评估疑似脓毒症患者抗生素降阶梯的选择退出方案：一项多中心、随机、对照试验。

Evaluation of an Opt-Out Protocol for Antibiotic De-Escalation in Patients With Suspected Sepsis: A Multicenter, Randomized, Controlled Trial.

机构信息

Department of Medicine, Infectious Diseases, Duke University, Durham, North Carolina, USA.

Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina, USA.

出版信息

Clin Infect Dis. 2023 Feb 8;76(3):433-442. doi: 10.1093/cid/ciac787.

DOI:10.1093/cid/ciac787

PMID:36167851

Abstract

BACKGROUND

Sepsis guidelines recommend daily review to de-escalate or stop antibiotics in appropriate patients. This randomized, controlled trial evaluated an opt-out protocol to decrease unnecessary antibiotics in patients with suspected sepsis.

METHODS

We evaluated non-intensive care adults on broad-spectrum antibiotics despite negative blood cultures at 10 US hospitals from September 2018 through May 2020. A 23-item safety check excluded patients with ongoing signs of systemic infection, concerning or inadequate microbiologic data, or high-risk conditions. Eligible patients were randomized to the opt-out protocol vs usual care. Primary outcome was post-enrollment antibacterial days of therapy (DOT). Clinicians caring for intervention patients were contacted to encourage antibiotic discontinuation using opt-out language. If continued, clinicians discussed the rationale for continuing antibiotics and de-escalation plans. To evaluate those with zero post-enrollment DOT, hurdle models provided 2 measures: odds ratio of antibiotic continuation and ratio of mean DOT among those who continued antibiotics.

RESULTS

Among 9606 patients screened, 767 (8%) were enrolled. Intervention patients had 32% lower odds of antibiotic continuation (79% vs 84%; odds ratio, 0.68; 95% confidence interval [CI], .47-.98). DOT among those who continued antibiotics were similar (ratio of means, 1.06; 95% CI, .88-1.26). Fewer intervention patients were exposed to extended-spectrum antibiotics (36% vs 44%). Common reasons for continuing antibiotics were treatment of localized infection (76%) and belief that stopping antibiotics was unsafe (31%). Thirty-day safety events were similar.

CONCLUSIONS

An antibiotic opt-out protocol that targeted patients with suspected sepsis resulted in more antibiotic discontinuations, similar DOT when antibiotics were continued, and no evidence of harm.

CLINICAL TRIALS REGISTRATION

NCT03517007.

摘要

背景

脓毒症指南建议每天进行评估，以给合适的患者降级或停止使用抗生素。这项随机对照试验评估了一种选择退出方案，以减少疑似脓毒症患者不必要的抗生素使用。

方法

我们评估了 10 家美国医院的非重症监护成人在使用广谱抗生素治疗，但血培养阴性的情况下，有 23 项安全检查排除了有持续全身感染迹象、有疑问或不充分的微生物学数据或有高危情况的患者。符合条件的患者被随机分配到选择退出方案或常规护理组。主要结局是纳入后的抗菌治疗天数（DOT）。联系干预患者的临床医生，使用选择退出语言鼓励停止使用抗生素。如果继续使用，临床医生将讨论继续使用抗生素和降级计划的理由。为了评估那些纳入后无抗生素使用的患者，使用障碍模型提供了 2 个指标：抗生素继续使用的比值比和继续使用抗生素的患者平均 DOT 比值。

结果

在筛选的 9606 名患者中，有 767 名（8%）被纳入。干预组患者继续使用抗生素的可能性降低了 32%（79% vs 84%；比值比，0.68；95%置信区间 [CI]，0.47-0.98）。继续使用抗生素的患者的 DOT 相似（平均值比，1.06；95%CI，0.88-1.26）。接受广谱抗生素治疗的干预组患者较少（36% vs 44%）。继续使用抗生素的常见原因是治疗局部感染（76%）和认为停止使用抗生素不安全（31%）。30 天安全性事件相似。