Burden of Invasive Group B Streptococcal Disease in Infants and Resistance Surveillance in China---A National, Multi-center, Prospective Observational Study
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
- 否
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
Haiying Liu
Director of Clinical Laboratory
Guangzhou Women and Children's Medical Center
