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Efficacy Study of Rapid Test to Prevent Hospital Transmission of Methicillin-Resistant Staphylococcus Aureus (MRSA)

2010年6月14日 更新者：Erasme University Hospital

Two-Center Intervention Study to Evaluate the Impact of Rapid Molecular Screening on Nosocomial Transmission of Methicillin-Resistant Staphylococcus Aureus (MRSA).

The purpose of this study is to evaluate the efficacy of a novel PCR-based laboratory test for rapid detection of MRSA carriers to prevent transmission of MRSA in the Belgian acute care hospital setting.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Methicillin-resistant Staphylococcus aureus (MRSA) strains have become endemic pathogens in acute and chronic healthcare facilities in Belgium. MRSA infection is causing increased public concern as it carries a significant risk of morbidity, mortality and has been linked to substantial excess healthcare costs.

Efficient control of MRSA transmission within healthcare facilities critically depends on screening for and isolation of MRSA carriers among admitted patients. Active surveillance cultures for MRSA are now part of clinical practice recommendations both in Europe and the USA. Indeed, studies have indicated that up to 70 % of the patient reservoir for MRSA among hospitalized patients can only be detected by active sampling of muco-cutaneous colonization sites. There is an urgent public health need for early and reliable detection of carriers of MRSA among patients admitted to healthcare facilities, to inform patient isolation and decontamination procedures, and thereby more effectively control cross-infection

The general objectives of this intervention study to be conducted in two large Belgian hospitals are to measure the impact of rapid (< 3 h) PCR detection of MRSA carriage upon patient admission on shortening the delay to implement contact isolation precautions for carriers and reducing nosocomial MRSA transmission to patients admitted in the same wards.

研究类型

介入性

注册 (预期的)

7400

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 比利时
      • Brugge、比利时、B-8000
        • Algemeen Ziekenhuis Sint-Jan AV
      • Brussels、比利时、B-1070
        • ULB Hôpital Erasme

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • All patients admitted for more than 48h to a ward in which evaluation in the previous baseline period met the following:

    • > 80 % compliance with admission and discharge conventional culture screening, for the pooled admissions to all study wards;
    • > 80 % compliance with additional MRSA contact isolation procedures, based on a sample of 50 patient care contact observations per hospital in all study wards;
    • pooled incidence of nosocomial MRSA acquisition ≥ 1.5 new cases /100 at risk admissions in the study wards.

Exclusion Criteria:

  • Patients staying 48h or less in the study wards

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Rapid PCR screen
Rapid PCR screen test for detection of MRSA carriers upon hospital admission
其他：Rapid MRSA PCR test for screening carriers
In the rapid test intervention arm, all patients admitted to study wards will be sampled within 24 h after admission. To ensure comparison of like with like, sample taking will include: (1) a swab from the anterior nares for PCR testing according to the test manufacturer's instructions; (2) the swab of anterior nares, and swabs from throat, perineum and of any wounds, bladder catheter or intravenous catheter exit site will be processed by conventional testing.
其他名称：
  • GeneXpert MRSA, Cepheid.
  • Real-time PCR assay for MRSA
有源比较器：Conventional culture
Conventional culture screen for detection of MRSA carriers upon hospital admission
其他：Rapid MRSA PCR test for screening carriers
In the rapid test intervention arm, all patients admitted to study wards will be sampled within 24 h after admission. To ensure comparison of like with like, sample taking will include: (1) a swab from the anterior nares for PCR testing according to the test manufacturer's instructions; (2) the swab of anterior nares, and swabs from throat, perineum and of any wounds, bladder catheter or intravenous catheter exit site will be processed by conventional testing.
其他名称：
  • GeneXpert MRSA, Cepheid.
  • Real-time PCR assay for MRSA

研究衡量的是什么？

主要结果指标

结果测量
大体时间
To determine if a ≥ 50 % reduction of incidence of nosocomial MRSA acquisition can be observed after replacing culture by PCR for universal MRSA screening of patients upon admission to high incidence units in two acute care hospitals
大体时间：5-10 months
5-10 months

次要结果测量

结果测量
大体时间
Median time required for detection of MRSA carriage after admission
大体时间：5-10 months
5-10 months
Median time required for starting isolation of MRSA carriers
大体时间：5-10 months
5-10 months
Number of patient-days of MRSA carrier stay in non-isolated conditions
大体时间：5-10 months
5-10 months
MRSA nosocomial infection rate
大体时间：5-10 months
5-10 months
MRSA cross-transmission rate
大体时间：5-10 months
5-10 months
Sensitivity and specificity of PCR vs conventional MRSA screening by culture
大体时间：10 months
10 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Erasme University Hospital

调查人员

  • 首席研究员：Marc J Struelens, MD, PhD、Erasme University Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年2月1日

初级完成 (实际的)

2010年2月1日

研究完成 (实际的)

2010年5月1日

研究注册日期

首次提交

2009年2月17日

首先提交符合 QC 标准的

2009年2月17日

首次发布 (估计)

2009年2月18日

研究记录更新

最后更新发布 (估计)

2010年6月15日

上次提交的符合 QC 标准的更新

2010年6月14日

最后验证

2010年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • Erasme-ULB-P2008/201

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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