The Italian registry of pulmonary nontuberculous mycobacteria - IRENE: the study protocol
The Italian registry of pulmonary nontuberculous mycobacteria - IRENE: the study protocol
Authors
Stefano Aliberti
Department of Pathophysiology and Transplantation, University of Milan; Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Adult Center, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico, Milano
Luigi Ruffo Codecasa
Regional TB Reference Centre, Istituto Villa Marelli, ASST Grande Ospedale Metropolitano Niguarda, Milano
Andrea Gori
Clinic of Infectious Diseases, "San Gerardo" Hospital-ASST Monza, University Milano-Bicocca, Milano
Giovanni Sotgiu
Clinical Epidemiology and Medical Statistics Unit, Department of Clinical and Experimental Medicine, University of Sassari, Sassari
Maura Spotti
Department of Pathophysiology and Transplantation, University of Milan; Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Adult Center, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico, Milano
Antonio Di Biagio
Clinica Malattie Infettive, Policlinico Ospedale S. Martino, Genoa
Andrea Calcagno
Unit of Infectious Diseases, Department of Medical Sciences, University of Torino, Torino
Stefano Nardini
Ospedale Civile, Pulmonary and TB Unit, Vittorio Veneto
Baroukh Maurice Assael
Department of Pathophysiology and Transplantation, University of Milan; Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Adult Center, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico, Milano
Enrico Tortoli
Emerging Bacterial Pathogens Unit, IRCCS San Raffaele Scientific Institute, Milan
Giorgio Besozzi
StopTB Italia, Milan
Maurizio Ferrarese
Regional TB Reference Centre, Istituto Villa Marelli, ASST Grande Ospedale Metropolitano Niguarda, Milano
Alberto Matteelli
WHO Collaborating Centre for TB/ HIV co-infection and TB Elimination, Department of Infectious and Tropical Diseases, University of Brescia, Brescia
Enrico Girardi
Clinical Epidemiology Unit, National Institute for Infectious Disease “L. Spallanzani, Rome
Saverio De Lorenzo
E. Morelli Hospital ASST, Reference Center for MDR-TB and HIV-TB, Sondalo
Manuela Seia
Medical Genetics Laboratory, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico, Milan
Andrea Gramegna
Department of Pathophysiology and Transplantation, University of Milan; Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Adult Center, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico, Milano
Bruno Del Prato
Unit of Interventional Pulmonology, High Speciality “A. Cardarelli” Hospital, Naples
Leonardo Terranova
ediatric Highly Intensive Care Unit, Department of Pathophysiology and Transplantation, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan
Martina Oriano
Department of Pathophysiology and Transplantation, University of Milan; Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Adult Center, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico, Milano
Nicola Sverzellati
Scienze Radiologiche, Dipartimento di Medicina e Chirurgia, Università di Parma, Parma
Mehdi Mirsaeidi
Miami Veterans Administration Medical Center, Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, University of Miami School of Medicine, Miami, FL
James D. Chalmers
Scottish Centre for Respiratory Research, University of Dundee, Ninewells Hospital and Medical School, Dundee
Charles S. Haworth
Cambridge Centre for Lung Infection, Papworth Hospital, Cambridge
Michael R. Loebinger
Host Defence Clinic, Royal Brompton Hospital, London
Timothy Aksamit
Mayo Clinic College of Medicine, Rochester, MN
Kevin Winthrop
Oregon Health and Science University, Portland, OR
Felix C. Ringshausen
Dept of Respiratory Medicine, Member of the German Centre for Lung Research, Hannover Medical School, Hannover
Giuliana Previdi
Aziende Socio Sanitarie Territoriale Melegnano e della Martesana, Vizzolo Predabissi, Milano
Francesco Blasi
Department of Pathophysiology and Transplantation, University of Milan; Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Adult Center, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico, Milano
NTM, NTM-PD, COPD, M. Avium, M. Intracellulare, Atypical mycobacteria, Bronchiectasis, Cystic fibrosis, Lung transplant, HIV
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.
Aliberti S, Ruffo Codecasa L, Gori A, et al. The Italian registry of pulmonary nontuberculous mycobacteria - IRENE: the study protocol. Multidiscip Respir Med. 2019;13. doi:10.4081/mrm.2018.101
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