Empyema
Conditions
Keywords
Empyema, streptococcus, Children
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Capital Institute of Pediatrics, China
Tianjin Children's Hospital
Second Hospital affiliated with Tianjin Medical University
Children's Hospital of Hebei Province
Baoding Children's Hospital
Beijing Children's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Subjects will be excluded if the thoracic fluids are caused by non-infectious factors, such as cardiovascular, connective tissue disease, tumor or trauma, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The cure rate of empyema | 6 months | Percentage |
| The improvement rate of empyema. | 6 months | Percentage |
| The incidence of long-term adverse outcomes. | 6 months | Percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al. | 4weeks | Number |
| Proportion of streptococcus pneumoniae empyema | 10 months | Percentage |
| Duration of fever | 4weeks | Days |
| Vaccination rate of pneumococcal conjugate vaccine | 6 months | Percentage |
| Serotype distribution of children with streptococcus pneumoniae empyema | 10 months | Percentage |
| Duration of respiratory symptoms | 4weeks | Days |
| Duration of hospitalization | 4weeks | Days |
Countries
China
Outcome results
None listed