Clinical Feature and Microbiology Characteristics of Empyema in Children

NCT ID: NCT04695275

Last Updated: 2021-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-06

Study Completion Date

2022-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Empyema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Capital Institute of Pediatrics, China

OTHER

Sponsor Role collaborator

Tianjin Children's Hospital

OTHER

Sponsor Role collaborator

Second Hospital affiliated with Tianjin Medical University

UNKNOWN

Sponsor Role collaborator

Children's Hospital of Hebei Province

OTHER

Sponsor Role collaborator

Baoding Children's Hospital

OTHER

Sponsor Role collaborator

Beijing Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Baoping XU

Director of China National Clinical Research Center for Respiratory Diseases, Chief of Respiratory Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Children's Hospital,

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Baoping Xu

Role: primary

8659616309

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BCH Lung 013

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pediatric Radio Frequency Coils Generic
NCT01633866 ACTIVE_NOT_RECRUITING