The Italian REgistry of Pulmonary Non-tuberculous mycobactEria

The Italian Registry of Pulmonary Non-tuberculous Mycobacteria

Sponsors

Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborator: Niguarda Hospital
Azienda Ospedaliera San Gerardo di Monza
ASST Fatebenefratelli Sacco
Policlinico San Matteo Pavia Fondazione IRCCS
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
University of Turin, Italy
A.O.U. Città della Salute e della Scienza - Molinette Hospital
Azienda Unità Locale Socio Sanitaria n.9 Treviso
Ospedale Maggiore Di Trieste
Azienda Ospedaliero-Universitaria di Modena
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Università degli Studi di Ferrara
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Azienda Ospedaliero, Universitaria Pisana
Azienda Ospedaliero-Universitaria Careggi
Ospedale San Jacopo, Pistoia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Azienda Policlinico Umberto I
Istituto Nazionale per le Malattie Infettive Spallanzani, Roma
Policlinico Universitario, Catania
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Azienda Ospedaliera Cosenza
Azienda Ospedaliero Universitaria di Sassari

Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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.

Overall Status Recruiting
Start Date 2017-04-21
Completion Date 2022-12-31
Primary Completion Date 2022-12-31
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Proportion of patients meeting the quality standards for NTM-PD care suggested by international guidelines (including the latest ERS 2017 guidelines) 5 years
Enrollment 500
Condition
Eligibility

Sampling Method:

Non-Probability Sample

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Stefano Aliberti, MD

Phone: +390250320627

Email: [email protected]

Location
Facility: Status: Contact:
Clinic of Infectious Diseases, 'San Gerardo" Hospital-ASST Monza, University Milano-Bicocca, Milano | Monza, Monza Brianza, Italy Not yet recruiting Andrea Gori, MD [email protected]
Malattie Infettive, Alma Mater Studiorum Università di Bologna | Bologna, Italy Not yet recruiting Pierluigi Viale, MD [email protected]
Pneumologia, Alma Mater Studiorum Università di Bologna | Bologna, Italy Not yet recruiting Stefano Nava, MD [email protected]
Clinica di Malattie Infettive e Malattie Tropicali, Spedali Civili di Brescia, Università di Brescia | Brescia, Italy Not yet recruiting Alberto Matteelli, MD [email protected]
Malattie Infettive, Ospedale Garibaldi-NESIMA di Catania | Catania, Italy Not yet recruiting Salvatore Tosto, MD [email protected]
U.O.C. Malattie Infettive, Azienda Ospedaliera di Cosenza | Cosenza, Italy Not yet recruiting Antonio Mastroianni, MD [email protected]
Pneumologia, Azienda Ospedaliero-Universitaria di Ferrara | Ferrara, Italy Not yet recruiting Marco Contoli, MD [email protected]
Dipartimento Medicina Sperimentale e Clinica, SOD Malattie Infettive e Tropicali, Azienda Ospedaliero Universitaria Careggi | Firenze, Italy Not yet recruiting Filippo Bartalesi, MD [email protected]
Malattie Infettive, IRCCS-AOU San Martino | Genova, Italy Not yet recruiting Antonio Di Biagio, MD [email protected]
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, 20122, Italy Recruiting Stefano Aliberti, MD +390250320627 [email protected]
Malattie Infettive, Ospedale Luigi Sacco | Milan, Italy Not yet recruiting Fabio Franzetti, MD [email protected]
Pneumologia, Ospedale Luigi Sacco | Milan, Italy Not yet recruiting Pierachille Santus, PhD [email protected]
Regional TB Reference Centre, Istituto Villa Marelli, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy | Milan, Italy Not yet recruiting Luigi Ruffo Codecasa, MD +390264445833 [email protected]
Malattie Infettive, Ospedale di Modena | Modena, Italy Not yet recruiting Cristina Mussini, MD [email protected]
Pneumologia, Ospedale di Modena | Modena, Italy Not yet recruiting Fabrizio Luppi, MD [email protected]
Pneumologia, Fondazione IRCCS Policlinico San Matteo | Pavia, Italy Not yet recruiting Angelo Corsico, MD [email protected]
Pneumologia, Ospedale di Pisa | Pisa, Italy Not yet recruiting Pierluigi Paggiaro, MD [email protected]
S.O.C. Malattie Infettive II, AUSL Toscana Centro - Pistoia, Ospedale San Jacopo | Pistoia, Italy Not yet recruiting Michele Trezzi, MD [email protected]
Pneumologia, Policlinico Gemelli | Roma, Italy Not yet recruiting Luca Richeldi, MD [email protected]
UOC di Medicina Interna e Disfunzioni Respiratorie, Azienda Universitaria Ospedaliera Policlinico Umberto I di Roma | Roma, Italy Not yet recruiting Paolo Palange, MD [email protected]
UOS Day Service Malattia Tubercolare afferente all'UOC Malattie Infettive dell'Apparato Respiratorio, Istituto Nazionale per le Malattie Infettive "L. Spallanzani" - IRCCS | Roma, Italy Not yet recruiting Gina Gualano, MD [email protected]
Pneumologia, Dipartimento Di Medicina Clinica e Sperimentale, Università degli studi di Sassari | Sassari, Italy Not yet recruiting Pietro Pirina, MD [email protected]
Divisione di Pneumologia, AOU Città della Salute e della Scienza di Torino, Molinette | Torino, Italy Not yet recruiting Paolo Solidoro, MD [email protected]
Malattie Infettive, Università degli studi di Torino | Torino, Italy Not yet recruiting Andrea Calcagno, MD [email protected]
UO di Pneumotisiologia, Ospedale di Vittorio Veneto | Treviso, Italy Not yet recruiting Stefano Nardini, MD [email protected]
Dipartimento di Pneumologia, Ospedale Universitario di Cattinara | Trieste, Italy Not yet recruiting Marco Confalonieri, MD [email protected]
Location Countries

Italy

Verification Date

2017-11-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym IRENE
Patient Data Yes
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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