A Randomized, Observer-Blinded, Active-Controlled, Phase IIIb Study to Compare IV/Oral Delafloxacin Fixed-Dose...

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.

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.

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.

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.

NCT04042077; 2018-001082-17 (EudraCT).