Wilke Michael, Heinlein Wolfgang, Stiefenhofer Luis, Bodmann Klaus-Friedrich
inspiring-health GmbH, Munich, Germany.
Kliniken Nordoberpfalz AG, Klinikum Weiden, Germany.
GMS Infect Dis. 2020 Dec 15;8:Doc25. doi: 10.3205/id000069. eCollection 2020.
Sepsis and bloodstream infections pose severe challenges in intensive care. Early reliable diagnosis is the key to successful therapy. The objective of the study presented here was to investigate the clinical and economical effects of the new Pheno BC test, which allows bacteria identification (ID) and antimicrobial susceptibility testing (AST) in approximately 7 hours after a blood culture becomes positive (BC+). Historically controlled interventional study. Population: patients with BC+ and ICU admission. Inadequate initial antimicrobial therapy (IAT) is need of therapy change based on result. Prospectively the new test was used in addition. Primary endpoint: time-to-result in hours. Contribution margin (CM) i.e. revenue - costs was computed. All patients formed the intention-to-treat population (ITT). Patients with complete cost data formed the modified ITT group (mITT). CM results were calculated for mITT and PP. Further analyses: length-of-stay (LOS) and mortality. 223 historical and 200 prospective patients were included. Time to result (ITT) was shortened by 51.1 hours (83 vs. 31.9; p<0.001). Overall savings (mITT) were 257,100 € (-301,264 € vs. -44,164 €). 143 of 181 (79%) patients had a test performed, 126 of 143 (88%) having a clinically useable result. 40 (32%) had IAT vs. 65 (29%) in the historic cohort. Median time to AST in PP was shortened by 61.7 hours (89.5 vs. 27.8; p<0.001). LOS was shortened 7 days (28 vs. 19; p=0.226) and mortality was 8% (40.5% vs. 32.5%; p=0.440) lower. Median CM +3,074.80 € per case (-2,350.50 € vs. +724.70 €; p=0.040). The new Pheno ID+AST test leads to faster and clinically meaningful results and saves money by shortening LOS on the ICU.
脓毒症和血流感染在重症监护中构成严峻挑战。早期可靠诊断是成功治疗的关键。本文所呈现研究的目的是调查新型Pheno BC检测的临床和经济效果，该检测能在血培养呈阳性（BC+）后约7小时内实现细菌鉴定（ID）和抗菌药物敏感性测试（AST）。历史对照干预性研究。研究对象：血培养呈阳性且入住重症监护病房的患者。初始抗菌治疗不足（IAT）时需要根据结果改变治疗方案。前瞻性地额外使用新型检测。主要终点：以小时为单位的得出结果时间。计算贡献毛利（CM），即收入减去成本。所有患者构成意向性治疗人群（ITT）。拥有完整成本数据的患者构成改良意向性治疗组（mITT）。针对mITT和符合方案集（PP）计算CM结果。进一步分析：住院时长（LOS）和死亡率。纳入了223例历史对照患者和200例前瞻性患者。得出结果的时间（ITT）缩短了51.1小时（83小时对31.9小时；p<0.001）。总体节省费用（mITT）为257,100欧元（-301,264欧元对-44,164欧元）。181例患者中有143例（79%）进行了检测，143例中有126例（88%）得到了临床可用结果。40例（32%）存在初始抗菌治疗不足，而历史队列中为65例（29%）。符合方案集中AST的中位时间缩短了61.7小时（89.5小时对27.8小时；p<0.001）。住院时长缩短了7天（28天对19天；p=0.226），死亡率降低了8%（40.5%对32.5%；p=0.440）。每例患者的中位CM为+3,074.80欧元（-2,350.50欧元对+724.70欧元；p=0.040）。新型Pheno ID+AST检测能带来更快且具有临床意义的结果，并通过缩短在重症监护病房的住院时长节省费用。
