Nontuberculous Mycobacteria Clinical Trial
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.
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.
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