UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000022325
Receipt No. 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 (Ver. 10)

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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
Email 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
Email ishiwada@faculty.chiba-u.jp

Sponsor
Institute Department of Infectious Diseases, Medical Mycology Research Center, Chiba University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024991