The Italian REgistry of Pulmonary Non-tuberculous mycobactEria

ClinicalTrials.gov ID

NCT03339063

Lead Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

500Estimated

Last Update Posted

Mar 26, 2018Actual

Start Date

Apr 21, 2017Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

Official Title

The Italian Registry of Pulmonary Non-tuberculous Mycobacteria

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.

• Nontuberculous Mycobacteria

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoOTHER

Collaborators

Niguarda HospitalOTHER

Azienda Ospedaliera San Gerardo di MonzaOTHER

ASST Fatebenefratelli SaccoOTHER

Fondazione IRCCS Policlinico San Matteo di PaviaOTHER

Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaOTHER

University of Turin, ItalyOTHER

A.O.U. Città della Salute e della Scienza - Molinette HospitalOTHER

Azienda Unità Locale Socio Sanitaria n.9 TrevisoOTHER

Ospedale Maggiore Di TriesteOTHER

Azienda Ospedaliero-Universitaria di ModenaOTHER

IRCCS Azienda Ospedaliero-Universitaria di BolognaOTHER

Università degli Studi di FerraraOTHER

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyOTHER

Azienda Ospedaliero, Universitaria PisanaOTHER

Azienda Ospedaliero-Universitaria CareggiOTHER

Ospedale San Jacopo, Pistoia, ItalyUNKNOWN

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Azienda Policlinico Umberto IOTHER

Istituto Nazionale per le Malattie Infettive Spallanzani, RomaUNKNOWN

Policlinico Universitario, CataniaOTHER

Azienda Ospedaliera Universitaria Policlinico "G. Martino"OTHER

Azienda Ospedaliera CosenzaOTHER

Azienda Ospedaliero Universitaria di SassariOTHER

adibiagioa@gmail.com

fabio.franzetti@unimi.it

pierachille.santus@unimi.it

cristina.mussini@unimore.it

fabrizio.luppi@unimore.it

pierluigi.paggiaro@unipi.it

Luca.richeldi@policlinicogemelli.it

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