一项随机、观察者盲法、活性对照、IIIb期研究，旨在比较静脉注射/口服德拉氟沙星固定剂量单药疗法与最佳可用治疗方案在微生物富集的手术部位感染人群中的疗效：DRESS研究。
A Randomized, Observer-Blinded, Active-Controlled, Phase IIIb Study to Compare IV/Oral Delafloxacin Fixed-Dose Monotherapy With Best Available Treatments in a Microbiologically Enriched Population With Surgical Site Infections: The DRESS Study.
作者信息
Belev Nikolay, Tein Andres, Mangialardi Giuseppe, Nuti Alessandra, Marino Merlo Giovanni, Scartoni Simona, Bertolotti Monica, Lerro Margherita, Margaritora Stefano
机构信息
University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv," Plovdiv, Bulgaria.
Department of Surgery, Tartu University Hospital, Tartu, Estonia.
出版信息
Open Forum Infect Dis. 2025 Aug 29;12(9):ofaf476. doi: 10.1093/ofid/ofaf476. eCollection 2025 Sep.
BACKGROUND
Surgical site infections (SSIs) are the most common skin and skin structure infections and are mostly polymicrobial, requiring hospitalization and broad-spectrum antibiotics. This clinical trial evaluated the noninferiority of delafloxacin vs best available therapy (BAT) for the treatment of superficial or deep incisional SSI following a cardiothoracic/related leg or abdominal surgical procedure.
METHODS
In this randomized, observer-blinded, active-controlled, parallel-group, multicenter, phase IIIb study, patients with SSI were randomized 1:1 to receive delafloxacin 300 mg intravenous (IV)/450 mg oral (OS) or BAT IV/OS (vancomycin or linezolid for cardiothoracic SSI, piperacillin/tazobactam or tigecycline for abdominal SSI). The primary end point was clinical success, defined as the clinical response (cure or improved) at test of cure (TOC), performed 7-14 days after end of treatment (EOT) visit. Secondary end points were clinical success at EOT, sustained clinical response at last follow-up (LFU), microbiological response, and safety.
RESULTS
Thi study enrolled 266 patients (delafloxacin = 134; BAT = 132) with comparable baseline characteristics between the 2 treatment arms. Delafloxacin clinical success was noninferior vs BAT at TOC visit (91.8% vs 90.2%, respectively). Similar efficacy was confirmed at LFU (91.8% delafloxacin; 87.9% BAT). Comparable microbiological response was obtained with delafloxacin (89.5%) and BAT (79.4%). Delafloxacin and BAT demonstrated comparable treatment adverse event rates (23.9% and 19.7%, respectively), mostly mild-to-moderate gastrointestinal reactions.
CONCLUSIONS
This study provided new data on delafloxacin in SSIs, covering the need for effective empiric treatment against the wide spectrum of pathogens involved in these infections.
CLINICAL TRIALS REGISTRATION
NCT04042077; 2018-001082-17 (EudraCT).
背景
手术部位感染（SSIs）是最常见的皮肤及皮肤结构感染，大多为多种微生物感染，需要住院治疗并使用广谱抗生素。本临床试验评估了德拉氟沙星与最佳可用治疗方案（BAT）治疗心胸/相关腿部或腹部手术后浅表或深部切口SSIs的非劣效性。
方法
在这项随机、观察者盲法、活性对照、平行组、多中心IIIb期研究中，SSIs患者按1:1随机分组，接受300mg静脉注射（IV）/450mg口服（OS）的德拉氟沙星或BAT IV/OS（心胸SSIs用万古霉素或利奈唑胺，腹部SSIs用哌拉西林/他唑巴坦或替加环素）。主要终点为临床成功，定义为在治疗结束（EOT）访视后7 - 14天进行的治愈试验（TOC）时的临床反应（治愈或改善）。次要终点为EOT时的临床成功、最后一次随访（LFU）时的持续临床反应、微生物学反应和安全性。
结果
本研究纳入了266例患者（德拉氟沙星组 = 134例；BAT组 = 132例），两个治疗组的基线特征具有可比性。在TOC访视时，德拉氟沙星的临床成功率不劣于BAT（分别为91.8%和90.2%）。在LFU时也证实了类似的疗效（德拉氟沙星组为91.8%；BAT组为87.9%）。德拉氟沙星（89.5%）和BAT（79.4%）的微生物学反应相当。德拉氟沙星和BAT的治疗不良事件发生率相当（分别为23.9%和19.7%），主要为轻度至中度胃肠道反应。
结论
本研究提供了关于德拉氟沙星治疗SSIs的新数据，满足了针对这些感染中涉及的广泛病原体进行有效经验性治疗的需求。
临床试验注册
NCT04042077；2018 - 001082 - 17（欧盟临床试验注册号）
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