Clinical Feature and Microbiology Characteristics of Empyema in Children
A Multicenter Observational Study About the Clinical Feature and Microbiology Characteristics of Empyema in Children
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2020
CompletedFirst Posted
Study publicly available on registry
January 5, 2021
CompletedStudy Start
First participant enrolled
January 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedJanuary 5, 2021
March 1, 2020
1.9 years
December 14, 2020
January 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (7)
Duration of fever
4weeks
Duration of respiratory symptoms
4weeks
Duration of hospitalization
4weeks
Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al.
4weeks
Proportion of streptococcus pneumoniae empyema
10 months
- +2 more secondary outcomes
Eligibility Criteria
Patients who are aged 1day to 18 years, and diagnosed with "pneumonia combined with empyema"
You may qualify if:
- 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.
You may not qualify if:
- Subjects will be excluded if the thoracic fluids are caused by non-infectious factors, such as cardiovascular, connective tissue disease, tumor or trauma, etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Children's Hospitallead
- Capital Institute of Pediatrics, Chinacollaborator
- Tianjin Children's Hospitalcollaborator
- Second Hospital affiliated with Tianjin Medical Universitycollaborator
- Children's Hospital of Hebei Provincecollaborator
- Baoding Children's Hospitalcollaborator
Study Sites (1)
Beijing Children's Hospital,
Beijing, Beijing Municipality, 100045, China
Biospecimen
Whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of China National Clinical Research Center for Respiratory Diseases, Chief of Respiratory Department
Study Record Dates
First Submitted
December 14, 2020
First Posted
January 5, 2021
Study Start
January 6, 2021
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
January 5, 2021
Record last verified: 2020-03