REDS study: Retrospective effectiveness study of dalbavancin and other standard of care of the same IV antibiotic class in patients with ABSSSI.

OBJECTIVES: Acute bacterial skin and skin-structure infections (ABSSSIs) are a common source of morbidity in both the community and hospital settings. The current standard of care (SoC) requires multiple-dose intravenous (IV) regimens, which are associated with high hospitalisation rates, concomitant event risks and costs. Dalbavancin is a lipoglycopeptide, long-acting antibiotic that is effective against Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA). Dalbavancin allows treatment of ABSSSIs with a single-shot IV administration or once weekly for 2 weeks, enabling clinicians to treat patients in an outpatient setting or to shorten the length of hospital stay. METHODS: This multicentre, observational, retrospective study compared hospitalised patients who received dalbavancin and patients treated with the three most used IV antibiotics of the same or similar class: vancomycin, teicoplanin and daptomycin. The primary outcome was the time to discharge after starting the study antibiotics. RESULTS: The primary endpoint, time to discharge from the study therapy start, was measured for both groups: the median number of days was 6.5 in the dalbavancin group vs. 11.0 days in the SoC group. Moreover, in subpopulations of patients receiving one or more concomitant antibiotics active for Gram-positives, MRSA and patients with the most prevalent comorbidity (i.e., diabetes), the advantage of dalbavancin in terms of length of stay was confirmed, with a halved time to discharge or more. Safety data on dalbavancin were consistent with data collected in clinical trials. No serious adverse drug reactions related to dalbavancin were reported and most of them were classified as skin and subcutaneous tissue disorders. One serious ADR was reported for daptomycin. CONCLUSIONS: Although the analysis was only descriptive, it can be concluded that dalbavancin may enable a remarkable reduction in length of hospital stay, also confirming the clinical effectiveness and good safety profile demonstrated in clinical trials in a real-world setting.

Skin infections in Europe: a retrospective study of incidence, patient characteristics and practice patterns.

OBJECTIVE: Acute bacterial skin and skin structure infections (ABSSSIs) are associated with considerable morbidity and a heavy healthcare burden. The primary objectives of this two-phase study were to determine the incidence of skin infections and ABSSSIs in hospitalized patients (Phase A), and to describe the characteristics and treatment of hospitalized patients with ABSSSIs (Phase B). METHODS: This non-interventional, retrospective study was based on data collected from adult patients hospitalized for skin infections in six European countries (Czech Republic, Greece, Italy, Portugal, Russia and Spain) between January 2014 and June 2016. RESULTS: In Phase A, the total hospital incidence of skin infections and ABSSSIs was 2.4 and 1.8 per 1000 patient-days, respectively. Overall, 73.6% of 50,469 hospitalizations for skin infections were for ABSSSIs. Among the 750 patients with ABSSSIs included in Phase B, Gram-positive bacteria were isolated in 24.9%, most commonly methicillin-susceptible Staphylococcus aureus (11.5%). Empirical therapy was administered to 98.1% of patients, most often with a penicillin, with or without a ß-lactamase inhibitor (42.1%). Complete cure was achieved in 46.5% and 34.5% of patients after initial treatment and treatment modification, respectively. Overall, 22.7% of patients had at least one additional ABSSSI-related hospitalization, 47.1% of patients visited the emergency room, 19.3% of patients visited primary care clinics, and 34.8% of patients visited a specialist. CONCLUSION: Treatment of ABSSSIs in Europe is associated with a heavy healthcare burden, highlighting the need for optimized management strategies that may reduce healthcare utilization.