Clinical Feature and Microbiology Characteristics of Empyema in Children

Empyema Clinical Trial

Official title:

A Multicenter Observational Study About the Clinical Feature and Microbiology Characteristics of Empyema in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04695275
• Other study ID #: BCH Lung 013
• Status: Not yet recruiting
• Start date: January 6, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: March 2020
• Source: Beijing Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Empyema

Locations

Country	Name	City	State
China	Beijing Children's Hospital,	Beijing	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
Beijing Children's Hospital	Baoding Children's Hospital, Capital Institute of Pediatrics, China, Children's Hospital of Hebei Province, Second Hospital affiliated with Tianjin Medical University, Tianjin Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cure rate of empyema	Percentage	6 months
Primary	The improvement rate of empyema.	Percentage	6 months
Primary	The incidence of long-term adverse outcomes.	Percentage	6 months
Secondary	Duration of fever	Days	4weeks
Secondary	Duration of respiratory symptoms	Days	4weeks
Secondary	Duration of hospitalization	Days	4weeks
Secondary	Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al.	Number	4weeks
Secondary	Proportion of streptococcus pneumoniae empyema	Percentage	10 months
Secondary	Serotype distribution of children with streptococcus pneumoniae empyema	Percentage	10 months
Secondary	Vaccination rate of pneumococcal conjugate vaccine	Percentage	6 months