EmpyemaNCT04695275
Clinical Feature and Microbiology Characteristics of Empyema in Children
An observational study of Empyema, run by Beijing Children's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Empyema
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2021to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who are aged 1day to 18 years, and diagnosed with "pneumonia combined with empyema"
Who may be able to join
- 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.
Who cannot join
- Subjects will be excluded if the thoracic fluids are caused by non-infectious factors, such as cardiovascular, connective tissue disease, tumor or trauma, etc.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Children's Hospital,
Beijing, Beijing Municipality, 100045
Baoping Xu, 8659616309, xubaopingbch@163.com
About this study
Official title: 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.
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
- Empyema
- Keywords
- Empyema, streptococcus, Children
- Medical subject headings
- Empyema
What is being measured
The primary outcome is the main question the study is designed to answer.
The cure rate of empyema
Percentage
Measured: 6 months
The improvement rate of empyema.
Percentage
Measured: 6 months
The incidence of long-term adverse outcomes.
Percentage
Measured: 6 months
Secondary outcomes (7)
Duration of fever
Days
Measured: 4weeks
Duration of respiratory symptoms
Days
Measured: 4weeks
Duration of hospitalization
Days
Measured: 4weeks
Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al.
Number
Measured: 4weeks
Proportion of streptococcus pneumoniae empyema
Percentage
Measured: 10 months
Serotype distribution of children with streptococcus pneumoniae empyema
Percentage
Measured: 10 months
Vaccination rate of pneumococcal conjugate vaccine
Percentage
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start6 Jan 2021 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmpyemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Baoping XU, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695275
- Sponsor's protocol ID
- BCH Lung 013
- Status last verified
- Mar 2020
- First submitted
- 14 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Observational Study About the Clinical Feature and Microbiology Characteristics of Empyema in Children
- ClinicalTrials.gov ID
- NCT04695275
- Acronym / sponsor ID
- BCH Lung 013
- Conditions
- Empyema
- Keywords
- Empyema, streptococcus, Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- 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
- Study start
- 6 Jan 2021 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who are aged 1day to 18 years, and diagnosed with "pneumonia combined with empyema"
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (1 listed)
- Subjects will be excluded if the thoracic fluids are caused by non-infectious factors, such as cardiovascular, connective tissue disease, tumor or trauma, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The cure rate of empyema
Time frame: 6 months
Percentage
The improvement rate of empyema.
Time frame: 6 months
Percentage
The incidence of long-term adverse outcomes.
Time frame: 6 months
Percentage
7 secondary outcomes
Duration of fever
Time frame: 4weeks
Duration of respiratory symptoms
Time frame: 4weeks
Duration of hospitalization
Time frame: 4weeks
Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al.
Time frame: 4weeks
Proportion of streptococcus pneumoniae empyema
Time frame: 10 months
Serotype distribution of children with streptococcus pneumoniae empyema
Time frame: 10 months
Vaccination rate of pneumococcal conjugate vaccine
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Empyema, run by Beijing Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cure rate of empyema (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.