranova, Leonardo ; Oriano, Martina ; Sverzellati, Nicola ; Mirsaeidi, Mehdi ; Chalmers, James D. ; Haworth, Charles S. ; Loebinger, Michael R. ; Aksamit, Timothy ; Winthrop, Kevin ; Ringshausen, Felix C. ; Previdi, Giuliana ; Blasi, Francesco. / The Italian registry of pulmonary non-tuberculous mycobacteria - IRENE : The study protocol. In: Multidisciplinary Respiratory Medicine. 2018 ; Vol. 13, No. Suppl. 1.
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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.",
keywords = "Atypical mycobacteria, Bronchiectasis, COPD, Cystic fibrosis, HIV, Lung transplant, M. Avium, M. Intracellulare, NTM, NTM-PD",
author = "{IRENE Network} and Stefano Aliberti and Codecasa, {Luigi Ruffo} and Andrea Gori and Giovanni Sotgiu and Maura Spotti and {Di Biagio}, Antonio and Andrea Calcagno and Stefano Nardini and Assael, {Baroukh Maurice} and Enrico Tortoli and Giorgio Besozzi and Maurizio Ferrarese and Alberto Matteelli and Enrico Girardi and {De Lorenzo}, Saverio and Manuela Seia and Andrea Gramegna and {Del Prato}, Bruno and Leonardo Terranova and Martina Oriano and Nicola Sverzellati and Mehdi Mirsaeidi and Chalmers, {James D.} and Haworth, {Charles S.} and Loebinger, {Michael R.} and Timothy Aksamit and Kevin Winthrop and Ringshausen, {Felix C.} and Giuliana Previdi and Francesco Blasi and Giuliana Fusetti and Manuela Martorana and Gennaro Colella and Giuseppina Verga and Gerardina Carbone and Isabella Damilano and Fabrizio Nava and Lisa Pancini and Ana Pasat and Nicol{\`o} Vanoni",
year = "2018",
month = "8",
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doi = "10.1186/s40248-018-0141-8",
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IRENE Network, 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 2018, 'The Italian registry of pulmonary non-tuberculous mycobacteria - IRENE: The study protocol', Multidisciplinary Respiratory Medicine, vol. 13, no. Suppl. 1, 33. https://doi.org/10.1186/s40248-018-0141-8

The Italian registry of pulmonary non-tuberculous mycobacteria - IRENE : The study protocol. / IRENE Network; Aliberti, Stefano; Codecasa, Luigi Ruffo; Gori, Andrea; Sotgiu, Giovanni; Spotti, Maura; Di Biagio, Antonio; Calcagno, Andrea; Nardini, Stefano; Assael, Baroukh Maurice; Tortoli, Enrico; Besozzi, Giorgio; Ferrarese, Maurizio; Matteelli, Alberto; Girardi, Enrico; De Lorenzo, Saverio; Seia, Manuela; Gramegna, Andrea; Del Prato, Bruno; Terranova, Leonardo; Oriano, Martina; Sverzellati, Nicola; Mirsaeidi, Mehdi; Chalmers, James D.; Haworth, Charles S.; Loebinger, Michael R.; Aksamit, Timothy; Winthrop, Kevin; Ringshausen, Felix C.; Previdi, Giuliana; Blasi, Francesco.

In: Multidisciplinary Respiratory Medicine, Vol. 13, No. Suppl. 1, 33, 09.08.2018.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The Italian registry of pulmonary non-tuberculous mycobacteria - IRENE

T2 - The study protocol

AU - IRENE Network

AU - Aliberti, Stefano

AU - Codecasa, Luigi Ruffo

AU - Gori, Andrea

AU - Sotgiu, Giovanni

AU - Spotti, Maura

AU - Di Biagio, Antonio

AU - Calcagno, Andrea

AU - Nardini, Stefano

AU - Assael, Baroukh Maurice

AU - Tortoli, Enrico

AU - Besozzi, Giorgio

AU - Ferrarese, Maurizio

AU - Matteelli, Alberto

AU - Girardi, Enrico

AU - De Lorenzo, Saverio

AU - Seia, Manuela

AU - Gramegna, Andrea

AU - Del Prato, Bruno

AU - Terranova, Leonardo

AU - Oriano, Martina

AU - Sverzellati, Nicola

AU - Mirsaeidi, Mehdi

AU - Chalmers, James D.

AU - Haworth, Charles S.

AU - Loebinger, Michael R.

AU - Aksamit, Timothy

AU - Winthrop, Kevin

AU - Ringshausen, Felix C.

AU - Previdi, Giuliana

AU - Blasi, Francesco

AU - Fusetti, Giuliana

AU - Martorana, Manuela

AU - Colella, Gennaro

AU - Verga, Giuseppina

AU - Carbone, Gerardina

AU - Damilano, Isabella

AU - Nava, Fabrizio

AU - Pancini, Lisa

AU - Pasat, Ana

AU - Vanoni, Nicolò

PY - 2018/8/9

Y1 - 2018/8/9

N2 - 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.

AB - 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.

KW - Atypical mycobacteria

KW - Bronchiectasis

KW - COPD

KW - Cystic fibrosis

KW - HIV

KW - Lung transplant

KW - M. Avium

KW - M. Intracellulare

KW - NTM, NTM-PD

U2 - 10.1186/s40248-018-0141-8

DO - 10.1186/s40248-018-0141-8

M3 - Article

VL - 13

JO - Multidisciplinary Respiratory Medicine

JF - Multidisciplinary Respiratory Medicine

SN - 1828-695X

IS - Suppl. 1

M1 - 33

ER -