Dalbavancin utilization registry investigating value and effectiveness (DRIVE): Outcomes report on real-world use

Abstract

ObjectivesDalbavancin has potent activity against Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus, and is approved for treatment of acute bacterial skin and skin structure infections (ABSSSI). We describe real-world use of dalbavancin in patients with ABSSSI, bloodstream infection (BSI), bone and joint infection (BJI), or other infection (OI). MethodsDalbavancin Utilization Registry Investigating Value and Effectiveness (DRIVE) was a phase 4 observational, multicenter, retrospective study of the real-world use of dalbavancin in adults across the United States. Data collected March 2017 – November 2018, at hospitals, intensive care units, and outpatient parenteral antibiotic therapy units, included patient demographics, diagnosis, microbiology, antibiotic use, clinical outcome, and adverse events up to 60 days after the last dose of dalbavancin. Patients were treated entirely at the physicians’ discretion. All patients who received ≥ 1 dose of dalbavancin between February 2016 and the end of the data collection period were included in the safety population. Patients with clear clinical success or failure of dalbavancin treatment, according to definitions similar to those used in the dalbavancin phase 3 trials, were included in the evaluable population and the post-hoc analysis. ResultsThe safety population comprised 1168 patients treated at 31 healthcare sites. Median cumulative dalbavancin dose was 1500 mg for all infection categories, most commonly as 1 infusion; 36.9 % of BSI patients and 58.6 % of BJI patients received ≥ 2 infusions; most were treated as outpatients. Serious adverse drug reactions were reported in 0.7 % of patients overall. Clinical success was achieved in 747/815 (91.7 %) evaluable patients with ABSSSI (BSI, 43/48 [89.6 %]; BJI, 75/87 [86.2 %]; OI, 7/7 [100 %]). ConclusionsDalbavancin demonstrated high rates of real-world clinical success and safety when treating patients for suspected or confirmed Gram-positive infections.