Efficacy of dalbavancin was similar between outpatient and inpatient groups.
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Dalbavancin had a similar safety profile in the inpatient and outpatient setting.
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Outcomes were similar among patients receiving single-dose or two-dose dalbavancin.
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Outpatients reported greater satisfaction with antibiotic treatment and care.
Abstract
Objectives
Treatment of acute bacterial skin and skin structure infections (ABSSSIs) in the outpatient setting has potential advantages. We performed a subanalysis of outcomes for patients treated as outpatients versus inpatients with dalbavancin, a long-acting lipoglycopeptide, in a phase 3 clinical trial of ABSSSI.
Methods
The study was a double-blind trial of patients with ABSSSI randomised to receive dalbavancin 1500 mg intravenously as a single dose or two doses (1000 mg followed by 500 mg a week later). The primary endpoint was ≥20% reduction in erythema at 48–72 h after the start of therapy. Patient satisfaction and preference for antibiotic treatment and care setting were measured using the 10-item Skin and Soft Tissue Infection (SSTI) questionnaire at Day 14.
Results
A total of 698 patients were randomised (386 treated as outpatients and 312 as inpatients). Outpatients were more likely to be younger and to have major abscess or traumatic wound infection; inpatients were more likely to have cellulitis as the type of ABSSSI, to meet SIRS criteria and to have elevated plasma lactate at baseline. Efficacy and safety outcomes at 48–72 h, Days 14 and 28 were similar between patients treated in the outpatient and inpatient setting with either the single-dose or two-dose regimen. Outpatients reported significantly greater convenience and satisfaction with antibiotic treatment and care setting compared with inpatients (P < 0.001).
Conclusion
Single-dose dalbavancin is an effective treatment option for outpatients with ABSSSI and is associated with a high degree of patient treatment satisfaction and convenience.
Presented in part at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), 9–12 April 2016, Amsterdam, the Netherlands [poster P0901] and the American Society of Health-System Pharmacists (ASHP) Mid-Year Clinical Meeting, 4–8 December 2016, Las Vegas, NV [poster 6-108].