Efficacy and safety of dalbavancin in the treatment of acute bacterial skin and skin structure infections (ABSSSIs) and other infections in a real-life setting: data from an Italian observational multicentric study (DALBITA study).

Objectives We evaluated the efficacy and safety of dalbavancin in ABSSSI and 'other sites' infections' (OTA). Methods Observational study involving 11 Italian hospitals including patients that received >= 1 dose of dalbavancin in 2016-2019. The outcome was end-of-treatment efficacy and safety in ABSSSI and OTA in a real-life setting. Results 206 patients enrolled (males 50%, median age 62 [IQR 50-76] years), 60.2% ABSSSI, 39.8% OTA. 69.7% ABSSSIvs90.7% OTA (p = 0.003) and 46.3% ABSSSIvs37.2% OTA (p = 0.786) received previous and concomitant antibiotics, respectively. 82.5% reached clinical cure . Eleven (5.4%) patients had non-serious adverse events (AE). OTA patients showed longer hospitalization (13.5 days, 5.5-22vs3, 0-11.7; p<0.0001) and received longer previous (18 days, 9-30vs11, 7-19; p = 0.007)/concomitant antibiotic treatments (21 days, 14-52vs11, 8-14; p < 0.0001), compared to ABSSSI. ABSSSI and OTA showed similar efficacy (85.5%vs75%, p = 0.459) and safety (no AE: 81.5%vs64.3%, p = 0.258); efficacy was independent of previous/concomitant therapies. Conclusions Dalbavancin demonstrated a success rate of >80%, with similar efficacy/safety in ABSSSI and off-label indications. The preferential use of dalbavancin as second-line or combination therapy would seem to suggest the need for in-depth studies focused on its off-label use.