The Italian REgistry of Pulmonary Non-tuberculous mycobactEria

Nontuberculous Mycobacteria Clinical Trial

— IRENE  

Official title:

The Italian Registry of Pulmonary Non-tuberculous Mycobacteria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03339063
• Other study ID #: IRENE
• Status: Recruiting
• First received: October 22, 2017
• Last updated: March 22, 2018
• Start date: April 21, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2017
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Stefano Aliberti, MD
• Phone: +390250320627
• Email: stefano.aliberti[@]unimi.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mycobacterium Infections
• Nontuberculous Mycobacteria

Locations

Country	Name	City	State
Italy	Malattie Infettive, Alma Mater Studiorum Università di Bologna	Bologna
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	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	Firenze
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
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	Clinic of Infectious Diseases, 'San Gerardo" Hospital-ASST Monza, University Milano-Bicocca, Milano	Monza	Monza Brianza
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

Sponsors (24)

Lead Sponsor

Collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. Review. — View Citation

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). pii: E1913. — View Citation

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:i1-22. doi: 10.1136/thoraxjnl-2015-207360. — View Citation

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. Review. Erratum in: Am J Respir Crit Care Med. 2007 Apr 1;175(7):744-5. Dosage error in article text. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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