Clinical use of dalbavancin in the Italian SUSANA cohort (SUrveillance of SAfety and outcome of New Antibiotics).

The purpose of the study was to evaluate the therapeutic success and adverse events (AEs) of dalbavancin on-label and off-label use in clinical practice. This was a retrospective, observational, multicentre study that enrolled consecutive patients treated with dalbavancin from January 2017 to May 2024 in the Italian SUSANA cohort. Therapeutic success was defined as clinical cure or infection control if chronic suppressive therapy was performed. Risk factors for treatment failure were evaluated using a logistic regression model. A total of 281 patients were enrolled in the study. On-label administration occurred in 162 (57.6%) cases and off-label in 119 (42.6%). The main off-label prescriptions included 29 cases of osteomyelitis and 25 cases of prosthetic joint infections. Dalbavancin was used mainly as empirical therapy (70.4% of cases) in the on-label group, while in the off-label group as targeted therapy for methicillin-resistant Staphylococcus aureus (29.4%). The therapeutic success rate was similar in both groups (82.7% on-label versus 84.0% off-label). Only one adverse event caused discontinuation of treatment in the on-label group. In addition, one grade-3 AE was observed in each cohort, without treatment interruption. Dalbavancin was widely used in clinical practice for on-label and off-label indications with a comparable success rate of 82.8% and 84.0%, respectively, and a good safety profile.