NCT03339063|Unknown
The Italian REgistry of Pulmonary Non-tuberculous mycobactEria
IRENE
The Italian Registry of Pulmonary Non-tuberculous Mycobacteria
Loading search results
IRENE
The Italian Registry of Pulmonary Non-tuberculous Mycobacteria
Sponsor study identifier
observational
500
1 country
26
Study Start
April 21, 2017
Actual (reported)Primary Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 21, 2017
Actual (reported)October 22, 2017
Actual (reported)November 13, 2017
Actual (reported)December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Proportion of patients meeting the quality standards for NTM-PD care suggested by international guidelines (including the latest ERS 2017 guidelines)
The number of patients with NTM-PD who have been managed or treated according to the recommendations published by international guidelines
5 years
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.
Clinic of Infectious Diseases, 'San Gerardo" Hospital-ASST Monza, University Milano-Bicocca, Milano
Monza, Monza Brianza, Italy
Malattie Infettive, Alma Mater Studiorum Università di Bologna
Bologna, Italy
Haworth CS, Banks J, Capstick T, Fisher AJ, Gorsuch T, Laurenson IF, Leitch A, Loebinger MR, Milburn HJ, Nightingale M, Ormerod P, Shingadia D, Smith D, Whitehead N, Wilson R, Floto RA. British Thoracic Society guidelines for the management of non-tuberculous mycobacterial pulmonary disease (NTM-PD). Thorax. 2017 Nov;72(Suppl 2):ii1-ii64. doi: 10.1136/thoraxjnl-2017-210927. No abstract available.
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.
Sputum Bronchoalveolar lavage Full Blood Serum Urine
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
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
Luigi Ruffo Codecasa, MD
Regional TB Reference Centre, Istituto Villa Marelli, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy
First Submitted
October 22, 2017
First Posted
November 13, 2017
Study Start
April 21, 2017
Actual (reported)Primary Completion
December 31, 2022
Estimated (date passed)Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)
Contact the study team to confirm eligibility.
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
Malattie Infettive, Ospedale Garibaldi-NESIMA di Catania
Catania, Italy
U.O.C. Malattie Infettive, Azienda Ospedaliera di Cosenza
Cosenza, Italy
Pneumologia, Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, Italy
Dipartimento Medicina Sperimentale e Clinica, SOD Malattie Infettive e Tropicali, Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Malattie Infettive, IRCCS-AOU San Martino
Genova, 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, 20122, Italy
Malattie Infettive, Ospedale Luigi Sacco
Milan, Italy
Pneumologia, Ospedale Luigi Sacco
Milan, Italy
Regional TB Reference Centre, Istituto Villa Marelli, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy
Milan, Italy
Malattie Infettive, Ospedale di Modena
Modena, Italy
Pneumologia, Ospedale di Modena
Modena, Italy
Pneumologia, Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Pneumologia, Ospedale di Pisa
Pisa, Italy
S.O.C. Malattie Infettive II, AUSL Toscana Centro - Pistoia, Ospedale San Jacopo
Pistoia, Italy
Pneumologia, Policlinico Gemelli
Roma, Italy
UOC di Medicina Interna e Disfunzioni Respiratorie, Azienda Universitaria Ospedaliera Policlinico Umberto I di Roma
Roma, 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
Pneumologia, Dipartimento Di Medicina Clinica e Sperimentale, Università degli studi di Sassari
Sassari, Italy
Divisione di Pneumologia, AOU Città della Salute e della Scienza di Torino, Molinette
Torino, Italy
Malattie Infettive, Università degli studi di Torino
Torino, Italy
UO di Pneumotisiologia, Ospedale di Vittorio Veneto
Treviso, Italy
Dipartimento di Pneumologia, Ospedale Universitario di Cattinara
Trieste, Italy
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.
Griffith DE, Aksamit T, Brown-Elliott BA, Catanzaro A, Daley C, Gordin F, Holland SM, Horsburgh R, Huitt G, Iademarco MF, Iseman M, Olivier K, Ruoss S, von Reyn CF, Wallace RJ Jr, Winthrop K; ATS Mycobacterial Diseases Subcommittee; American Thoracic Society; Infectious Disease Society of America. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007 Feb 15;175(4):367-416. doi: 10.1164/rccm.200604-571ST. No abstract available.
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.
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.
Andrea Gori, MD
Clinic of Infectious Diseases, 'San Gerardo" Hospital-ASST Monza, University Milano-Bicocca, Milano, Italy
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 26, 2018
Record last verified: 2017-11
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: