Allergan plc, 5 Giralda Farms, Madison, NJ 07940, USA.
Allergan plc, 5 Giralda Farms, Madison, NJ 07940, USA.
J Glob Antimicrob Resist. 2019 Jun;17:60-65. doi: 10.1016/j.jgar.2019.02.007. Epub 2019 Feb 20.
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.
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.
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).
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.
在门诊环境下治疗急性细菌性皮肤和皮肤结构感染(ABSSSI)具有潜在优势。我们对一项 3 期 ABSSSI 临床试验中接受达巴万星(一种长效糖肽类抗生素)治疗的患者的门诊和住院治疗结局进行了亚组分析。
这是一项 ABSSSI 患者的双盲试验,患者随机接受达巴万星 1500mg 静脉注射单剂量或两剂(1000mg 后一周后 500mg)。主要终点是治疗开始后 48-72 小时红斑减少≥20%。在第 14 天,使用 10 项皮肤和软组织感染(SSTI)问卷评估患者对抗生素治疗和护理环境的满意度和偏好。
共有 698 名患者被随机分组(386 名门诊治疗,312 名住院治疗)。门诊患者更年轻,更可能患有大脓肿或创伤性伤口感染;住院患者更可能患有蜂窝织炎型 ABSSSI,符合 SIRS 标准,且基线时血浆乳酸水平升高。门诊和住院患者接受单剂量或两剂量方案治疗,在 48-72 小时、第 14 天和第 28 天的疗效和安全性结局相似。与住院患者相比,门诊患者报告抗生素治疗和护理环境的便利性和满意度显著更高(P<0.001)。
单剂量达巴万星是 ABSSSI 门诊患者的有效治疗选择,与患者高度的治疗满意度和便利性相关。