A Multicenter Observational Study About the Clinical Feature and Microbiology Characteristics of Empyema in Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The improvement rate of empyema.
研究概览
简要总结
The study is designed to clarify the clinical characteristics and reversion of children with empyema, observe the effect of streptococcus vaccine application on serotype of streptococcus, and to explore the susceptibility factors of streptococcus empyema in children in China.
详细描述
Empyema is a major complication of bacterial community-acquired pneumonia in children. And studies have shown that although the incidence of community-acquired pneumonia in children has decreased with the application of pneumococcal conjugate vaccine, the incidence of empyema has increased, which raises the difficulty to disease treatment, and aggravates the financial burden on medical care.
Streptococcus is one of the most common pathogens causing children's empyema. In recent years, although more and more researches are reported on children's community- acquired pneumonia or pleural effusion, the clinical studies on streptococcus pneumoniae empyema are rarely mentioned. Therefore, a multicenter observational study is needed to better understand the clinical characteristics and reversion of children with empyema, observe the effect of streptococcus vaccine application on serotype of streptococcus, and explore the susceptibility factors of streptococcus empyema in children in China. The study mentioned above will contribute to optimize the treatment strategy of streptococcus empyema for the future, and reduce the incidence of children's empyema.
The trial will be completed in 3 years with 100 participants taken from hospitals in partnership with clinical research collaboration of National Clinical Research Center for Respiratory Diseases, China.
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 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 1 day to 18 years
- •Admitted with diagnosis of pneumonia combined with pleural effusion
- •The appearance of thoracic fluid or the results of fluid examination conforms to empyema with at least 1 of the following criteria:
- •Thoracentesis is pus.
- •Thoracic fluid smear observation show bacterial-positive.
- •Thoracic fluid culture test show bacterial-positive.
- •Cell counting of thoracic fluid is more than 10x109/L.
排除标准
- •Subjects will be excluded if the thoracic fluids are caused by non-infectious factors, such as cardiovascular, connective tissue disease, tumor or trauma, etc.
结局指标
主要结局
The improvement rate of empyema.
时间窗: 6 months
Percentage
The cure rate of empyema
时间窗: 6 months
Percentage
The incidence of long-term adverse outcomes.
时间窗: 6 months
Percentage
次要结局
- Duration of respiratory symptoms(4weeks)
- Duration of hospitalization(4weeks)
- Serotype distribution of children with streptococcus pneumoniae empyema(10 months)
- Duration of fever(4weeks)
- Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al.(4weeks)
- Proportion of streptococcus pneumoniae empyema(10 months)
- Vaccination rate of pneumococcal conjugate vaccine(6 months)
研究者
Baoping XU
Director of China National Clinical Research Center for Respiratory Diseases, Chief of Respiratory Department
Beijing Children's Hospital