Clinical Feature and Microbiology Characteristics of Empyema in Children
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Duration of fever [4weeks]
Days
- Duration of respiratory symptoms [4weeks]
Days
- Duration of hospitalization [4weeks]
Days
- 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
- Serotype distribution of children with streptococcus pneumoniae empyema [10 months]
Percentage
- Vaccination rate of pneumococcal conjugate vaccine [6 months]
Percentage
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age between 1 day to 18 years
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Admitted with diagnosis of pneumonia combined with pleural effusion
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The appearance of thoracic fluid or the results of fluid examination conforms to empyema with at least 1 of the following criteria:
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Thoracentesis is pus.
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Thoracic fluid smear observation show bacterial-positive.
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Thoracic fluid culture test show bacterial-positive.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Children's Hospital, | Beijing | Beijing | China | 100045 |
Sponsors and Collaborators
- Beijing Children's Hospital
- 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
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BCH Lung 013