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The Italian REgistry of Pulmonary Non-tuberculous mycobactEria (IRENE)

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ClinicalTrials.gov Identifier: NCT03339063
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : March 26, 2018
Sponsor:
Collaborators:
Niguarda Hospital
Azienda Ospedaliera San Gerardo di Monza
ASST Fatebenefratelli Sacco
Policlinico San Matteo Pavia Fondazione IRCCS
Azienda Ospedaliera 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
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
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
Policlinico Universitario Agostino Gemelli
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
Information provided by (Responsible Party):
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.

Condition or disease
Nontuberculous Mycobacteria

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: The Italian Registry of Pulmonary Non-tuberculous Mycobacteria
Actual Study Start Date : April 21, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Proportion of patients meeting the quality standards for NTM-PD care suggested by international guidelines (including the latest ERS 2017 guidelines) [ Time Frame: 5 years ]
    The number of patients with NTM-PD who have been managed or treated according to the recommendations published by international guidelines


Biospecimen Retention:   Samples With DNA
Sputum Bronchoalveolar lavage Full Blood Serum Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339063


Contacts
Contact: Stefano Aliberti, MD +390250320627 stefano.aliberti@unimi.it

Locations
Italy
Clinic of Infectious Diseases, 'San Gerardo" Hospital-ASST Monza, University Milano-Bicocca, Milano Not yet recruiting
Monza, Monza Brianza, Italy
Contact: Andrea Gori, MD       andrea.gori@unimib.it   
Malattie Infettive, Alma Mater Studiorum Università di Bologna Not yet recruiting
Bologna, Italy
Contact: Pierluigi Viale, MD       pierluigi.viale@unibo.it   
Pneumologia, Alma Mater Studiorum Università di Bologna Not yet recruiting
Bologna, Italy
Contact: Stefano Nava, MD       stefano.nava@aosp.bo.it   
Clinica di Malattie Infettive e Malattie Tropicali, Spedali Civili di Brescia, Università di Brescia Not yet recruiting
Brescia, Italy
Contact: Alberto Matteelli, MD       matteelli@med.unibs.it   
Malattie Infettive, Ospedale Garibaldi-NESIMA di Catania Not yet recruiting
Catania, Italy
Contact: Salvatore Tosto, MD       salvotosto56@yahoo.it   
U.O.C. Malattie Infettive, Azienda Ospedaliera di Cosenza Not yet recruiting
Cosenza, Italy
Contact: Antonio Mastroianni, MD       antoniomastroianni@yahoo.it   
Pneumologia, Azienda Ospedaliero-Universitaria di Ferrara Not yet recruiting
Ferrara, Italy
Contact: Marco Contoli, MD       marco.contoli@unife.it   
Dipartimento Medicina Sperimentale e Clinica, SOD Malattie Infettive e Tropicali, Azienda Ospedaliero Universitaria Careggi Not yet recruiting
Firenze, Italy
Contact: Filippo Bartalesi, MD       bartalesif@aou-careggi.toscana.it   
Malattie Infettive, IRCCS-AOU San Martino Not yet recruiting
Genova, Italy
Contact: Antonio Di Biagio, MD       adibiagioa@gmail.com   
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 Recruiting
Milan, Italy, 20122
Contact: Stefano Aliberti, MD    +390250320627    stefano.aliberti@unimi.it   
Malattie Infettive, Ospedale Luigi Sacco Not yet recruiting
Milan, Italy
Contact: Fabio Franzetti, MD       fabio.franzetti@unimi.it   
Pneumologia, Ospedale Luigi Sacco Not yet recruiting
Milan, Italy
Contact: Pierachille Santus, PhD       pierachille.santus@unimi.it   
Regional TB Reference Centre, Istituto Villa Marelli, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy Not yet recruiting
Milan, Italy
Contact: Luigi Ruffo Codecasa, MD    +390264445833    luigiruffo.codecasa@ospedaleniguarda.it   
Malattie Infettive, Ospedale di Modena Not yet recruiting
Modena, Italy
Contact: Cristina Mussini, MD       cristina.mussini@unimore.it   
Pneumologia, Ospedale di Modena Not yet recruiting
Modena, Italy
Contact: Fabrizio Luppi, MD       fabrizio.luppi@unimore.it   
Pneumologia, Fondazione IRCCS Policlinico San Matteo Not yet recruiting
Pavia, Italy
Contact: Angelo Corsico, MD       corsico@unipv.it   
Pneumologia, Ospedale di Pisa Not yet recruiting
Pisa, Italy
Contact: Pierluigi Paggiaro, MD       pierluigi.paggiaro@unipi.it   
S.O.C. Malattie Infettive II, AUSL Toscana Centro - Pistoia, Ospedale San Jacopo Not yet recruiting
Pistoia, Italy
Contact: Michele Trezzi, MD       michele.trezzi@gmail.com   
Pneumologia, Policlinico Gemelli Not yet recruiting
Roma, Italy
Contact: Luca Richeldi, MD       Luca.richeldi@policlinicogemelli.it   
UOC di Medicina Interna e Disfunzioni Respiratorie, Azienda Universitaria Ospedaliera Policlinico Umberto I di Roma Not yet recruiting
Roma, Italy
Contact: Paolo Palange, MD       paolo.palange@uniroma1.it   
UOS Day Service Malattia Tubercolare afferente all'UOC Malattie Infettive dell'Apparato Respiratorio, Istituto Nazionale per le Malattie Infettive "L. Spallanzani" - IRCCS Not yet recruiting
Roma, Italy
Contact: Gina Gualano, MD       gina.gualano@inmi.it   
Pneumologia, Dipartimento Di Medicina Clinica e Sperimentale, Università degli studi di Sassari Not yet recruiting
Sassari, Italy
Contact: Pietro Pirina, MD       pirina@uniss.it   
Divisione di Pneumologia, AOU Città della Salute e della Scienza di Torino, Molinette Not yet recruiting
Torino, Italy
Contact: Paolo Solidoro, MD       psolidoro@cittadellasalute.to.it   
Malattie Infettive, Università degli studi di Torino Not yet recruiting
Torino, Italy
Contact: Andrea Calcagno, MD       andrea.calcagno@unito.it   
UO di Pneumotisiologia, Ospedale di Vittorio Veneto Not yet recruiting
Treviso, Italy
Contact: Stefano Nardini, MD       snardini.pneumologo@gmail.com   
Dipartimento di Pneumologia, Ospedale Universitario di Cattinara Not yet recruiting
Trieste, Italy
Contact: Marco Confalonieri, MD       marco.confalonieri@aots.sanita.fvg.it   
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Niguarda Hospital
Azienda Ospedaliera San Gerardo di Monza
ASST Fatebenefratelli Sacco
Policlinico San Matteo Pavia Fondazione IRCCS
Azienda Ospedaliera 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
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
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
Policlinico Universitario Agostino Gemelli
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
Investigators
Study Director: Stefano Aliberti, MD 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
Study Chair: Francesco Blasi, MD 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
Study Chair: Luigi Ruffo Codecasa, MD Regional TB Reference Centre, Istituto Villa Marelli, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy
Study Chair: Andrea Gori, MD Clinic of Infectious Diseases, 'San Gerardo" Hospital-ASST Monza, University Milano-Bicocca, Milano, Italy
  Study Documents (Full-Text)

Documents provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Study Protocol  [PDF] June 21, 2017
Statistical Analysis Plan  [PDF] June 21, 2017


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT03339063     History of Changes
Other Study ID Numbers: IRENE
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IRENE is the official Italian network within the EMBARC European NTM registry. All Italian patients included in the European NTM registry will be enrolled through IRENE and IRENE data will be incorporated into the European NTM registry.
Supporting Materials: Study Protocol
Time Frame: 2018-2023
Access Criteria: All the patients' data

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Nontuberculous Mycobacteria
Non-tuberculous mycobacteria
NTM-PD
NTM-LD
MAC
M. avium
M. intracellulare
M. abscessus
Atypical mycobacteria
NTM

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections