单剂oritavancin治疗急性细菌性皮肤感染。

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科里GR, Kabler H,用P,古普塔年代,Overcash JS, Porwal,佐丹奴P, Lucasti C,佩雷斯,好的年代,江H, Moeck G, baillie gifford W

单剂oritavancin治疗急性细菌性皮肤感染。

郑传经地中海J。2014年6月5日,370 (23):2180 - 90。doi: 10.1056 / NEJMoa1310422。

PubMed ID

24897083 (在PubMed

]

文摘

背景:Oritavancin lipoglycopeptide杀菌活动对革兰氏阳性细菌。其浓度活性,延长半衰期允许单剂治疗。方法:我们进行了一项随机、双盲试验中,成人急性细菌性皮肤和皮肤结构感染获得单个静脉注射剂量1200毫克的oritavancin或静脉注射万古霉素的疗程为7到10天每天两次。三个功效端点检测非劣性。主要复合终点被定义为停止散布或减少病灶大小,没有发烧,不需要政府救援的抗生素管理oritavancin 48到72小时后。次要终点是临床治疗结束后7 - 14天治疗,由研究人员,减少损伤的大小20%或更多oritavancin管理后48到72小时。结果:修改后的意向处理人口由475病人oritavancin和479名患者接受万古霉素。所有三个有效性终点遇见了指定的非边缘10百分点oritavancin与万古霉素:主要终点,分别为82.3%和78.9%(95%可信区间[CI]为区别,-1.6 - 8.4);investigator-assessed临床治愈,分别为79.6%和80.0%(95%可信区间的差异,-5.5 - 4.7);和比例的减少患者病变面积20%以上,分别为86.9%和82.9%(95%可信区间的差异,-0.5 - 8.6)。 Efficacy outcomes measured according to type of pathogen, including methicillin-resistant Staphylococcus aureus, were similar in the two treatment groups. The overall frequency of adverse events was also similar, although nausea was more common among those treated with oritavancin. CONCLUSIONS: A single dose of oritavancin was noninferior to twice-daily vancomycin administered for 7 to 10 days for the treatment of acute bacterial skin and skin-structure infections caused by gram-positive pathogens. (Funded by the Medicines Company; SOLO I ClinicalTrials.gov number, NCT01252719.).

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药物

Oritavancin