NCT01931800已完成不适用
Identification and Quantification of Immune Response Induced by Hyaluronidase and Other Factors of Virulence of Invasive Human Infections of Streptococcus Pneumoniae
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Quantification of immune response induced by the hyaluronidase of Streptococcus pneumoniae
研究概览
简要总结
- 4 tubes (2 x7-ml dry tubes with yellow gelose, and 2 x 5 ml tubes with blue CTAD) will be taken from the patient within 24 hours following inclusion (D0) in the department in which the patient is hospitalised
- 4 tubes (2 x7-ml dry tubes with yellow gelose, and 2 x 5 ml tubes with blue CTAD) will be taken from the patient every 7 days following inclusion for 5 weeks (if the patient is still in hospital at the time), in the department where he/she is hospitalised (D7, D14, D21, D28, D35). Samples will no longer be taken once the patient has left the CHU, even if all of the samples have not been taken.
- For children less than 6 years old, only 2 tubes (1 x 7 ml dry tube with yellow gelose, and 1x5 ml tube with blue CTAD) will be taken following the same timetable.
- For hospitalised patients, a leeway of 48 hours is authorized for the sampling procedure. Samples will be taken at the same time samples are taken for the usual care of the patient.
- The tubes will be taken to the Bacteriology Laboratory using the usual collection circuit of the CHU. These tubes will then be redirected to the Infectious Diseases Laboratory to be centrifuged and then stored at -80°C. The strain of Streptococcus pneumoniae isolated in the patient will be preserved at -80°C. If strains other than Streptococcus pneumoniae are isolated, these different strains will all be preserved at -80°C under the same identification number.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (children or adults) hospitalised at Dijon CHU
- •Presenting invasive pneumococcal disease, confirmed by:
- •The presence of Streptococcus pneumoniae in a blood culture, or The presence of Streptococcus pneumoniae in a sample of cerebrospinal fluid, or The presence of significant levels of Streptococcus pneumoniae in an endobronchial sample (bronchial brushing or bronchoalveolar lavage), or in protected tracheal aspirations or in the spit of non-hospitalised patients or those in Intensive care Units.
排除标准
- •Patients in whom the implication of Streptococcus pneumoniae is suspected because of: positive urinary soluble antigen of Streptococcus pneumoniae with the exclusion of any other positive sample, presence of non- significant levels of Streptococcus pneumoniae in bronchopulmonary samples The presence of significant levels of Streptococcus pneumoniae in protected tracheal aspirations or in the spit, with the exclusion of any other positive sample in patients who had been in an Intensive care Unit for more than 48 hours at the time the sample was taken.
- •Patients in whom Streptococcus pneumoniae had already been isolated in the 5 weeks preceding inclusion in the present study.
结局指标
主要结局
Quantification of immune response induced by the hyaluronidase of Streptococcus pneumoniae
时间窗: In the visit of inclusion then every 7 days during all the duration of patient hospitalization
次要结局
- Quantification of hyaluronidase expression in strains of Streptococcus pneumoniae(In the visit of inclusion then every 7 days during all the duration of his hospitalization)
研究者
研究点 (1)
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