The Italian REgistry of Pulmonary Non-tuberculous mycobactEria

• Conditions: Nontuberculous Mycobacteria

• Registration Number: NCT03339063
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2017-04-21
• Study First Submitted: 2017-10-22
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-13
• Last Update Submitted: 2018-03-22
• Last Update Posted: 2018-03-26
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

No exclusion criteria are applied to the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients meeting the quality standards for NTM-PD care suggested by international guidelines (including the latest ERS 2017 guidelines)	5 years	The number of patients with NTM-PD who have been managed or treated according to the recommendations published by international guidelines

Trial Locations

Locations (26)

Malattie Infettive, Alma Mater Studiorum Università di Bologna; 🇮🇹 Bologna, Italy

Pneumologia, Ospedale di Modena; 🇮🇹 Modena, Italy

Pneumologia, Policlinico Gemelli; 🇮🇹 Roma, Italy

UOC di Medicina Interna e Disfunzioni Respiratorie, Azienda Universitaria Ospedaliera Policlinico Umberto I di Roma; 🇮🇹 Roma, Italy

Clinic of Infectious Diseases, 'San Gerardo" Hospital-ASST Monza, University Milano-Bicocca, Milano; 🇮🇹 Monza, Monza Brianza, Italy

Dipartimento Medicina Sperimentale e Clinica, SOD Malattie Infettive e Tropicali, Azienda Ospedaliero Universitaria Careggi; 🇮🇹 Firenze, Italy

Pneumologia, Alma Mater Studiorum Università di Bologna; 🇮🇹 Bologna, Italy

Clinica di Malattie Infettive e Malattie Tropicali, Spedali Civili di Brescia, Università di Brescia; 🇮🇹 Brescia, Italy

Pneumologia, Azienda Ospedaliero-Universitaria di Ferrara; 🇮🇹 Ferrara, Italy

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

Malattie Infettive, Ospedale Luigi Sacco; 🇮🇹 Milan, Italy

Pneumologia, Ospedale Luigi Sacco; 🇮🇹 Milan, Italy

S.O.C. Malattie Infettive II, AUSL Toscana Centro - Pistoia, Ospedale San Jacopo; 🇮🇹 Pistoia, Italy

UO di Pneumotisiologia, Ospedale di Vittorio Veneto; 🇮🇹 Treviso, Italy

UOS Day Service Malattia Tubercolare afferente all'UOC Malattie Infettive dell'Apparato Respiratorio, Istituto Nazionale per le Malattie Infettive "L. Spallanzani" - IRCCS; 🇮🇹 Roma, Italy

U.O.C. Malattie Infettive, Azienda Ospedaliera di Cosenza; 🇮🇹 Cosenza, Italy

Malattie Infettive, IRCCS-AOU San Martino; 🇮🇹 Genova, Italy

Malattie Infettive, Ospedale di Modena; 🇮🇹 Modena, Italy

Pneumologia, Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

Malattie Infettive, Ospedale Garibaldi-NESIMA di Catania; 🇮🇹 Catania, Italy

Regional TB Reference Centre, Istituto Villa Marelli, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy; 🇮🇹 Milan, Italy

Pneumologia, Ospedale di Pisa; 🇮🇹 Pisa, Italy

Divisione di Pneumologia, AOU Città della Salute e della Scienza di Torino, Molinette; 🇮🇹 Torino, Italy

Dipartimento di Pneumologia, Ospedale Universitario di Cattinara; 🇮🇹 Trieste, Italy

Pneumologia, Dipartimento Di Medicina Clinica e Sperimentale, Università degli studi di Sassari; 🇮🇹 Sassari, Italy

Malattie Infettive, Università degli studi di Torino; 🇮🇹 Torino, Italy