The Italian registry of pulmonary non-tuberculous mycobacteria - IRENE: the study protocol

Abstract

BackgroundA substantial increase in pulmonary and extra-pulmonary diseases due to non-tuberculous mycobacteria (NTM) has been documented worldwide, especially among subjects suffering from chronic respiratory diseases and immunocompromised patients. Many questions remain regarding the epidemiology of pulmonary disease due to NTM (NTM-PD) mainly because reporting of NTM-PD to health authorities is not mandated in several countries, including Italy. This manuscript describes the protocol of the first Italian registry of adult patients with respiratory infections caused by NTM (IRENE).MethodsIRENE is an observational, multicenter, prospective, cohort study enrolling consecutive adult patients with either a NTM respiratory isolate or those with NTM-PD. A total of 41 centers, including mainly pulmonary and infectious disease departments, joined the registry so far. Adult 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 are managed according to standard operating procedures implemented in each IRENE clinical center. An online case report form has been developed to collect patients’ demographics, comorbidities, microbiological, laboratory, functional, radiological, clinical, treatment and outcome data at baseline and on an annual basis. An IRENE biobank has also been developed within the network and linked to the clinical data of the registry.ConclusionsIRENE has been developed to inform the clinical and scientific community on the current management of adult patients with NTM respiratory infections in Italy and acts as a national network to increase the disease’s awareness.Trial registrationClinicaltrial.gov: NCT03339063.

Protocol of a Nationwide Observational Study among Patients with Nontuberculous Mycobacterium Pulmonary Disease in South Korea (NTM-KOREA)

“…However, the attention surrounding this neglected disease has increased, and several registries have been launched globally. Registries for NTM-PD have been founded in Italy (ClinicalTrials.gov ID: NCT03339063) 14 and Singapore (NCT02355015). The noncystic fibrosis bronchiectasis registry, called the Bronchiectasis Research Registry, has recruited participants in the United States and reports that 63% of the population has a history of NTM-PD or NTM infection 15 .…”

18-fluorodeoxyglucose positron emission tomography (FDG-PET) in patients with non-tuberculous mycobacterial infections

“…We performed a secondary analysis of a prospective observational cohort study including adult (>= 18 years of age) patients with NTM-LD J o u r n a l P r e -p r o o f followed at the Amedeo di Savoia Hospital (Turin, Italy) who underwent FDG-PET/CT between 2015 and 2021. All patients were part of the prospective study from the Italian Register of pulmonary Nontuberculous mycobactEria (IRENE), that comprises more than 900 NTM patients [7]. Informed consent was obtained from all participants included in the study.…”

European Respiratory Society International Congress, Madrid, 2019: nontuberculous mycobacterial pulmonary disease highlights

“…Despite European efforts to increase awareness of NTM and to improve treatment in line with guideline recommendations, there is still some way to go. Even in 2020, a survey by NTM-NET [ 57 ] has shown that patients with bronchiectasis (those at highest risk of contracting NTM [ 58 , 59 ]) are not being routinely tested for NTM; this includes patients being considered for macrolide monotherapy, despite strong recommendations from 2020 guidelines that NTM testing should be conducted before treatment initiation [60]. Importantly, among surveyed clinicians there was relatively high (>60%) understanding of the mortality and morbidity burden of NTM.…”