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.
Nikolay Belev, Andres Tein, Giuseppe Mangialardi, Alessandra Nuti, Giovanni Marino Merlo, Simona Scartoni, Monica Bertolotti, Margherita Lerro, Stefano Margaritora
{"title":"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.","authors":"Nikolay Belev, Andres Tein, Giuseppe Mangialardi, Alessandra Nuti, Giovanni Marino Merlo, Simona Scartoni, Monica Bertolotti, Margherita Lerro, Stefano Margaritora","doi":"10.1093/ofid/ofaf476","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Clinical trials registration: </strong>NCT04042077; 2018-001082-17 (EudraCT).</p>","PeriodicalId":19517,"journal":{"name":"Open Forum Infectious Diseases","volume":"12 9","pages":"ofaf476"},"PeriodicalIF":3.8000,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12406695/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Open Forum Infectious Diseases","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/ofid/ofaf476","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/9/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍：
Open Forum Infectious Diseases provides a global forum for the publication of clinical, translational, and basic research findings in a fully open access, online journal environment. The journal reflects the broad diversity of the field of infectious diseases, and focuses on the intersection of biomedical science and clinical practice, with a particular emphasis on knowledge that holds the potential to improve patient care in populations around the world. Fully peer-reviewed, OFID supports the international community of infectious diseases experts by providing a venue for articles that further the understanding of all aspects of infectious diseases.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
