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改善腹部感染住院患者的经验性抗生素选择:INSPIRE 4 集群随机临床试验

Improving Empiric Antibiotic Selection for Patients Hospitalized With Abdominal Infection: The INSPIRE 4 Cluster Randomized Clinical Trial.

作者信息

Gohil Shruti K, Septimus Edward, Kleinman Ken, Varma Neha, Sands Kenneth E, Avery Taliser R, Mauricio Amarah, Sljivo Selsebil, Rahm Risa, Roemer Kaleb, Cooper William S, McLean Laura E, Nickolay Naoise G, Poland Russell E, Weinstein Robert A, Fakhry Samir M, Guy Jeffrey, Moody Julia, Coady Micaela H, Smith Kim N, Meador Brittany, Froman Allison, Eibensteiner Katyuska, Hayden Mary K, Kubiak David W, Burks Chenette, Burgess L Hayley, Calderwood Michael S, Perlin Jonathan B, Platt Richard, Huang Susan S

机构信息

Division of Infectious Diseases, University of California, Irvine School of Medicine, Irvine.

Department of Population Medicine, Harvard Pilgrim Healthcare Institute, Harvard Medical School, Boston, Massachusetts.

出版信息

JAMA Surg. 2025 Apr 10. doi: 10.1001/jamasurg.2025.1108.

Abstract

IMPORTANCE

Empiric extended-spectrum antibiotics are routinely prescribed for over a million patients hospitalized annually with abdominal infection despite low likelihoods of infection with multidrug-resistant organisms (MDROs).

OBJECTIVE

To evaluate whether computerized provider order entry (CPOE) prompts providing patient- and pathogen-specific MDRO infection risk estimates can reduce empiric extended-spectrum antibiotics for non-critically ill patients admitted with abdominal infection.

DESIGN, SETTING, AND PARTICIPANTS: This 92-hospital cluster randomized clinical trial assessed the effect of an antibiotic stewardship bundle with CPOE prompts vs routine stewardship on antibiotic selection during the first 3 hospital days (empiric period) in non-critically ill adults hospitalized with abdominal infection. The trial population included adults (≥18 years) treated with empiric antibiotics for abdominal infection in non-intensive care units (ICUs). The trial periods included a 12-month baseline from January to December 2019 and an intervention period from January to December 2023.

INTERVENTION

CPOE prompts recommending standard-spectrum antibiotics in patients prescribed extended-spectrum antibiotics during the empiric period if the patient's estimated absolute risk of MDRO abdominal infection was less than 10%, coupled with feedback and education.

MAIN OUTCOMES AND MEASURES

The primary outcome was empiric extended-spectrum antibiotic days of therapy. Safety outcomes: days to ICU transfer and hospital length of stay. Analyses compared differences between baseline and intervention periods across strategies.

RESULTS

Among 92 hospitals with 198 480 patients, mean (SD) age was 60 (19) years and 118 723 (59.8%) were female. The trial included 93 476 and 105 004 patients hospitalized with abdominal infection during the baseline and intervention periods, respectively. Receipt of any empiric extended-spectrum antibiotics for the routine care group was 48.2% (22 519 of 46 725) during baseline and 50.5% (27 452 of 54 384) during intervention vs 47.8% (22 367 of 46 751) and 37.6% (19 010 of 50 620) for the CPOE bundle group. The group receiving CPOE prompts had a 35% relative reduction (rate ratio, 0.65; 95% CI, 0.60-0.71; P < .001) in empiric extended-spectrum antibiotic days of therapy vs routine care (raw absolute reduction between baseline and intervention periods was -169 for the CPOE bundle vs -20 for routine care). Hospital length of stay was noninferior to routine care (0.1 days longer during intervention; mean [SD], baseline, 5.4 [3.4] days vs intervention, 5.5 [3.5] days; hazard ratio [HR], 1.02; 90% CI, 0.99-1.06), and mean days to ICU transfer in the CPOE group was indeterminate (both groups 0.2 days longer during intervention; HR, 1.10; 90% CI, 0.99-1.23).

CONCLUSIONS AND RELEVANCE

CPOE prompts recommending empiric standard-spectrum antibiotics (coupled with education and feedback) for patients admitted with abdominal infection who have low risk for MDRO infection significantly reduced extended-spectrum antibiotics without increasing ICU transfers or length of stay.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT05423743.

摘要

重要性

尽管每年有超过100万因腹部感染住院的患者感染多重耐药菌(MDRO)的可能性较低,但经验性使用广谱抗生素仍是常规做法。

目的

评估计算机化医嘱录入(CPOE)提示提供患者和病原体特异性MDRO感染风险估计值是否可以减少因腹部感染入院的非危重症患者的经验性广谱抗生素使用。

设计、设置和参与者:这项在92家医院进行的整群随机临床试验评估了在因腹部感染住院的非危重症成年人中,包含CPOE提示的抗生素管理方案与常规管理方案对住院前3天(经验期)抗生素选择的影响。试验人群包括在非重症监护病房(ICU)接受经验性抗生素治疗腹部感染的成年人(≥18岁)。试验期包括2019年1月至12月的12个月基线期和2023年1月至12月的干预期。

干预措施

如果患者MDRO腹部感染的估计绝对风险低于10%,CPOE提示在经验期为开具广谱抗生素的患者推荐标准谱抗生素,并提供反馈和教育。

主要结局和指标

主要结局是经验性广谱抗生素治疗天数。安全性结局:转入ICU的天数和住院时间。分析比较了各策略在基线期和干预期之间的差异。

结果

在92家医院的198480名患者中,平均(标准差)年龄为60(19)岁,女性有118723名(59.8%)。试验分别纳入了基线期和干预期因腹部感染住院的93476名和105004名患者。常规护理组在基线期接受任何经验性广谱抗生素治疗的比例为48.2%(46725名中的22519名),干预期为50.5%(54384名中的27452名);而CPOE方案组在基线期和干预期分别为47.8%(46751名中的22367名)和37.6%(50620名中的19010名)。与常规护理相比,接受CPOE提示的组经验性广谱抗生素治疗天数相对减少了35%(率比,0.65;95%置信区间,0.60 - 0.71;P <.001)(CPOE方案组基线期和干预期之间的绝对减少量为 -169,常规护理组为 -20)。住院时间不劣于常规护理(干预期长0.1天;平均[标准差],基线期,5.4[3.4]天,干预期,5.5[3.5]天;风险比[HR],1.02;90%置信区间,0.99 - 1.06),CPOE组转入ICU的平均天数不确定(两组在干预期均长0.2天;HR,1.10;90%置信区间,0.99 - 1.23)。

结论和意义

对于MDRO感染风险低的因腹部感染入院患者,CPOE提示推荐经验性标准谱抗生素(并结合教育和反馈)可显著减少广谱抗生素使用,且不增加转入ICU的次数或住院时间。

试验注册

ClinicalTrials.gov标识符:NCT05423743。

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