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Observational Study
. 2025 Nov 17;15(1):40133.
doi: 10.1038/s41598-025-23847-6.

Clinical outcomes and adverse events of nontuberculous mycobacterial lung disease treated at an Italian tertiary referral center

Serena Maria Carli  1 , Paola Mencarini  2 , Maria Angela Vittoria Licata  1 , Maria Musso  1 , Carlotta Cerva  1 , Annelisa Mastrobattista  1 , Pietro Vittozzi  1 , Silvia Mosti  1 , Carla Nisii  3 , Antonio Mazzarelli  3 , Assunta Navarra  4 , Gabriella De Carli  4 , Stefania Ianniello  5 , Fabrizio Palmieri  1 , Gina Gualano  1
Affiliations
Observational Study

Clinical outcomes and adverse events of nontuberculous mycobacterial lung disease treated at an Italian tertiary referral center

Serena Maria Carli et al. Sci Rep. .

Abstract

Treatment of NTM lung disease (NTM-LD) is based on combinations of antimycobacterial drugs. It lasts 12 months if respiratory samples become culture negative, while in refractory cases it can last up to 18-24 months. Therapeutic pathway is complicated by frequent adverse events (AEs). Sometimes, symptomatic therapy is not sufficient to control AEs, making necessary to suspend the drug involved or the entire treatment. This study aims to describe the frequency and type of AEs in patients with NTM-LD and to evaluate their impact on the outcomes of treatment. This is a retrospective observational study. We analysed clinical data, regimen composition, AEs and outcomes of NTM-LD patients followed between January 2016 and June 2023 at the National Institute for Infectious Diseases "L. Spallanzani" in Rome. Out of 131 patients, fifty-eight (44.3%) were men; median age was 66 years (IQR: 56-73). One hundred (76.3%) developed AEs. Total AEs were 229, of which 81 were serious adverse events (SAEs). Cure was obtained in 113 cases (86.3%), therapeutic failure occurred in 10 (7.6%), 6 patients died (4.6%), and 2 (1.5%) were lost-to-follow-up. Despite of AEs, most patients were able to complete treatment with appropriate management and monitoring. AEs affect patient quality of life and treatment adherence. Therefore, it is important to identify factors that can predict and prevent them. Clear and detailed information about drug side effects, with instructions to follow in case of AEs, active monitoring at every contact, flexibility and accessibility to healthcare professionals are key factors for therapy success.

Keywords: Adverse events; Nontuberculous mycobacterial lung disease treatment; Treatment outcome.

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Conflict of interest statement

Declarations. Competing interests: The authors declare no competing interests. Institutional review board statement: This study was approved by the Ethics Committee of the National Institute for Infectious Diseases, “L. Spallanzani” IRCCS, with decision n.12 (17 February 2015). All enrolled patients provided written informed consent to the utilization of their anonymized clinical data. All research was performed in accordance with relevant guidelines/regulations. Informed consent was obtained from all participants and/or their legal guardians. Research has been performed in accordance with the the Declaration of Helsinki. Informed consent: Informed consent was obtained from all subjects involved in the study.

Figures

Fig. 1
Fig. 1
Drugs used, number of patients treated (n and %) and exposure time during therapy.
Fig. 2
Fig. 2
Drug used and time of exposure during treatment for slow-growing mycobacteria (SGM), and rapid-growing mycobacteria (RGM).
See this image and copyright information in PMC

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