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临床试验/NCT04647630
NCT04647630招募中不适用

Prospective Study to Evaluate Streptococcus Pneumoniae Serotypes Prevalence in Community Acquired Pneumonia in Hong Kong Using a Urinary Kit

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2021年1月1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
1,800
试验地点
1
主要终点
Determine the prevalence of pneumococcal serotypes in adults hospitalized

研究概览

简要总结

This is an epidemiology study for the prevalence and serotypes of pneumococcus pneumoniae in hospitalized patients with community acquired pneumonia (CAP). The serotypes of the pneumococcus pneumoniae will be determined by a urinary antigen assay. This is a single center, non-interventional observatory study.

详细描述

Patients admitted to the medical wards with a provisional diagnosis under "pneumonia","chest infection" or "fever" will be screened by research assistants.

Patients eligible with the inclusion criteria will be recruited into the study. Informed consent will be signed for those patients willing to participate in the study. Patient will be asked to save approximately 40 ml of urine. The urine sample will be processed in local laboratory and shipped out to a commercial lab for detection of any pneumococcal pneumoniae, and if present, serotyping will be performed at the same time using the same urine sample by urinary antigen assay. Meanwhile patients will be managed as usual by their clinical teams. Investigations and treatment will be offered by the clinical team as deemed necessary. The study team will only perform collection of urine and will not interfere the clinical management of the patients.

Positive results would be informed to the clinical teams for the appropriate action.

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

入选标准

  • Admitted with signs and symptoms suggestive of pneumonia

排除标准

  • Nosocomial pneumonia which is acquired >= 48 hours after hospital admission.
  • Pneumonia which are already known to be caused by pathogens other than pneumococcus pneumoniae.

结局指标

主要结局

Determine the prevalence of pneumococcal serotypes in adults hospitalized

时间窗: 2 years

Determine the prevalence of pneumococcal serotypes in adults hospitalized with pneumococcal community acquired pneumonia (CAP) using a specific urine antigen assay

次要结局

未报告次要终点

研究者

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

To Kin Wang

Honoary Clinical Associate Professor

Chinese University of Hong Kong

研究点 (1)

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