Background Delafloxacin is an intravenous (IV)/oral anionic fluoroquinolone with activity against gram-positive (including methicillin-resistant Staphylococcus aureus [MRSA]), gram-negative, atypical, and anaerobic organisms. It is approved in the United States for acute bacterial skin and skin structure infections (ABSSSIs) caused by designated susceptible gram-positive and gram-negative organisms, and is in development for the treatment of community-acquired bacterial pneumonia. Methods A multicenter, randomized, double-blind trial of 850 adults with ABSSSI compared delafloxacin 300 mg IV every 12 hours for 3 days with a switch to 450 mg oral delafloxacin, to vancomycin 15 mg/kg IV with aztreonam for 5-14 days. The primary endpoint was objective response at 48-72 hours. Investigator-assessed response based on resolution of signs and symptoms at follow-up (day 14 ± 1), and late follow-up (day 21-28) were secondary endpoints. Results In the intent-to-treat analysis set, the objective response was 83.7% in the delafloxacin arm and 80.6% in the comparator arm. Investigator-assessed success was similar at follow-up (87.2% vs 84.4%) and late follow-up (83.5% vs 82.2%). Delafloxacin was comparable to vancomycin + aztreonam in eradication of MRSA at 96.0% vs 97.0% at follow-up. Frequency of treatment-emergent adverse events between the groups was similar. Treatment-emergent adverse events leading to study drug discontinuation was higher in the vancomycin + aztreonam group (1.2% vs 2.4%). Conclusions In ABSSSI patients, IV/oral delafloxacin monotherapy was noninferior to IV vancomycin + aztreonam combination therapy for both the objective response and the investigator-assessed response at follow-up and late follow-up. Delafloxacin was well tolerated as monotherapy in treatment of ABSSSIs. Clinical Trials Registration NCT01984684.

中文翻译：

---

口服德拉帕沙星与万古霉素加氨曲南治疗静脉内急性细菌性皮肤和皮肤结构感染的疗效和安全性比较：一项三期，多国，双盲，随机研究。

背景德拉福沙星是一种静脉（IV）/口服阴离子氟喹诺酮，对革兰氏阳性（包括耐甲氧西林的金黄色葡萄球菌[MRSA]），革兰氏阴性，非典型和厌氧生物具有活性。它在美国被批准用于由指定的易感革兰氏阳性和革兰氏阴性生物引起的急性细菌皮肤和皮肤结构感染（ABSSSI），并且正在开发中，用于治疗社区获得性细菌性肺炎。方法一项对850名ABSSSI成人进行的多中心，随机，双盲试验，比较了每12小时静脉注射地拉非星300 mg，连续3天静脉注射地拉氟沙星的剂量为450 mg，万古霉素15 mg / kg氨曲南静脉注射5-14天的比较。主要终点是在48-72小时的客观反应。次要终点是随访者（第14±1天）和随访后期（第21-28天），根据症状和体征的缓解进行研究者评估的反应。结果在意向性治疗分析组中，地拉氟沙星组的客观反应为83.7％，比较组为80.6％。研究者评估的随访结果（87.2％vs 84.4％）和晚期随访结果（83.5％vs 82.2％）相似。德拉福沙星在根除MRSA方面与万古霉素+阿曲酮相当，为96.0％，而随访时为97.0％。两组之间出现紧急治疗的不良事件发生频率相似。万古霉素+氨曲南组出现的导致研究药物停药的突发治疗不良事件较高（1.2％vs 2.4％）。结论在ABSSSI患者中，在随访和晚期随访中，客观反应和研究者评估的反应均不低于静脉万古霉素+氨曲南联合治疗的静脉/口服氟西沙星单药治疗。德拉福沙星作为单一疗法在ABSSSI的治疗中具有良好的耐受性。临床试验注册NCT01984684。