Status unknownNCT04695275Updated Jan 5, 2021

Clinical Feature and Microbiology Characteristics of Empyema in Children

An observational study in Empyema, sponsored by Beijing Children's Hospital. Status unknown at 1 site in China. Open to participants aged 1 Day to 18 Years. Per ClinicalTrials.gov, last updated 2021-01-05.

Sponsored by Beijing Children's Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Not yet recruiting — may be out of date.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 100
Ages: 1 Day to 18 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Empyema

Browse trials for

Empyema 38

Keywords

Empyema
streptococcus
Children

In context

Empyema

38 studies on the registry are indexed under Empyema; 11 are open to participants now.

Browse Empyema studies →

Lead sponsor

Beijing Children's Hospital is the lead sponsor of 52 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 1 Day to 18 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Observational model: Cohort
Time perspective: Prospective
Enrollment: 100 participants (estimated)
Patient registry: No
Biospecimen retention: Samples with dna

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Beijing Children's Hospital,
Beijing, Beijing 100045, China
- Baoping Xu · Contact · xubaopingbch@163.com · 8659616309

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2021; primary completion for Nov 2022, 22 months later.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 14, 2020
First posted: Jan 5, 2021
StartEst.: Jan 6, 2021
Primary completionEst.: Nov 30, 2022
CompletionEst.: Nov 30, 2022
Last update: Jan 5, 2021

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04695275
Lead sponsor: Beijing Children's Hospital
Collaborators: Capital Institute of Pediatrics, China, Tianjin Children's Hospital, Second Hospital affiliated with Tianjin Medical University, Children's Hospital of Hebei Province, Baoding Children's Hospital
Responsible party: Baoping XU (Director of China National Clinical Research Center for Respiratory Diseases, Chief of Respiratory Department, Beijing Children's Hospital) — Principal investigator
First posted: Jan 5, 2021
Start date: Jan 6, 2021 (estimated)
Primary completion: Nov 30, 2022 (estimated)
Completion: Nov 30, 2022 (estimated)
Last update: Jan 5, 2021

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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