The Italian REgistry of Pulmonary Non-tuberculous mycobactEria (IRENE)
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| ClinicalTrials.gov Identifier: NCT03339063 |
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Recruitment Status :
Recruiting
First Posted : November 13, 2017
Last Update Posted : March 26, 2018
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| Condition or disease |
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| Nontuberculous Mycobacteria |
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 Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 5 Years |
| Official Title: | The Italian Registry of Pulmonary Non-tuberculous Mycobacteria |
| Actual Study Start Date : | April 21, 2017 |
| Estimated Primary Completion Date : | December 31, 2022 |
| Estimated Study Completion Date : | December 31, 2022 |
- 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
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339063
| Contact: Stefano Aliberti, MD | +390250320627 | stefano.aliberti@unimi.it |
Show 26 study locations
| Study Director: | 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 | |
| Study Chair: | 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 | |
| Study Chair: | Luigi Ruffo Codecasa, MD | Regional TB Reference Centre, Istituto Villa Marelli, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy | |
| Study Chair: | Andrea Gori, MD | Clinic of Infectious Diseases, 'San Gerardo" Hospital-ASST Monza, University Milano-Bicocca, Milano, Italy |
Documents provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| ClinicalTrials.gov Identifier: | NCT03339063 |
| Other Study ID Numbers: |
IRENE |
| First Posted: | November 13, 2017 Key Record Dates |
| Last Update Posted: | March 26, 2018 |
| Last Verified: | November 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Supporting Materials: |
Study Protocol |
| Time Frame: | 2018-2023 |
| Access Criteria: | All the patients' data |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Nontuberculous Mycobacteria Non-tuberculous mycobacteria NTM-PD NTM-LD MAC |
M. avium M. intracellulare M. abscessus Atypical mycobacteria NTM |
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Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |