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首页> 外文期刊>Clinical Infectious Diseases >A Randomized, Double‐Blind Trial Comparing Ceftobiprole Medocaril with Vancomycin plus Ceftazidime for the Treatment of Patients with Complicated Skin and Skin‐Structure Infections
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A Randomized, Double‐Blind Trial Comparing Ceftobiprole Medocaril with Vancomycin plus Ceftazidime for the Treatment of Patients with Complicated Skin and Skin‐Structure Infections

机译：头孢比普罗美多卡利与万古霉素加头孢他啶比较的随机，双盲试验治疗复杂皮肤和皮肤结构感染的患者

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Background.A randomized, double‐blind, multicenter trial involving patients with a broad range of complicated skin and skin‐structure infections due to either gram‐positive or gram‐negative bacteria was conducted to compare ceftobiprole monotherapy with treatment with vancomycin plus ceftazidime.nnMethods.Patients were randomized 2:1 to receive ceftobiprole or to receive vancomycin plus ceftazidime. Outcomes were determined at a test‐of‐cure visit (7–14 days after completion of therapy) and were analyzed for all patients with complicated skin and skin‐structure infections, as well as for subgroups, on the basis of major types of infections and severity of disease.nnResults.Among the clinically evaluable and the intent‐to‐treat populations, clinical cure rates at the test‐of‐cure visit were similar in the ceftobiprole and comparator treatment arms (clinical cure rate, 90.5% [439 of 485 patients] and 90.2% [220 of 244 patients] in the clinically evaluable population, respectively; 81.9% [448 of 547 patients] and 80.8% [227 of 281 patients] in the intent‐to‐treat population, respectively). Clinical cure rates in ceftobiprole‐treated patients ranged from 86.2% (125 of 145 patients) among those with diabetes who had foot infections to 93.0% (80 of 86 patients) among those with cellulitis. Among patients treated with ceftobiprole, clinical cure rates were similar among patients from whom gram‐negative bacteria were isolated (87.9% [109 of 124 patients]) and among patients from whom gram‐positive bacteria were isolated (91.8% [292 of 318 patients]) and were not statistically different from the clinical cure rates among comparator‐treated patients (89.7% [61 of 68 patients] and 90.3% [149 of 165 patients], respectively). Rates of adverse events and serious adverse events in the 2 treatment groups were similar.nnConclusions.Ceftobiprole monotherapy is as effective as vancomycin plus ceftazidime for treating patients with a broad range of complicated skin and skin‐structure infections and infections due to gram‐positive and gram‐negative bacteria.
机译：背景：一项随机，双盲，多中心试验，涉及因革兰氏阳性或革兰氏阴性细菌而患有多种复杂皮肤和皮肤结构感染的患者，比较了头孢比普利单药疗法与万古霉素联合头孢他啶治疗的疗效。患者按2：1的比例随机接受头孢比普利或万古霉素加头孢他啶治疗。在就诊测试中（治疗完成后7-14天）确定结局，并根据主要感染类型对所有皮肤和皮肤结构复杂感染的患者以及亚组进行分析结果。在临床可评估人群和意向治疗人群中，头孢比普利和比较治疗组的治愈后就诊治愈率相似（临床治愈率为90.5％[439在临床可评估人群中分别为485例]和90.2％[244例中的220]；在意向性治疗人群中分别为81.9％[547例中的448]和80.8％[281例中的227]。头孢比普利治疗的患者的临床治愈率介于患有脚部感染的糖尿病患者中的86.2％（145名患者中的125名）至蜂窝织炎患者中的93.0％（86名患者中的80名）。在接受头孢比普利治疗的患者中，分离出革兰氏阴性菌的患者（87.9％[124例患者中的109]）和分离出革兰氏阳性菌的患者（91.8％[318个患者中的292人]）的临床治愈率相似]），与经比较者治疗的患者的临床治愈率无统计学差异（分别为89.7％[68名患者中的61]和90.3％[165名患者中的149名]）。两个治疗组的不良事件和严重不良事件发生率相似.nn结论。头孢比普利单药治疗与万古霉素加头孢他啶同等有效，可治疗各种复杂的皮肤和皮肤结构感染以及革兰氏阳性和多发性感染的患者。革兰氏阴性细菌。

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