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临床试验/NCT03980197
NCT03980197Unknown不适用

Strategy to Prevent Transmission of Multidrug-resistant Gram-negative Organisms in ICU - Evaluation of Effect of Active Surveillance Test

Sung-Han Kim2 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2019年6月3日最近更新:
适应症
干预措施

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

  1. 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).
  2. 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.
  3. 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

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

Experimental

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

Active Comparator

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

发起方
Sung-Han Kim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sung-Han Kim

Princiapl investigator

Asan Medical Center

研究点 (2)

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