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临床试验/NCT02812576
NCT02812576Unknown不适用

Burden of Invasive Group B Streptococcal Disease in Infants and Resistance Surveillance in China---A National, Multi-center, Prospective Observational Study

Health Science Center of Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
Incidence of group B streptococcal (GBS) disease

研究概览

简要总结

Data on neonatal GBS disease are very limited in China. Acceptance and implementation of prevention measures such as antibiotics prevention or vaccination against GBS disease would require robust data. This study as the first national, multicenter study to investigate the epidemiology of GBS disease in China, and the resistance surveillance of GBS isolates, to appraise the necessity of appropriate interventions.

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
— 至 90 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Positive culture for GBS from normally sterile sites such as blood or cerebrospinal fluid.
  • ≤90 days old at the time of GBS confirmation.
  • Voluntary written informed consent provided.

排除标准

  • 未提供

结局指标

主要结局

Incidence of group B streptococcal (GBS) disease

时间窗: From birth to 3 months of age

Case Fatality Rate of GBS disease

时间窗: From birth to 3 months of age

GBS serotype distribution

时间窗: From birth to 3 months of age

次要结局

未报告次要终点

研究者

发起方
Health Science Center of Xi'an Jiaotong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Haiying Liu

Director of Clinical Laboratory

Guangzhou Women and Children's Medical Center

研究点 (1)

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