eStudySite, 6367 Alvarado Court, Suite 300, San Diego, CA 92120, USA.
Artemis Research Group, 770 Washington Street, Suite 300, San Diego, CA 92103, USA.
Int J Infect Dis. 2015 Jan;30:67-73. doi: 10.1016/j.ijid.2014.10.009. Epub 2014 Oct 30.
A randomized, double-blind, multicenter trial was done to compare two doses of delafloxacin with tigecycline in patients with various complicated skin and skin-structure infections (wound infections following surgery, trauma, burns, or animal/insect bites, abscesses, and cellulitis).
Patients were randomized 1:1:1 to receive delafloxacin 300mg intravenous (IV) every 12h, delafloxacin 450mg IV every 12h, or tigecycline 100mg IV×1, followed by 50mg IV every 12h; randomization was stratified by infection type. Duration of therapy was 5-14 days. The primary efficacy analysis, performed on the clinically evaluable (CE) population at the test-of-cure (TOC) visit (14-21 days after the final dose of study drug), compared clinical response rates in the delafloxacin and tigecycline arms. Clinical response rates in the two delafloxacin arms were also compared.
Among CE patients, clinical cure rates at TOC visit were similar in the delafloxacin and tigecycline arms (94.3%, 92.5%, and 91.2%, respectively in delafloxacin 300-mg, delafloxacin 450-mg, and tigecycline arms). Overall, the most frequent adverse events were nausea, vomiting, and diarrhea; the 300-mg delafloxacin arm was the best-tolerated regimen.
Delafloxacin was similarly effective as tigecycline for a variety of complicated skin and skin-structure infections and was well tolerated. (Clinicaltrials.gov NCT 0719810).
一项随机、双盲、多中心试验比较了两种剂量的德拉沙星与替加环素治疗各种复杂皮肤和皮肤结构感染（手术后、创伤、烧伤或动物/昆虫咬伤、脓肿和蜂窝织炎引起的伤口感染）的疗效。
患者按 1:1:1 随机分为三组，分别接受 300mg 静脉注射（IV）每 12h 一次的德拉沙星、450mg IV 每 12h 一次的德拉沙星或 100mg IV×1 后 50mg IV 每 12h 的替加环素；随机分组按感染类型分层。治疗持续时间为 5-14 天。主要疗效分析在治疗结束（最后一次研究药物后 14-21 天）的临床可评估（CE）人群中进行，比较了德拉沙星和替加环素组的临床缓解率。还比较了两个德拉沙星组之间的临床缓解率。
在 CE 患者中，TOE 访视时的临床治愈率在德拉沙星和替加环素组相似（300mg 德拉沙星组、450mg 德拉沙星组和替加环素组分别为 94.3%、92.5%和 91.2%）。总体而言，最常见的不良事件是恶心、呕吐和腹泻；300mg 德拉沙星组的耐受性最好。
德拉沙星与替加环素治疗各种复杂皮肤和皮肤结构感染的疗效相似，且耐受性良好。（Clinicaltrials.gov NCT 0719810）。
