UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022325 |
|---|---|
| Receipt number | R000024991 |
| Scientific Title | The Epidemiological study on the incidence of childhood community acquired pneumonia and bacteriologically confirmed pneumococcal pneumonia in Chiba city, Japan |
| Date of disclosure of the study information | 2016/05/16 |
| Last modified on | 2020/05/19 12:44:12 |
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Basic information
Public title
The Epidemiological study on the incidence of childhood community acquired pneumonia and bacteriologically confirmed pneumococcal pneumonia in Chiba city, Japan
Acronym
The Epidemiological study on the incidence of childhood community acquired pneumonia in Chiba city, Japan
Scientific Title
The Epidemiological study on the incidence of childhood community acquired pneumonia and bacteriologically confirmed pneumococcal pneumonia in Chiba city, Japan
Scientific Title:Acronym
The Epidemiological study on the incidence of childhood community acquired pneumonia in Chiba city, Japan
Region
| Japan |
Condition
Condition
pneumonia
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to clarify the epidemiologic and microbiologic picture of community acquired pneumonia in children after the introduction of pneumococcal conjugate vaccine in Japan.
Basic objectives2
Others
Basic objectives -Others
The aim of the study is to clarify the epidemiologic and microbiologic picture of pneumococcal pneumonia pneumonia in children after the introduction of 13 valent pneumococcal conjugate vaccine in Japan.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate the incidence of CAP after the introduction of PCV13 in Chiba city, Japan
Key secondary outcomes
To reveal the incidence of bacteriologically confirmed PP in children after the introduction of PCV13
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 4 | weeks-old | <= |
Age-upper limit
| 192 | weeks-old | > |
Gender
Male and Female
Key inclusion criteria
pediatric inpatient with community acquired pneumonia who residents in Chiba city
Key exclusion criteria
none
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Naruhiko |
| Middle name | |
| Last name | Ishiwada |
Organization
Medical Mycology Research Center, Chiba University
Division name
Department of Infectious Diseases
Zip code
260-8673
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
0432262799
ishiwada@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Naruhiko |
| Middle name | |
| Last name | Ishiwada |
Organization
Medical Mycology Research Center, Chiba University
Division name
Department of Infectious Diseases
Zip code
260-8673
Address
1-8-1 Inohana Chuo ku Chibashi
TEL
0432262799
Homepage URL
ishiwada@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Infectious Diseases, Medical Mycology Research Center, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Pfizer Japan Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Mycology Research Center
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi
Tel
0432262799
ishiwada@faculty.chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部附属病院 千葉県こども病院 千葉市立海浜病院 千葉メディカルセンター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 16 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/32299523
Publication of results
Partially published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/32299523
Number of participants that the trial has enrolled
1399
Results
The CAP hospitalisation rate per 1000 child-years was 17.7, 14.3 and 9.7 in children aged <5 years and 1.18, 2.64 and 0.69 in children aged 5-15 years in 2008, 2012 and 2018, respectively. There was a 45% and 41% reduction in CAP hospitalisation rates, between the pre-PCV7 and PCV13 periods, respectively. Significant reductions occurred in the proportion of CAP due to PP and PCV13 serotypes. Conversely, no change occurred in the proportion of CAP caused by H. influenzae.
Results date posted
| 2020 | Year | 05 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This observational hospital-based surveillance study included children aged equal and less than 15 years, admitted to hospitals in and around Chiba City, Japan.
Participant flow
Participants had bacterial pneumonia based on a positive blood or sputum culture for bacterial pathogens. Serotype and antibiotic-susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae isolates from patients with bacterial pneumonia were assessed.
Adverse events
None
Outcome measures
The incidence of hospitalized CAP in children
The rate of bacterial pneumonia
serotype and antimicrobial susceptibility of S. pneumoniae and H. influenzaeisolated from pediatric CAP
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 31 | Day |
Other
Other related information
observational population-based cohort study
Target population
All children living in Chiba city who were
admitted to hospitals during the study period(April, 2016-March, 2019)
Management information
Registered date
| 2016 | Year | 05 | Month | 16 | Day |
Last modified on
| 2020 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024991
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
