Shaw George J, Meunier Jason M, Korfhagen Joseph, Wayne Beth, Hart Kimberly, Lindsell Christopher J, Fermann Gregory
Department of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio; Program in Biomedical Engineering, University of Cincinnati, Cincinnati, Ohio.
Department of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio.
J Emerg Med. 2015 Dec;49(6):928-36. doi: 10.1016/j.jemermed.2015.07.026. Epub 2015 Oct 29.
Incidence of methicillin-resistant Staphylococcus aureus (MRSA) is increasing in complicated skin and skin structure infection (cSSSI) presenting to emergency departments (EDs). Treatment is heterogeneous and can require inpatient admission to an observation unit (OU). Vancomycin is commonly used in the OU for treatment, but increasing MRSA resistance to vancomycin suggests the need for alternatives. Daptomycin is an alternative but it is not known how it compares with vancomycin.
This study tested the hypothesis that daptomycin is noninferior to vancomycin for the treatment of cSSSI in an OU, using a relative risk (RR) of 1.3 as the noninferiority limit.
Subjects admitted to an ED-based OU with a diagnosis of cSSSI were eligible. Consenting subjects were randomized 1:1 to intravenous (i.v.) vancomycin at 15 mg/kg dosing every 12 h or i.v. daptomycin at 4 mg/kg once. Subjects were followed until they met objective criteria for discharge home or hospital admission. Discharged patients were prescribed 10-14 days of oral cephalexin and trimethoprim-sulfamethoxazole, or clindamycin if allergic to either of these medications. The primary endpoint was meeting objective discharge criteria with no change in antibiotic therapy or return to the ED for the same cellulitis within 30 days of OU discharge.
There were 100 patients enrolled. RR for satisfying the endpoint was 1.07 (95% confidence interval 0.58-1.98) for daptomycin compared with vancomycin. Hospital admission rates were 36% and 32% for daptomycin and vancomycin treatment, respectively.
Daptomycin was not inferior to vancomycin in the treatment of cSSSI in an OU.
在急诊科就诊的复杂性皮肤和皮肤结构感染（cSSSI）中，耐甲氧西林金黄色葡萄球菌（MRSA）的发病率正在上升。治疗方法多种多样，可能需要住院进入观察病房（OU）。万古霉素在观察病房中常用于治疗，但MRSA对万古霉素的耐药性不断增加，这表明需要替代药物。达托霉素是一种替代药物，但尚不清楚它与万古霉素相比效果如何。
本研究检验了以下假设：在观察病房中，达托霉素治疗cSSSI不劣于万古霉素，非劣效性界限采用相对风险（RR）为1.3。
符合条件的患者为因cSSSI诊断而入住急诊科观察病房的患者。同意参与的患者按1:1随机分组，分别接受每12小时静脉注射（i.v.）15mg/kg万古霉素或静脉注射一次4mg/kg达托霉素。对患者进行随访，直至他们达到出院回家或住院的客观标准。出院患者被开具10 - 14天的口服头孢氨苄和甲氧苄啶 - 磺胺甲恶唑，如果对这两种药物中的任何一种过敏，则开具克林霉素。主要终点是达到客观出院标准，在观察病房出院后30天内抗生素治疗无变化或因同一蜂窝织炎返回急诊科。
共纳入100例患者。与万古霉素相比，达托霉素达到终点的RR为1.07（95%置信区间0.58 - 1.98）。达托霉素和万古霉素治疗的住院率分别为36%和32%。
在观察病房中，达托霉素治疗cSSSI不劣于万古霉素。
