A Study to Collect Blood and Urine Samples in Elderly Subjects With Pneumonia to Support the Development of Bacteriological Diagnostic Assays
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Detection of Streptococcus pneumoniae antigens in the urine of subjects with diagnosed pneumonia.
研究概览
简要总结
GSK Biologicals is working on the development of a vaccine to protect elderly people from bacterial pneumonia. Diagnostic of bacterial pneumonia is difficult, and for the future studies in that project, it would be useful to have some easy non invasive tests. New clinical read-outs are needed to detect and identify the causative pathogen. These assays will be based on specific antigen detection in the urine or specific pathogen DNA detection in the blood. Technical and clinical validation of these assays will be realised at later stage with samples coming from epidemiological and/or phase III studies.
To allow the development of such tests in GSK Biologicals laboratories, urine and blood samples are needed from subjects aged 65 or above who have diagnosed pneumonia.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female aged 65 or above at the time of the study.
- •Written informed consent obtained from the subject.
- •Clinical pneumonia diagnosed by chest X-ray detected within 7 days before study entry.
排除标准
- •Vaccination with a pneumococcal or Haemophilus vaccine within the last 3 months before study entry.
- •Antibiotherapy started more than 7 days before Screening.
- •A negative culture for Streptococcus pneumoniae or Non-Typable Haemophilus influenza.
- •A urine sample at Screening less than 40 mL.
结局指标
主要结局
Detection of Streptococcus pneumoniae antigens in the urine of subjects with diagnosed pneumonia.
时间窗: At the time of analysis.
Detection of Streptococcus pneumoniae DNA in the blood of subjects with diagnosed pneumonia.
时间窗: At the time of analysis.
次要结局
- Detection of Non-Typable Haemophilus influenzae antigens in the urine of subjects with diagnosed pneumonia.(At the time of analysis.)
- Detection of Non-Typable Haemophilus influenzae DNA in the blood of subjects with diagnosed pneumonia.(At the time of analysis.)