Contact precautions in single-bed or multiple-bed rooms for patients with extended-spectrum β-lactamase-producing Enterobacteriaceae in Dutch hospitals: a cluster-randomised, crossover, non-inferiority study
Contact precautions in single-bed or multiple-bed rooms for patients with extended-spectrum β-lactamase-producing Enterobacteriaceae in Dutch hospitals: a cluster-randomised, crossover, non-inferiority study
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DOI：
10.1016/s1473-3099(19)30262-2
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发表时间：
2019-10-01
影响因子：
56.3
通讯作者：
Kluytmans, Jan A. J. W.
中科院分区：
文献类型：
--
作者：
Kluytmans-van den Bergh, Marjolein F. Q.;Bruijning-Verhagen, Patricia C. J.;Kluytmans, Jan A. J. W.
背景使用单床室控制产超广谱β-内酰胺酶（ESBL）的肠杆菌科仍在争论中;应用接触预防措施时的附加值尚未显示。我们的目的是评估是否接触预防措施的隔离策略，在多床位的房间是非劣效于接触预防措施的策略，在一张单人床的房间，以防止传播产ESBL的Enterobacteriaceae.Methods我们做了一个集群随机，交叉，非劣效性研究的内科和外科病房的16家荷兰医院。在两个连续研究阶段，单床房间的接触预防措施或多床房间的接触预防措施作为从常规临床样本中培养出产ESBL肠杆菌科的患者（索引患者）的首选隔离策略。合格的索引患者年龄≥ 18岁，在单床病房中没有严格的屏障预防指征，在培养后7天内和出院前报告了培养结果，并且没有已知被具有相似细菌谱的相同细菌种属的产ESBL肠杆菌科分离株定植或感染的病友。通过计算机以1：1的比例将医院随机分配到两个隔离策略序列中的一个，并按大学或非大学医院分层。对评估结果的实验室技术人员进行了盲法分配，但对登记索引患者的患者、治疗医生和感染控制从业人员则未进行盲法分配。主要结局是产ESBL肠杆菌科向病友的传播，其定义为直肠携带产ESBL肠杆菌科分离株，该分离株与至少一名病友中索引患者的分离株具有克隆相关性。主要分析在符合方案人群中进行，包括遵守分配房间类型的患者。使用风险差异的10%非劣效性界值评估非劣效性。本研究在Nederlands Trialregister注册，NTR 2799。结果16家医院被随机分配，每个隔离策略序列8家。所有随机分配到序列单床房间然后多床房间的医院和随机分配到序列多床房间然后单床房间的8家医院中的5家完成了两个研究阶段并进行了分析。从2011年4月24日至2014年2月27日，对1652名索引患者和12875名病友进行了合格性评估。其中，入组了693例索引患者和9527名病友，463例索引患者和7093名病友被纳入符合方案人群。在单床病房策略期间，275例索引患者中有11例（4%）和188例索引患者中有14例（7（粗风险差异3.4%，90%CI-0.3至7.1）.解释对于从常规临床样品培养的产ESBL肠杆菌科的患者，在预防产ESBL肠杆菌科传播方面，多床病房的接触预防隔离策略不劣于单床病房的接触预防策略。多床病房策略的非劣效性可能会改变目前单床病房对产ESBL肠杆菌科患者的隔离偏好，从而拓宽日常临床实践中产ESBL肠杆菌科的感染控制选择。
Background Use of single-bed rooms for control of extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae is under debate; the added value when applying contact precautions has not been shown. We aimed to assess whether an isolation strategy of contact precautions in a multiple-bed room was non-inferior to a strategy of contact precautions in a single-bed room for preventing transmission of ESBL-producing Enterobacteriaceae.Methods We did a cluster-randomised, crossover, non-inferiority study on medical and surgical wards of 16 Dutch hospitals. During two consecutive study periods, either contact precautions in a single-bed room or contact precautions in a multiple-bed room were applied as the preferred isolation strategy for patients with ESBL-producing Enterobacteriaceae cultured from a routine clinical sample (index patients). Eligible index patients were aged 18 years or older, had no strict indication for barrier precautions in a single-bed room, had a culture result reported within 7 days of culture and before discharge, and had no wardmate known to be colonised or infected with an ESBLproducing Enterobacteriaceae isolate of the same bacterial species with a similar antibiogram. Hospitals were randomly assigned in a 1: 1 ratio by computer to one of two sequences of isolation strategies, stratified by university or non-university hospital. Allocation was masked for laboratory technicians who assessed the outcomes but not for patients, treating doctors, and infection-control practitioners enrolling index patients. The primary outcome was transmission of ESBL-producing Enterobacteriaceae to wardmates, which was defined as rectal carriage of an ESBLproducing Enterobacteriaceae isolate that was clonally related to the index patient's isolate in at least one wardmate. The primary analysis was done in the per-protocol population, which included patients who were adherent to the assigned room type. A 10% non-inferiority margin for the risk difference was used to assess non-inferiority. This study is registered with Nederlands Trialregister, NTR2799.Findings 16 hospitals were randomised, eight to each sequence of isolation strategies. All hospitals randomised to the sequence single-bed room then multiple-bed room and five of eight hospitals randomised to the sequence multiplebed room then single-bed room completed both study periods and were analysed. From April 24, 2011, to Feb 27, 2014, 1652 index patients and 12 875 wardmates were assessed for eligibility. Of those, 693 index patients and 9527 wardmates were enrolled and 463 index patients and 7093 wardmates were included in the per-protocol population. Transmission of ESBL-producing Enterobacteriaceae to at least one wardmate was identified for 11 (4%) of 275 index patients during the single-bed room strategy period and for 14 (7%) of 188 index patients during the multiple-bed room strategy period (crude risk difference 3.4%, 90% CI -0.3 to 7.1).Interpretation For patients with ESBL-producing Enterobacteriaceae cultured from a routine clinical sample, an isolation strategy of contact precautions in a multiple-bed room was non-inferior to a strategy of contact precautions in a singlebed room for preventing transmission of ESBL-producing Enterobacteriaceae. Non-inferiority of the multiple-bed room strategy might change the current single-bed room preference for isolation of patients with ESBL-producing Enterobacteriaceae and, thus, broaden infection-control options for ESBL-producing Enterobacteriaceae in daily clinical practice.