UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058710 |
|---|---|
| Receipt number | R000067127 |
| Scientific Title | ationwide surveillance of Bordetella pertussis 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 and the Japanese Society for Infection Prevention and Control |
| Date of disclosure of the study information | 2025/08/06 |
| Last modified on | 2025/08/06 12:19:47 |
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Basic information
Public title
Nationwide surveillance of Bordetella pertussis 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 and the Japanese Society for Infection Prevention and Control
Acronym
Nationwide surveillance of pertussis isolated from children
Scientific Title
ationwide surveillance of Bordetella pertussis 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 and the Japanese Society for Infection Prevention and Control
Scientific Title:Acronym
Nationwide surveillance of pertussis isolated from children
Region
| Japan |
Condition
Condition
Pertussis
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the susceptibility of Bordetella pertussis isolated from pediatric patients with pertussis to various antimicrobial agents and clarify the drug resistance status.
Basic objectives2
Others
Basic objectives -Others
Macrolide resistance status of Bordetella pertussis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Antimicrobial susceptibility of Bordetella pertussis isolated from pertussis 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
patient with pertussis
Key exclusion criteria
None
Target sample size
100
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, Chiba-shi, Chiba
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 and Japanese Society for Infection Prevention and Control
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Chemotherapy, the Japanese Association for Infectious Diseases, and the Japanese Society for Clinical Microbiology and Japanese Society for Infection Prevention and Control
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Mycology Research Center, Chiba University
Address
1-8-1, Inohana Chuo-ku, Chiba-shi, Chiba
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
千葉県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nationwide Surveillance
Management information
Registered date
| 2025 | Year | 08 | Month | 06 | Day |
Last modified on
| 2025 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067127
