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临床试验/NCT05282082
NCT05282082已完成不适用

A Smart Surveillance Strategy for Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.

Erasmus Medical Center3 个研究点 分布在 3 个国家目标入组 2,105 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,105
试验地点
3
主要终点
Prevalence of CRPA carriage in healthy individuals and newly hospitalized patients, CRPA prevalence in wet hospital environments, CRPA concentrations in aquatic environments, and the frequency and transmission likelihood within epidemiological clusters

研究概览

简要总结

Pseudomonas aeruginosa causes severe infections in hospitalized patients. The worldwide emergence of carbapenem-resistant P. aeruginosa (CRPA) makes infections by these pathogens almost untreatable. The World Health Organization now ranks CRPA highest in the list of 'urgent threats'. Information for action to prevent further emergence has to come from insight into sources and transmission routes through smart surveillance. At present, a smart surveillance strategy is not available for CRPA. The aim of this project is to develop a globally-applicable smart surveillance strategy to guide action against the spread of CRPA. Since P. aeruginosa prefers moist niches, we will focus on the human-water interface. First, highly-sensitive methods to detect CRPA in specific environmental and human niches will be developed. Subsequently, CRPA will be collected in three study sites with increasing prevalences of CRPA, increasingly warmer climates, and different water situations: Rotterdam (The Netherlands), Rome (Italy), Jakarta (Indonesia). CRPA will be searched for in a variety of niches in the environment outside and inside the hospital, and in healthy humans and hospitalized patients. Whole genome sequencing will be performed to compare the CRPA from different sources and identify transmission routes. Our project will provide insight into the relative contribution of the different potential reservoirs of CRPA to its spread in different settings which will be used for the development of a globally-applicable surveillance strategy for CRPA to guide preventive actions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • healthy individuals:
  • All healthy individuals (i.e., not hospitalized) aged 18 years or older and living in a "high-risk area" in Rotterdam, Rome or Jakarta.

排除标准

  • healthy individuals:
  • No signed consent sheet.
  • Inclusion Criteria patients:
  • Must be aged 18 years or older;
  • Should be capable of providing answers to the questions in the questionnaire by himself/herself;
  • Should have a minimum expected length of stay of at least 24 hours;
  • Inclusion only once during the sampling year.
  • Exclusion Criteria patients:
  • Cystic fibrosis patients
  • No signed consent sheet.

研究组 & 干预措施

Patients at the moment of their admission to the hospital in one of the three cities

Swabs will be taken from patients who are willing to participate.

Healthy volunteers living in "high-risk areas" in one of the three cities.

Swabs will be taken from healthy volunteers who are willing to participate.

结局指标

主要结局

Prevalence of CRPA carriage in healthy individuals and newly hospitalized patients, CRPA prevalence in wet hospital environments, CRPA concentrations in aquatic environments, and the frequency and transmission likelihood within epidemiological clusters

时间窗: 2022/2024

次要结局

  • Prevalence of body site-specific CRPA carriage in healthy individuals and newly hospitalized patients, prevalence of clinical CRPA isolates, and prevalence and geographic distribution of carbapenemase genes.(2022/2024)

研究者

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

Juliëtte Severin

Associate professor, Medical coordinator Unit infection prevention

Erasmus Medical Center

研究点 (3)

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