Clinical trial NCT03339063: The Italian REgistry of Pulmonary Non-tuberculous mycobactEria
Official title: The Italian Registry of Pulmonary Non-tuberculous Mycobacteria
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nontuberculous Mycobacteria
Keywords: Nontuberculous Mycobacteria
Non-tuberculous mycobacteria
NTM-PD
NTM-LD
MAC
M. avium
M. intracellulare
M. abscessus
Atypical mycobacteria
NTM
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
Collaborators: name: Niguarda Hospital
name: Azienda Ospedaliera San Gerardo di Monza
name: ASST Fatebenefratelli Sacco
name: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
name: University of Turin, Italy
name: A.O.U. Città della Salute e della Scienza - Molinette Hospital
name: Azienda Unità Locale Socio Sanitaria n.9 Treviso
name: Ospedale Maggiore Di Trieste
name: Azienda Ospedaliero-Universitaria di Modena
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Università degli Studi di Ferrara
name: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
name: Azienda Ospedaliero, Universitaria Pisana
name: Azienda Ospedaliero-Universitaria Careggi
name: Ospedale San Jacopo, Pistoia, Italy
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Azienda Policlinico Umberto I
name: Istituto Nazionale per le Malattie Infettive Spallanzani, Roma
name: Policlinico Universitario, Catania
name: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
name: Azienda Ospedaliera Cosenza
name: Azienda Ospedaliero Universitaria di Sassari
First posted: 2017-11-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients included in the registry are mainly recruited among pulmonary and Infectious diseases out- and in-patient services. Adult cystic fibrosis, lung transplant, and tuberculosis clinics represent other recruitment centers. A heterogeneous population of patients with NTM infection/NTM-Pulmonary Disease sharing different clinical phenotypes is expected to be enrolled in the registry. IRENE has a special focus on four patients' categories: 1) immunocompetent/bronchiectatic, 2) HIV-positive, 3) cystic fibrosis and 4) lung transplanted patients.

Brief summary: The Italian registry of pulmonary non-tuberculous mycobacteria (NTM) -IRENE- is an observational, multicenter, prospective, cohort study enrolling consecutive adult patients with either a NTM respiratory infection or NTM-Pulmonary Disease. The coordinating center is located at the Pulmonary Department of the Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy. So far, more than 35 centers, including mainly pulmonary and infectious disease departments, joined the registry. The registry has been developed to accept an unlimited number of patients and no deadlines have been decided.

Detailed description: The epidemiology of patients suffering from a pulmonary disease due to NTM (NTM-PD), which is characterized by symptomatic, progressive inflammatory lung damage and defined in 2007 in the ATS/IDSA guidelines, still remains unclear. Reporting of NTM-PD to health authorities is often not mandated in several countries and the current estimates have been obtained from sentinel surveillance or laboratory-based studies, retrospective cohort studies, or audits of administrative databases. Until now no data have been published on the epidemiology of respiratory NTM infections in Italy.

The Italian registry of pulmonary NTM (IRENE) is an observational, multicenter, prospective, cohort study enrolling consecutive adult patients with either a NTM respiratory infection or NTM-PD. The coordinating center is located at the Pulmonary Department of the Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy. So far, more than 35 centers, including mainly pulmonary and infectious disease departments, joined the registry. The study is sponsored by the Policlinico Hospital in Milan. The study website is located at www.registroirene.it.

Adult (\>=18 years) 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 included in the registry are mainly recruited among pulmonary and ID out- and in-patient services. Adult cystic fibrosis, lung transplant, and tuberculosis clinics represent other recruitment centers. The registry has been developed to accept an unlimited number of patients and no deadlines have been decided.

Patients are managed according to standard operating procedures implemented in each IRENE clinical center without any interference from the study team. A baseline case report form is collected at patient's enrolment including demographics, comorbidities, microbiological, laboratory, functional, radiological, clinical, and treatment data. Then, study investigators enter follow-up data on an annual basis.

An IRENE biobank has also been developed within the network and linked to the clinical data of the registry. IRENE sites can collect samples, including blood, serum, plasma, respiratory specimens (sputum, induced sputum, tracheal aspirate, or bronchoalveolar lavage), urine, and NTM isolates at the first visit and during follow up on a voluntary basis.

Eligibility criteria: Inclusion Criteria (all of them):

* Adult (\>=18 years) patients
* At least one positive culture for any NTM species from any respiratory sample
* At least one positive culture for NTM isolated in the year prior the enrolment and/or prescribed NTM treatment in the year prior the enrollment
* Given consent to inclusion in the study.

Exclusion Criteria:

No exclusion criteria are applied to the study

Primary outcomes:
measure: Proportion of patients meeting the quality standards for NTM-PD care suggested by international guidelines (including the latest ERS 2017 guidelines)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Clinic of Infectious Diseases, 'San Gerardo" Hospital-ASST Monza, University Milano-Bicocca, Milano
state: Monza Brianza
city: Bologna
country: Italy
facility: Malattie Infettive, Alma Mater Studiorum Università di Bologna
city: Bologna
country: Italy
facility: Pneumologia, Alma Mater Studiorum Università di Bologna
city: Brescia
country: Italy
facility: Clinica di Malattie Infettive e Malattie Tropicali, Spedali Civili di Brescia, Università di Brescia
city: Catania
country: Italy
facility: Malattie Infettive, Ospedale Garibaldi-NESIMA di Catania
city: Cosenza
country: Italy
facility: U.O.C. Malattie Infettive, Azienda Ospedaliera di Cosenza
city: Ferrara
country: Italy
facility: Pneumologia, Azienda Ospedaliero-Universitaria di Ferrara
city: Firenze
country: Italy
facility: Dipartimento Medicina Sperimentale e Clinica, SOD Malattie Infettive e Tropicali, Azienda Ospedaliero Universitaria Careggi
city: Genova
country: Italy
facility: Malattie Infettive, IRCCS-AOU San Martino
city: Milan
country: Italy
facility: 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
city: Milan
country: Italy
facility: Malattie Infettive, Ospedale Luigi Sacco
city: Milan
country: Italy
facility: Pneumologia, Ospedale Luigi Sacco
city: Milan
country: Italy
facility: Regional TB Reference Centre, Istituto Villa Marelli, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy
city: Modena
country: Italy
facility: Malattie Infettive, Ospedale di Modena
city: Modena
country: Italy
facility: Pneumologia, Ospedale di Modena
city: Pavia
country: Italy
facility: Pneumologia, Fondazione IRCCS Policlinico San Matteo
city: Pisa
country: Italy
facility: Pneumologia, Ospedale di Pisa
city: Pistoia
country: Italy
facility: S.O.C. Malattie Infettive II, AUSL Toscana Centro - Pistoia, Ospedale San Jacopo
city: Roma
country: Italy
facility: Pneumologia, Policlinico Gemelli
city: Roma
country: Italy
facility: UOC di Medicina Interna e Disfunzioni Respiratorie, Azienda Universitaria Ospedaliera Policlinico Umberto I di Roma
city: Roma
country: Italy
facility: UOS Day Service Malattia Tubercolare afferente all'UOC Malattie Infettive dell'Apparato Respiratorio, Istituto Nazionale per le Malattie Infettive "L. Spallanzani" - IRCCS
city: Sassari
country: Italy
facility: Pneumologia, Dipartimento Di Medicina Clinica e Sperimentale, Università degli studi di Sassari
city: Torino
country: Italy
facility: Divisione di Pneumologia, AOU Città della Salute e della Scienza di Torino, Molinette
city: Torino
country: Italy
facility: Malattie Infettive, Università degli studi di Torino
city: Treviso
country: Italy
facility: UO di Pneumotisiologia, Ospedale di Vittorio Veneto
city: Trieste
country: Italy
facility: Dipartimento di Pneumologia, Ospedale Universitario di Cattinara
Study officials:
affiliation: 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, Milan, Italy
name: Stefano Aliberti, MD
role: STUDY_DIRECTOR
affiliation: 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, Milan, Italy
name: Francesco Blasi, MD
role: STUDY_CHAIR
affiliation: Regional TB Reference Centre, Istituto Villa Marelli, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy
name: Luigi Ruffo Codecasa, MD
role: STUDY_CHAIR
affiliation: Clinic of Infectious Diseases, 'San Gerardo" Hospital-ASST Monza, University Milano-Bicocca, Milano, Italy
name: Andrea Gori, MD
role: STUDY_CHAIR
References:
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citation: Faverio P, Stainer A, Bonaiti G, Zucchetti SC, Simonetta E, Lapadula G, Marruchella A, Gori A, Blasi F, Codecasa L, Pesci A, Chalmers JD, Loebinger MR, Aliberti S. Characterizing Non-Tuberculous Mycobacteria Infection in Bronchiectasis. Int J Mol Sci. 2016 Nov 16;17(11):1913. doi: 10.3390/ijms17111913.
citation: Bonaiti G, Pesci A, Marruchella A, Lapadula G, Gori A, Aliberti S. Nontuberculous Mycobacteria in Noncystic Fibrosis Bronchiectasis. Biomed Res Int. 2015;2015:197950. doi: 10.1155/2015/197950. Epub 2015 May 27.
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citation: Floto RA, Olivier KN, Saiman L, Daley CL, Herrmann JL, Nick JA, Noone PG, Bilton D, Corris P, Gibson RL, Hempstead SE, Koetz K, Sabadosa KA, Sermet-Gaudelus I, Smyth AR, van Ingen J, Wallace RJ, Winthrop KL, Marshall BC, Haworth CS; US Cystic Fibrosis Foundation and European Cystic Fibrosis Society. US Cystic Fibrosis Foundation and European Cystic Fibrosis Society consensus recommendations for the management of non-tuberculous mycobacteria in individuals with cystic fibrosis. Thorax. 2016 Jan;71 Suppl 1(Suppl 1):i1-22. doi: 10.1136/thoraxjnl-2015-207360.
citation: 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; IRENE Network. The Italian registry of pulmonary non-tuberculous mycobacteria - IRENE: the study protocol. Multidiscip Respir Med. 2018 Aug 9;13(Suppl 1):33. doi: 10.1186/s40248-018-0141-8. eCollection 2018.