UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043226 |
|---|---|
| Receipt number | R000049327 |
| Scientific Title | Nationwide surveillance of bacterial pathogens isolated from children conducted by the surveillance committee of Japanese Society of Chemotherapy, the Japanese Association for Infectious Diseases, and the Japanese Society for Clinical Microbiology in 2021 |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2026/02/06 09:35:08 |
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Basic information
Public title
Nationwide surveillance of bacterial pathogens isolated from children conducted by the surveillance committee of Japanese Society of Chemotherapy, the Japanese Association for Infectious Diseases, and the Japanese Society for Clinical Microbiology in 2021
Acronym
Nationwide surveillance of bacterial pathogens isolated from children
Scientific Title
Nationwide surveillance of bacterial pathogens isolated from children conducted by the surveillance committee of Japanese Society of Chemotherapy, the Japanese Association for Infectious Diseases, and the Japanese Society for Clinical Microbiology in 2021
Scientific Title:Acronym
Nationwide surveillance of bacterial pathogens isolated from children
Region
| Japan |
Condition
Condition
Respiratory tract infection
Classification by specialty
| Infectious disease | Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to analyze the antimicrobial susceptibilities of bacterial pathogens isolated from pediatric patient with respiratory tract infection though nationwide surveillance.
Basic objectives2
Others
Basic objectives -Others
Serotype distribution of H. influenzae and S. pneumoniae
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Antimicrobial susceptibility of Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarhalis and Bordetella pertussis isolated from respiratory tract infection in children.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
H. influenzae, S. pneumoniae, M. catarrhalis and B. pertussis isolated from respiratory tract infection in children
Key exclusion criteria
None
Target sample size
1000
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
260-8673
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, Chiba-shi, Chiba-ken, Japan
TEL
0432262799
Homepage URL
ishiwada@faculty.chiba-u.jp
Sponsor or person
Institute
Japanese Society of Chemotherapy, the Japanese Association for Infectious Diseases, and the Japanese Society for Clinical Microbiology
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Chemotherapy, the Japanese Association for Infectious Diseases, and the Japanese Society for Clinical Microbiology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University
Address
1-8-1, Inohana, Chuo-ku Chiba-shi, Chiba-ken, Japan
Tel
0432262462
inohana-shien@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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
doi: 10.1016/j.jiac.2025.102812
Publication of results
Published
Result
URL related to results and publications
doi: 10.1016/j.jiac.2025.102812
Number of participants that the trial has enrolled
1498
Results
Among 384 S. pneumoniae isolates, vaccine serotype coverage was 4.4% for the 13-valent pneumococcal conjugate vaccine. Among 530 H. influenzae isolates, 9.2 % were beta-lactamase-producing and 35.3 % were beta-lactamase-non-producing ampicillin-resistant (BLNAR) strains. All 584 M. catarrhalis isolates were beta-lactamase-producing strains, and one macrolide-resistant strain was identified for the first time in our surveillance program.
Results date posted
| 2026 | Year | 02 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Pediatric patients with respiratory tract infections
Participant flow
Bacteria isolated from Pediatric patients with respiratory tract infections
Adverse events
None
Outcome measures
These findings underscore the ongoing shifts in antimicrobial resistance and serotype distribution and provide information that will inform future treatment and prevention strategies.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 02 | Month | 02 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049327
