UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047513 |
|---|---|
| Receipt number | R000054186 |
| Scientific Title | pneumococcal carriage study using saliva samples from children and adults in Japan |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2023/05/17 14:30:02 |
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Basic information
Public title
pneumococcal carriage study using saliva samples from children and adults in Japan
Acronym
pneumococcal carriage study using saliva samples
Scientific Title
pneumococcal carriage study using saliva samples from children and adults in Japan
Scientific Title:Acronym
pneumococcal carriage study using saliva samples
Region
| Japan |
Condition
Condition
Healthy Japanese children and adults
Classification by specialty
| Infectious disease | Pediatrics | Laboratory medicine |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objectives are to clarify the yearly change of pneumococcus carriage status and serotype distribution in the Japanese population and compare the pneumococcal carriage status and dominant serotypes between two young adult cohorts healthy individuals.
Basic objectives2
Others
Basic objectives -Others
The secondary objective is to clarify the risk-factors of pneumococcal carriage among Japanese people.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the carriage rate in the Japanese population according to various age groups.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy people
Key exclusion criteria
individuals without respiratory symptoms
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Naruhiko |
| Middle name | Chiba |
| Last name | Ishiwada |
Organization
Medical Mycology Research Center, Chiba University
Division name
Department of Infectious Diseases
Zip code
2608673
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
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
2608673
Address
1-8-1 Inohana Chuoku Chibashi Chiba Japan
TEL
0432262799
Homepage URL
ishiwada@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Merck Co Inc
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
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
アリス耳鼻咽喉科(千葉県）・あんどうクリニック（千葉県）・牛久愛和総合病院小児科（茨城県）・かるがもクリニック（東京都）・マーガレットこどもクリニック（東京都）・有秋台医院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 01 | 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
| 2022 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | 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
| 2022 | Year | 04 | Month | 18 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054186
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
