实施接触预防措施能否降低 ICU 获得性铜绿假单胞菌感染的发生率？DPCPYO（铜绿假单胞菌感染患者的检测和接触预防措施）整群随机交叉试验。

Do Contact Precautions Reduce the Incidence of Intensive Care Unit-Acquired Pseudomonas aeruginosa Infections? The DPCPYO (Detection and Contact Precautions for Patients With P. aeruginosa) Cluster-Randomized Crossover Trial.

机构信息

Infection Control Department, University Hospital of Besançon, Besançon, France.

UMR 6249 Chrono-Environnement, University of Bourgogne-Franche-Comte, Besançon, France.

出版信息

Clin Infect Dis. 2021 Nov 2;73(9):e2781-e2788. doi: 10.1093/cid/ciaa1663.

DOI:10.1093/cid/ciaa1663

PMID:33137174

Abstract

BACKGROUND

The issue of contact precautions as contributory factors for reducing Pseudomonas aeruginosa (Pa) infections in intensive care units (ICUs) remains questioned. We evaluated the impact of the addition of contact precautions to standard precautions for Pa-positive patients on incidence of ICU-acquired Pa infections.

METHODS

In this multicenter, cluster-randomized crossover trial, 10 French ICUs were randomly assigned (1:1) to sequence 0-1 (6-month control period [CP]/3-month washout period/6-month intervention period [IP]) or sequence 1-0 (6-month IP/3-month washout period/6-month CP). A surveillance screening program for Pa was implemented. Competing-risks regression models were built with death and discharge without the occurrence of ICU-acquired Pa infection (the primary outcome) as competing events. Models were adjusted for within-ICU correlation and patient- and ICU-level covariates. The Simpson diversity index (SDI) and transmission index (TI) of Pa isolates were derived from pulsed-field gel electrophoresis typing.

RESULTS

Within recruited ICUs, the cumulative incidence and incidence rate of ICU-acquired Pa infections were 3.38% (55/1625) versus 3.44% (57/1658) and 3.31 versus 3.52 per 1000 patient-days at risk during the CP and IP, respectively. Multivariable models indicated that the intervention did not significantly change the cumulative incidence (subdistribution hazard ratio, .91; 95% confidence interval [CI], .49-1.67; P = .76) or rate (cause-specific hazard ratio, 1.36; 95% CI, .71-2.63; P = .36) of the primary outcome. SDI and TI did not significantly differ between CP and IP.

CONCLUSIONS

The addition of contact precautions to standard precautions for Pa-positive patients with a surveillance screening program does not significantly reduce ICU-acquired Pa infections in non-outbreak situations. Clinical Trials Registration. ISRCTN92710225.

摘要

背景

接触预防作为减少重症监护病房（ICU）中铜绿假单胞菌（Pa）感染的因素之一，其作用仍存在争议。我们评估了在 Pa 阳性患者中，将接触预防措施添加到标准预防措施中对 ICU 获得性 Pa 感染发生率的影响。

方法

在这项多中心、集群随机交叉试验中，10 家法国 ICU 被随机分配（1:1）到序列 0-1（6 个月的对照期[CP]/3 个月的洗脱期/6 个月的干预期[IP]）或序列 1-0（6 个月的 IP/3 个月的洗脱期/6 个月的 CP）。实施了 Pa 的监测筛查计划。使用竞争风险回归模型，以死亡和无 ICU 获得性 Pa 感染（主要结局）发生的出院作为竞争事件。模型调整了 ICU 内相关性和患者及 ICU 水平的协变量。从脉冲场凝胶电泳分型中得出 Pa 分离株的辛普森多样性指数（SDI）和传播指数（TI）。

结果

在入组的 ICU 内，ICU 获得性 Pa 感染的累积发生率和发生率分别为 3.38%（55/1625）与 3.44%（57/1658）和 3.31 与 3.52 每 1000 个风险患者日。多变量模型表明，干预措施并未显著改变累积发生率（亚分布风险比，0.91；95%置信区间[CI]，0.49-1.67；P=0.76）或主要结局的发生率（病因特异性风险比，1.36；95%CI，0.71-2.63；P=0.36）。CP 和 IP 之间的 SDI 和 TI 没有显著差异。