Mastering Hospital Antibiotic Resistance, a Cluster Randomized Intervention Study in Intensive Care Units Throughout Europe (Work Package 3)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 14,318
- 试验地点
- 26
- 主要终点
- Colonization with MRSA, VRE and ESBL
研究概览
简要总结
Colonization of patients with Antimicrobial Resistant Bacteria (AMRB) like Methicillin Resistant Staphylococcus Aureus (MRSA), Vancomycin-Resistant Enterococcus (VRE) and Extended-Spectrum Beta-Lactamases (ESBL) enterobacteriaceae leads to infections; and ultimately to adverse outcomes (eg prolonged hospital stay, death). This is an urgent problem in Europe, especially in Intensive Care Units (ICUs).
In this trial, colonization of patients with these AMRB will be assessed in the baseline period (6m). In phase 2 the effect of a Hygiene Improvement Program, including Chlorhexidine body washings and a Hand Hygiene training program, will be assessed (6m). In phase 3 units will be randomized to either Active Surveillance with Chromagar based tests or a Molecular based tests.
Study Hypothesis: the abovementioned interventions will reduce ICU-acquired colonization rates with MRSA, VRE and ESBL.
详细描述
A cluster-randomized trial with a stepped wedge design will be conducted in adult ICU's throughout Europe
The MOSAR-ICU trial is motivated by three primary considerations:
- Advances in behavioral sciences and research about (hand) hygiene compliance have allowed a better understanding of barriers to increase compliance with (hand) hygiene practices within healthcare institutions;
- Recent investigations have identified new rapid tests, both chromogenic media and molecular based tests, which may help identifying previously unknown carriage of AMRB at the time of admission; and
- Currently practiced procedures, such as regular surveillance of all patients and daily cleansing of ICU patients with Chlorhexidine, have not been evaluated properly for their effectiveness.
In conclusion, evidence base derived recommendations from prospective studies regarding the costeffectiveness of different control strategies are lacking.
This study assess the impact of the three interventions on ICU acquired colonisation rates for AMRB(MRSA,VRE and ESBL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •colonization with either MRSA, VRE or ESBL is endemic
- •at least one dedicated infection control physician
- •ability to obtain, store and analyze surveillance cultures
- •at least 8 ICU beds; all of which have possibility for mechanical ventilation
- •ability to collect the data required for analysis
- •written approval of the institution's IRB
- •signed protocol signature page
排除标准
- •burn units
- •cardiothoracic units
- •pediatric and neonatal ICUs
- •ICU is currently using rapid diagnostic testing in their screening program for AMRB
- •ICU is planning to enroll subjects in studies testing investigational agents for the purpose of eradicating or preventing colonization with MRSA, VRE or ESBL or devices or practice management strategies that have colonization and/or infection with AMRB as an outcome
- •using SOD/ SDD or any topical antimicrobial therapy
- •using chlorhexidine body washings
结局指标
主要结局
Colonization with MRSA, VRE and ESBL
时间窗: During ICU stay
By taking surveillance swabs twice weekly from nose, perineum and wounds (if present) we will assess whether patients become colonized with MRSA, VRE and ESBL during ICU stay. Swabs will be processed on chromogenic agars. Note: for patients admitted for longer than 21 days, surveillance is reduced to once weekly.
次要结局
- Incidence density of new acquisitions with MRSA, VRE and ESBL individually.(Acquired during ICU stay (median LOS 14 days))
- ICU-acquired bacteremia rates with MRSA,VRE or ESBL.(Acquired during ICU stay (median LOS 14 days))
- 28 day-mortality(28 days)