TY - JOUR
T1 - The Italian registry of pulmonary non-tuberculous mycobacteria - IRENE
T2 - The study protocol
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
N1 - Funding Information:
The IRENE Executive Committee wants to acknowledge the support of Dr. Giuliana Fusetti, Dr. Manuela Martorana, Dr. Gennaro Colella, Avv. Giuseppina Verga; Dr. Gerardina Carbone, Dr. Isabella Damilano, Dr. Fabrizio Nava, Dr. Lisa Pancini, Dr. Ana Pasat and Dr. Nicolò Vanoni from the Policlinico Hospital in Milan, and of the Invisiblefarm company. The IRENE network also recognizes the support of the Fondazione IRCCS Ca′ Granda, Ospedale Maggiore Policlinico Milano, the University of Milan, the Italian Ministry of Health, the Italian Respiratory Society (Società Italiana di Pneumologia -SIP/IRS), the Italian Society of Cystic Fibrosis (SIFC), STOP-TB Italia and the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC).
Funding Information:
The sponsor of IRENE is Fondazione IRCCS Ca′ Granda, Ospedale Maggiore Policlinico, Milano, Italy, which received so far an unrestricted grant by Insmed Incorporated. Publication costs of this article will be funded by Novamedia and Italian Respiratory Society (IRS).
Publisher Copyright:
© 2018 The Author(s).
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
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U2 - 10.1186/s40248-018-0141-8
DO - 10.1186/s40248-018-0141-8
M3 - Article
AN - SCOPUS:85051276384
SN - 1828-695X
VL - 13
JO - Multidisciplinary Respiratory Medicine
JF - Multidisciplinary Respiratory Medicine
M1 - 33
ER -