Stryjewski Martin E, Chu Vivian H, O'Riordan William D, Warren Brian L, Dunbar Lala M, Young David M, Vallée Marc, Fowler Vance G, Morganroth Joel, Barriere Steven L, Kitt Michael M, Corey G Ralph
Division of Infectious Diseases, Duke University Medical Center, Durham, North Carolina, USA.
Antimicrob Agents Chemother. 2006 Mar;50(3):862-7. doi: 10.1128/AAC.50.3.862-867.2006.
Telavancin is a bactericidal lipoglycopeptide with a multifunctional mechanism of action. We conducted a randomized, double blind, active-control phase II trial. Patients > or = 18 years of age with complicated skin and skin structure infections caused by suspected or confirmed gram-positive organisms were randomized to receive either telavancin at 10 mg/kg intravenously every 24 h (q24h) or standard therapy (antistaphylococcal penicillin at 2 g q6h or vancomycin at 1 g q12h). A total of 195 patients were randomized and received at least one dose of study medication. Clinical success rates were similar in all analysis populations at test of cure. In microbiologically evaluable patients with Staphylococcus aureus at baseline (n = 91), 96% of the telavancin group and 90% of the standard-therapy group were cured. Among patients with methicillin-resistant S. aureus (MRSA) at baseline (n = 45), clinical cure rates were also 96% for telavancin and 90% for standard therapy. Microbiologic eradication in patients with S. aureus infection was better with telavancin compared to standard therapy (92% versus 78%, P = 0.07) and significantly better in patients with MRSA (92% versus 68%; P = 0.04). Therapy was discontinued for an adverse event (AE) in 6% and 3% of the patients receiving telavancin and standard therapy, respectively. Except for two cases of rash in the telavancin group, these AEs were similar in type and severity in the two groups. The overall incidences and severities of AEs and laboratory abnormalities were similar between the two groups. These data support the ongoing studies assessing the efficacy and safety of telavancin in the treatment of serious gram-positive infections, particularly involving MRSA.
替考拉宁是一种具有多功能作用机制的杀菌性脂糖肽。我们进行了一项随机、双盲、活性对照的II期试验。年龄大于或等于18岁、由疑似或确诊的革兰氏阳性菌引起的复杂性皮肤和皮肤结构感染患者被随机分为两组，一组每24小时静脉注射10mg/kg替考拉宁（每24小时一次），另一组接受标准治疗（2g抗葡萄球菌青霉素每6小时一次或1g万古霉素每12小时一次）。共有195名患者被随机分组并接受了至少一剂研究药物。在所有分析人群的治愈试验中，临床成功率相似。在基线时患有金黄色葡萄球菌的微生物学可评估患者（n = 91）中，替考拉宁组的治愈率为96%，标准治疗组为90%。在基线时患有耐甲氧西林金黄色葡萄球菌（MRSA）的患者（n = 45）中，替考拉宁组和标准治疗组的临床治愈率也分别为96%和90%。与标准治疗相比，替考拉宁治疗金黄色葡萄球菌感染患者的微生物清除效果更好（92%对78%，P = 0.07），在MRSA患者中显著更好（92%对68%；P = 0.04）。接受替考拉宁和标准治疗的患者中，分别有6%和3%因不良事件（AE）而停药。除替考拉宁组有两例皮疹外，两组的这些不良事件在类型和严重程度上相似。两组不良事件和实验室异常的总体发生率和严重程度相似。这些数据支持正在进行的评估替考拉宁治疗严重革兰氏阳性感染，特别是涉及MRSA感染的疗效和安全性的研究。
