Clinical Feature and Microbiology Characteristics of Empyema in Children

• Conditions: Empyema

• Registration Number: NCT04695275
• Lead Sponsor: Beijing Children's Hospital

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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2021-01-03
• Last Update Submitted: 2021-01-03
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-05
• Study Start: 2021-01-06
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The improvement rate of empyema.	6 months	Percentage
The incidence of long-term adverse outcomes.	6 months	Percentage
The cure rate of empyema	6 months	Percentage

Secondary Outcome Measures

Name	Time	Method
Duration of respiratory symptoms	4weeks	Days
Duration of hospitalization	4weeks	Days
Serotype distribution of children with streptococcus pneumoniae empyema	10 months	Percentage
Duration of fever	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
Vaccination rate of pneumococcal conjugate vaccine	6 months	Percentage

Trial Locations

Locations (1)

Beijing Children's Hospital,; 🇨🇳 Beijing, Beijing, China