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临床试验/CTRI/2022/08/045131
CTRI/2022/08/045131尚未招募不适用

Carbapenem Resistant Enterobacterales Surveillance in Two Intensive CareUnits in India (CRESCENT Study)

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年1月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
试验地点
1
主要终点
Estimates of admission CRE prevalence and CRE acquisition rates in the study ICUs using SCS.

研究概览

简要总结

Enterobacterales are a group of different types of bacteria among which some bacteria can cause serious and deadly infections in healthcare settings. When Enterobacterales develop resistance to an important group of antibiotics called carbapenems, they are called carbapenem-resistant Enterobacterales (CRE). CRE are a major concern for patients in healthcare settings because they are resistant to carbapenem antibiotics, which are considered the last line of defense to treat multidrug-resistant bacterial infections. Due to high levels of antibiotic resistance in CRE in a number of regions and healthcare settings, treatment options are often limited to more toxic and less effective antibiotics and thus, CRE infections are associated with high mortality worldwide. Barriers in healthcare access, diagnostic testing, and therapeutic options experienced by low- and middle-income countries (LMICs) make them more vulnerable to adverse outcomes from CRE infections. India is a LMIC where CRE is highly prevalent in healthcare facilities. In 2019 national surveillance data from 21 Indian hospitals noted that 35% of Enterobacterales isolated from clinical specimens (excluding urine and feces) were carbapenem resistant. Despite this high burden of CRE, studies examining CRE prevalence on admission and subsequent acquisition in hospitals in India are extremely limited. An important aspect of developing surveillance systems for CRE colonization within a hospital is having actionable data to prevent the spread of infection to other vulnerable patients. However, cost-effective methods for CRE surveillance in resource-limited settings has been identified as a major gap. Active surveillance which involves admission and weekly cultures for intestinal CRE colonization (presence of bacteria in the digestive tract without causing disease) among hospitalized patients is the preferred method to monitor CRE transmission. However, this method is highly resource intensive, making it impractical in LMICs. The World Health Organization (WHO) recognizes that the cost of CRE surveillance is a major barrier toward implementing their guidance to prevent carbapenem resistant bacterial infections in health care facilities.

In this study we will examine the utility and feasibility of a low intensity (less resource intensive) active CRE surveillance strategy to guide infection prevention practices in two intensive care units (ICUs) in a tertiary care hospital in India.

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Consenting patients admitted to selected ICUs.

排除标准

  • 未提供

结局指标

主要结局

Estimates of admission CRE prevalence and CRE acquisition rates in the study ICUs using SCS.

时间窗: At 24-48 hours of ICU admission, every week, at ICU discharge or death or until colonized with CRE

次要结局

  • 2.Risk factors associated with CRE colonization on admission and CRE acquisition during ICU stay.(3.Estimates of CRE prevalence detected by routine clinical cultures versus surveillance cultures.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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