跳至主要内容
临床试验/NCT03794453
NCT03794453招募中不适用

Longitudinal Changes in Intestinal Microbiota and Its Association With Acquisition of Antimicrobial Resistance in a Cohort of Stroke Patients

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年8月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Proportion of patients acquiring intestinal colonization of resistant organisms

研究概览

简要总结

Antimicrobial resistance is regarded as one of the major global public health threats, causing at least 700,000 deaths per year. It has been estimated that if the current problem of antimicrobial resistance is not effectively tackled, it would cause the death of 10 million people worldwide by 2050. Multi-drug resistant pathogen is the single most important contributing factor for inappropriate antibiotics therapy, and this in turn lead to higher mortality in patients with sepsis. The slow pace of development of new classes of antimicrobial agents limits the availability of effective therapy for multi-drug resistant organisms, both currently and in the near future. It is therefore of utmost importance to look for strategies to reduce the spread and burden of antimicrobial resistance.

Intestinal microbiota probably played a dominant role in determining the risk of acquisition of multi-drug resistant organisms. For instance, findings from a mouse model showed that Barnesiella species conferred resistance to intestinal colonization by vancomycinresistant Enterococcus. Such findings were subsequently confirmed in human subjects.

This is a prospective longitudinal observational study evaluating the correlation between changes in intestinal microbiota and acquisition of antimicrobial resistance in patients hospitalized for stroke.

Adult patients admitted to the Medical unit of the Prince of Wales Hospital with a diagnosis of acute stroke will be screened for eligibility and will be invited to participate in this study. Data collected from this study will determine the correlation between antibiotics use and changes in intestinal microbiota in a cohort of hospitalized patients as well as the correlation between intestinal microbiota and acquisition of intestinal colonization or infection caused by resistant pathogens.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years or above, and
  • Radiological evidence of acute ischaemic or hemorrhagic stroke
  • Within two days of hospital admission

排除标准

  • Use of antibiotics within 4 weeks prior to the time of screening
  • Underlying gastrointestinal diseases, including gastrointestinal malignancy, inflammatory bowel disease, resection of small or large bowel
  • Pregnancy

结局指标

主要结局

Proportion of patients acquiring intestinal colonization of resistant organisms

时间窗: 2 years

Intestinal colonization of resistant organisms are defined as the presence of ESBL or resistance to one or more carbapenems in Enterobacteriaceae identified in the stool samples, in patients without these organisms detected in their stool samples at the time of admission to hospital.

次要结局

  • Proportion of patients acquiring nosocomial infections secondary to multi-drug resistant pathogens.(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Grace Lui

Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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