Strategy to Prevent Transmission of Multidrug-resistant Gram-negative Organisms in ICU - Evaluation of Effect of Active Surveillance Test
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,500
- 试验地点
- 2
- 主要终点
- The number of patients who acquired MDRGNB in ICU per 1000 patient-days
研究概览
简要总结
- Objective of study The purpose of this study was to investigate whether the active surveillance and preemptive isolation of multidrug-resistant Gram-negative bacteria in the intensive care unit affected the reduction of the rate of acquisition of multidrug- resistant Gram-negative bacteria (MDRGNB).
- Background Treatment option for MDRGNB (Carbapenem-resistant P. aeruginosa, Carbapenem-resistant A. baumannii, Carbapenem-resistant Enterobacteriaceae) is limited. Development of infection due to MDRGNB is common in ICU. Strategy to prevent transmission of MDRGNB is needed, and there is two approaches; First, antimicrobial stewardship program, and second, infection control strategy.The investigators aimed to figure out the role of active surveillance test and preemptive isolation of MDRGNB in reduction of acquisition rate of MDRGNB.
- Methods Pragmatic cluster randomized, crossover, controlled trial During first period (6 months), intervention group (randomized 3 ICUs) perform daily chlorhexidine bathing, active surveillance test and preemptive isolation and contact precaution. Control group (randomized 3 ICUs) perform standard precaution with daily chlorhexidine bathing, and start contact precaution when clinical isolates reveals MDRGNB.
After 1 month washout period, intervention group and control group cross over for next 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Enroll all patients who admit to the ICUs during the study period
排除标准
- •Patients who discharge within 2 days after admission to ICUs
研究组 & 干预措施
Intervention
Active surveillance test and preemptive isolation is performed. If MDRO is isolated in surveillance test, contact precaution is needed.
干预措施: Active surveillance and preemptive isolation (Other)
Control
No active surveillance test and preemptive isolation performed. Only standard precaution is needed, and if clinical isolates reveals MDRO, start contact precaution.
干预措施: Control (Other)
结局指标
主要结局
The number of patients who acquired MDRGNB in ICU per 1000 patient-days
时间窗: through study completion, an average 6 months
The number of patients who acquired MDRGNB in ICU per 1000 patient-days
次要结局
- Rate of bloodstream infection due to MDRGNB(through study completion, an average 6 months)
- Hand hygiene compliance rates (%) of healthcare workers(through study completion, an average 1 year)
- Days of ICU stay(through study completion, an average 6 months)
- 28-day mortality rate(28-days)
研究者
Sung-Han Kim
Princiapl investigator
Asan Medical Center
