Nontuberculous MycobacteriaIRENENCT03339063
The Italian REgistry of Pulmonary Non-tuberculous mycobactEria
An observational study of Nontuberculous Mycobacteria, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 26 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nontuberculous Mycobacteria
- How many people
- 500 participants
- Where
- 26 sitesItaly
- Study dates
- 21 Apr 2017to 31 Dec 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- No exclusion criteria are applied to the study
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Italy26 sites, 26 recruiting
- Not yet recruiting
Malattie Infettive, Alma Mater Studiorum Università di Bologna
Bologna
Pierluigi Viale, MD, pierluigi.viale@unibo.it
- Not yet recruiting
Pneumologia, Alma Mater Studiorum Università di Bologna
Bologna
Stefano Nava, MD, stefano.nava@aosp.bo.it
- Not yet recruiting
Clinica di Malattie Infettive e Malattie Tropicali, Spedali Civili di Brescia, Università di Brescia
Brescia
Alberto Matteelli, MD, matteelli@med.unibs.it
- Not yet recruiting
Malattie Infettive, Ospedale Garibaldi-NESIMA di Catania
Catania
Salvatore Tosto, MD, salvotosto56@yahoo.it
- Not yet recruiting
U.O.C. Malattie Infettive, Azienda Ospedaliera di Cosenza
Cosenza
Antonio Mastroianni, MD, antoniomastroianni@yahoo.it
- Not yet recruiting
Pneumologia, Azienda Ospedaliero-Universitaria di Ferrara
Ferrara
Marco Contoli, MD, marco.contoli@unife.it
- Not yet recruiting
Dipartimento Medicina Sperimentale e Clinica, SOD Malattie Infettive e Tropicali, Azienda Ospedaliero Universitaria Careggi
Florence
Filippo Bartalesi, MD, bartalesif@aou-careggi.toscana.it
- Not yet recruiting
Malattie Infettive, IRCCS-AOU San Martino
Genova
Antonio Di Biagio, MD, adibiagioa@gmail.com
- Recruiting
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
Stefano Aliberti, MD, +390250320627, stefano.aliberti@unimi.it
- Not yet recruiting
Malattie Infettive, Ospedale Luigi Sacco
Milan
Fabio Franzetti, MD, fabio.franzetti@unimi.it
- Not yet recruiting
Pneumologia, Ospedale Luigi Sacco
Milan
Pierachille Santus, PhD, pierachille.santus@unimi.it
- Not yet recruiting
Regional TB Reference Centre, Istituto Villa Marelli, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy
Milan
Luigi Ruffo Codecasa, MD, +390264445833, luigiruffo.codecasa@ospedaleniguarda.it
- Not yet recruiting
Malattie Infettive, Ospedale di Modena
Modena
Cristina Mussini, MD, cristina.mussini@unimore.it
- Not yet recruiting
Pneumologia, Ospedale di Modena
Modena
Fabrizio Luppi, MD, fabrizio.luppi@unimore.it
- Not yet recruiting
Clinic of Infectious Diseases, 'San Gerardo" Hospital-ASST Monza, University Milano-Bicocca, Milano
Monza, Monza Brianza
Andrea Gori, MD, andrea.gori@unimib.it
- Not yet recruiting
Pneumologia, Fondazione IRCCS Policlinico San Matteo
Pavia
Angelo Corsico, MD, corsico@unipv.it
- Not yet recruiting
Pneumologia, Ospedale di Pisa
Pisa
Pierluigi Paggiaro, MD, pierluigi.paggiaro@unipi.it
- Not yet recruiting
S.O.C. Malattie Infettive II, AUSL Toscana Centro - Pistoia, Ospedale San Jacopo
Pistoia
Michele Trezzi, MD, michele.trezzi@gmail.com
- Not yet recruiting
Pneumologia, Policlinico Gemelli
Roma
Luca Richeldi, MD, Luca.richeldi@policlinicogemelli.it
- Not yet recruiting
UOC di Medicina Interna e Disfunzioni Respiratorie, Azienda Universitaria Ospedaliera Policlinico Umberto I di Roma
Roma
Paolo Palange, MD, paolo.palange@uniroma1.it
- Not yet recruiting
UOS Day Service Malattia Tubercolare afferente all'UOC Malattie Infettive dell'Apparato Respiratorio, Istituto Nazionale per le Malattie Infettive "L. Spallanzani" - IRCCS
Roma
Gina Gualano, MD, gina.gualano@inmi.it
- Not yet recruiting
Pneumologia, Dipartimento Di Medicina Clinica e Sperimentale, Università degli studi di Sassari
Sassari
Pietro Pirina, MD, pirina@uniss.it
- Not yet recruiting
Divisione di Pneumologia, AOU Città della Salute e della Scienza di Torino, Molinette
Torino
Paolo Solidoro, MD, psolidoro@cittadellasalute.to.it
- Not yet recruiting
Malattie Infettive, Università degli studi di Torino
Torino
Andrea Calcagno, MD, andrea.calcagno@unito.it
- Not yet recruiting
UO di Pneumotisiologia, Ospedale di Vittorio Veneto
Treviso
Stefano Nardini, MD, snardini.pneumologo@gmail.com
- Not yet recruiting
Dipartimento di Pneumologia, Ospedale Universitario di Cattinara
Trieste
Marco Confalonieri, MD, marco.confalonieri@aots.sanita.fvg.it
About this study
Official title: The Italian Registry of Pulmonary Non-tuberculous Mycobacteria
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.
Read the 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.
- Conditions
- Nontuberculous Mycobacteria
- Keywords
- Nontuberculous Mycobacteria, Non-tuberculous mycobacteria, NTM-PD, NTM-LD, MAC, M. avium, M. intracellulare, M. abscessus, Atypical mycobacteria, NTM
- Medical subject headings
- Mycobacterium Infections, Nontuberculous
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start21 Apr 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nontuberculous MycobacteriaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Niguarda Hospital, Azienda Ospedaliera San Gerardo di Monza, ASST Fatebenefratelli Sacco, Fondazione IRCCS Policlinico San Matteo di Pavia, Azienda Socio Sanitaria Territoriale degli 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, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 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, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 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
- Responsible party
- Sponsor
- Investigators
- Stefano Aliberti, MD, Study director, 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, ItalyFrancesco Blasi, MD, Study chair, 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, ItalyLuigi Ruffo Codecasa, MD, Study chair, Regional TB Reference Centre, Istituto Villa Marelli, ASST Grande Ospedale Metropolitano Niguarda, Milan, ItalyAndrea Gori, MD, Study chair, Clinic of Infectious Diseases, 'San Gerardo" Hospital-ASST Monza, University Milano-Bicocca, Milano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339063
- Sponsor's protocol ID
- IRENE
- Acronym
- IRENE
- Status last verified
- Nov 2017
- First submitted
- 22 Oct 2017
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 29054853Faverio 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.
PubMed 27854334Bonaiti 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.
PubMed 26106603Griffith 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.
PubMed 17277290Floto 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.
PubMed 26666259Aliberti 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.
PubMed 30151192
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Italian Registry of Pulmonary Non-tuberculous Mycobacteria
- ClinicalTrials.gov ID
- NCT03339063
- Acronym / sponsor ID
- IRENE / IRENE
- Conditions
- Nontuberculous Mycobacteria
- Keywords
- Nontuberculous Mycobacteria, Non-tuberculous mycobacteria, NTM-PD, NTM-LD, MAC, M. avium, M. intracellulare, M. abscessus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- Niguarda Hospital, Azienda Ospedaliera San Gerardo di Monza, ASST Fatebenefratelli Sacco, Fondazione IRCCS Policlinico San Matteo di Pavia, Azienda Socio Sanitaria Territoriale degli 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, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 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, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 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
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- No exclusion criteria are applied to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Background: PubMed 29054853Haworth 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.
- Background: PubMed 27854334Faverio 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.
- Background: PubMed 26106603Bonaiti 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.
- Background: PubMed 17277290Griffith 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.
- Background: PubMed 26666259Floto 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.
- Derived from this study: PubMed 30151192Aliberti 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Nontuberculous Mycobacteria
RecruitingObservational study
Study of Mycobacterial Infections
Mycobacterium Infections
Not yet recruitingPhase 2
Telacebec in Adults With Multibacillary Leprosy (TEBULA Leprosy Trial)
Leprosy, Multibacillary
Enrolling by invitationObservational study
Prospective Healthcare-Associated Links in Transmission of Nontuberculous Mycobacteria
Cystic Fibrosis, Nontuberculous Mycobacterial Pulmonary Infection
Active, not recruitingObservational study
Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma
Nontuberculous Mycobacteria, Mycobacterium Tuberculosis
RecruitingPhase 2
A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Aliberti, MD study director
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 study chair
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 study chair
Regional TB Reference Centre, Istituto Villa Marelli, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nontuberculous Mycobacteria, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 26 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefano Aliberti, MD (+390250320627, stefano.aliberti@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03339063, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2018.