Clinical Feature and Microbiology Characteristics of Empyema in Children

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

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.

Study Overview

• Status: Unknown
• Conditions: Empyema

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100045
      • Beijing Children's Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are aged 1day to 18 years, and diagnosed with "pneumonia combined with empyema"

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The cure rate of empyema	Percentage	6 months
The improvement rate of empyema.	Percentage	6 months
The incidence of long-term adverse outcomes.	Percentage	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of fever	Days	4weeks
Duration of respiratory symptoms	Days	4weeks
Duration of hospitalization	Days	4weeks
Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al.	Number	4weeks
Proportion of streptococcus pneumoniae empyema	Percentage	10 months
Serotype distribution of children with streptococcus pneumoniae empyema	Percentage	10 months
Vaccination rate of pneumococcal conjugate vaccine	Percentage	6 months

Collaborators and Investigators

• Sponsor: Beijing Children's Hospital
• Collaborators: Children's Hospital of Hebei Province; Tianjin Children's Hospital; Capital Institute of Pediatrics, China; Baoding Children's Hospital; Second Hospital affiliated with Tianjin Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 6, 2021
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: January 3, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 3, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Children; streptococcus; Empyema
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Empyema
• Other Study ID Numbers: BCH Lung 013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No