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临床试验/NCT05303662
NCT05303662已完成不适用

Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an Endoscopic Retrograde Cholangiopancreatography in Four Different Countries

Marco J. Bruno4 个研究点 分布在 4 个国家目标入组 1,244 人开始时间: 2022年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,244
试验地点
4
主要终点
Prevalence of multidrug resistant micro-organism carriage in patients undergoing an ERCP in four different countries

研究概览

简要总结

The duodenoscopes currently used for Endoscopic Retrograde Cholangio - and Pancreaticography (ERCP) examinations are reusable and are therefore washed and disinfected after each use. Despite this, these endoscopes sometimes remain contaminated with bacteria. Several reports of outbreaks linked to contaminated duodenoscopes have been published worldwide. Recently, the Food and Drug Administration (FDA) advised manufacturers and health care professionals to transition away from fixed endcap duodenoscopes and instead focus more on the use of duodenoscopes with disposable components or fully disposable duodenoscopes. Single-use endoscopes have been developed, but they are not yet widely used, partly because of the extra costs that these endoscopes add to the examination. A possible interim solution, is to only use these disposable endoscopes in patients who carry multi-resistant bacteria in order to prevent the spread of these bacteria. For this, it is important to know how many people who undergo an ERCP carry multi-resistant bacteria. The primary objective of this study is to measure the prevalence of multi-resistant bacteria in patients undergoing ERCP in four different countries: India, the Netherlands, Italy and the United States. In the Netherlands, some secondary outcomes will be investigated with regard to the prevalence of duodenoscope contamination, the risk of bacterial transmission via a contaminated duodenoscope and the presence of multi-resistant bacteria in the duodenum.

研究设计

研究类型
Observational
观察模型
Case Only
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
否

入选标准

  • •The subject is planned to undergo an ERCP procedure, either through an outpatient department or an inpatient department
  • •The subject is capable to understand the information required to give informed consent

排除标准

  • •In case the inclusion criteria were not met

结局指标

主要结局

Prevalence of multidrug resistant micro-organism carriage in patients undergoing an ERCP in four different countries

时间窗: 1 week

Prevalence (as a percentage) of Methicillin-resistant Staphylococcus aureus (MRSA) in nasal or throat swabs, along with rectal carriage rates of Extended Spectrum Beta-Lactamase (ESBL), Vancomycin-resistant Enterococci (VRE), Carbapenem-resistant Enterobacterales (CRE), Carbapenemase-Producing Pseudomonas aeruginosa (CPP), and resistant Acinetobacter among ERCP patients in India, the Netherlands, Italy, and the United States.

次要结局

  • Prevalence of multidrug resistant micro-organism carriage in the duodenum of patients undergoing ERCP compared to the rectum(1 week)
  • Differences of duodenal microbiome between ERCP patients carrying MDRO compared to patients without MDRO(1 week)
  • Differences of rectal microbiome between ERCP patients carrying MDRO compared to patients without MDRO(1 week)
  • Prevalence of duodenoscope-associated infections and colonizations(6 months)

研究者

发起方
Marco J. Bruno
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marco J. Bruno

Professor of Gastroenterology and Hepatology

Erasmus Medical Center

研究点 (4)

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