UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039883 |
|---|---|
| Receipt number | R000045478 |
| Scientific Title | Study on the carriage rate of Neisseria meningitidis in healthy university students living in dormitories |
| Date of disclosure of the study information | 2020/03/19 |
| Last modified on | 2025/03/24 10:10:56 |
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Basic information
Public title
Study on the carriage rate of Neisseria meningitidis in healthy university students living in dormitories
Acronym
Study on the carriage rate of Neisseria meningitidis in healthy university students living in dormitories
Scientific Title
Study on the carriage rate of Neisseria meningitidis in healthy university students living in dormitories
Scientific Title:Acronym
Study on the carriage rate of Neisseria meningitidis in healthy university students living in dormitories
Region
| Japan |
Condition
Condition
meningococcal infections
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japan, the severe infection caused by Neisseria meningitidis is rare, but an epidemic outbreak infrequently occurs in places such as dormitories. It is known that the bacteria exist in membranes in the throat of healthy people but the actual situation of the carriage is not fully known. With being a carrier of N. meningitidis for some periods, the carrier acquires immunity to the bacteria and becomes less likely to suffer from severe meningococcal disease. However, persons who recently exposed to a certain type of N. meningitides (highly virulent species) are more likely to have a risk of causing the infection.
This study is conducted to analyze the carriage rate among boarding and non-boarding students in Mie University and to use the results to establish preventive measures against meningococcal infections.
Basic objectives2
Others
Basic objectives -Others
To elucidate the carriage rate of pharyngeal meningococci among Japanese and international students living in Japanese university dormitories.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To elucidate the carriage rate of pharyngeal meningococci among Japanese and international students living in Japanese university dormitories.
Key secondary outcomes
To elucidate the risk factors (including the residential form such as university dormitories and homes) of meningococcal carriage in Japanese university students.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Targets of cross-sectional carrier rate survey
Japanese boarding students: 233
Foreign boarding students: 209
Non-boarding Japanese students: approx. 200
2.Targets of Long-term survey subjects
Japanese boarding students: 128
Foreign boarding students: 185
Non-boarding Japanese students: approx. 150
Key exclusion criteria
1.Those who have received meningococcal vaccine in the past
2.Patients who received antibiotics within the past two weeks from the sample collection date
3.Those who have used immunosuppressants or steroids within the past two weeks from the date of sample collection
4.Patients with immunodeficiency, blood disease or other chronic diseases
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Hori |
Organization
Mie University Graduate School of Medicine
Division name
Medical Education
Zip code
514-8507
Address
1577, Kurimamachiyacho, Tsu, Mie, Japan
TEL
059-231-6003(ext.6412)
hhori@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Hori |
Organization
Mie University Graduate School of Medicine
Division name
Medical Education
Zip code
514-8507
Address
1577, Kurimamachiyacho, Tsu, Mie, Japan
TEL
059-231-6003(ext.6412)
Homepage URL
hhori@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sanofi Pasteur S.A.
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
France
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie University Hospital
Address
2-174, Edobashi, Tsu, Mie, Japan
Tel
059-231-5246
N/A
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
三重大学大学院医学系研究科(三重県)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 19 | 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
944
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
Relevant factors to consider and outcomes:
The following studies are carried out.
1.Cross-sectional study on the carriage rate of Neisseria meningitidis in healthy university students living in dormitories
2.Three months longitudinal study on carriage rate of Neisseria meningitidis in healthy freshmen entering dormitories
These studies are conducted to analyze the carriage rate among boarding and non-boarding students in Mie University and to use the results to establish preventive measures against meningococcal infections.
Basic design:
non-randomized prospective cohort study
Management information
Registered date
| 2020 | Year | 03 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045478
