UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026546 |
|---|---|
| Receipt number | R000030438 |
| Scientific Title | A study on carriage of Neisseria meningitidis among dormitory residents |
| Date of disclosure of the study information | 2017/03/14 |
| Last modified on | 2025/04/01 17:26:52 |
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Basic information
Public title
A study on carriage of Neisseria meningitidis among dormitory residents
Acronym
A study on carriage of Neisseria meningitidis among dormitory residents
Scientific Title
A study on carriage of Neisseria meningitidis among dormitory residents
Scientific Title:Acronym
A study on carriage of Neisseria meningitidis among dormitory residents
Region
| Japan |
Condition
Condition
Carriage of Neisseria meningitidis
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate pharyngeal carriage rate of Neisseria meningitidis among dormitory residents
Basic objectives2
Others
Basic objectives -Others
To investigate characteristics of isolated N. miningitidis and relationship between carriage and social behaviors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharyngeal carriage rate of N. meningitidis
Key secondary outcomes
Characteristics of isolated N. miningitidis and relationship between carriage and social behaviors
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Dormitory residents
Key exclusion criteria
Those who had received antibiotics within one month before the study and those with acute respiratory infections
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Koki |
| Middle name | |
| Last name | Kaku |
Organization
National Defense Medical College
Division name
Division of Infectious Diseases Epidemiology and Control, National Defense Medical Research Institute
Zip code
359-8513
Address
3-2 Namiki, Tokorozawa, Saitama
TEL
04-2995-1211
kaku@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Kanayama |
Organization
National Defense Medical College
Division name
Division of Infectious Diseases Epidemiology and Control, National Defense Medical Research Institut
Zip code
359-8513
Address
3-2 Namiki, Tokorozawa, Saitama
TEL
04-2995-1211
Homepage URL
kanayama@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
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
National Defense Medical College
Address
3-2 Namiki, Tokorozawa, Saitama
Tel
04-2995-1211
ins010@ndmc.ac.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
| 2017 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
www.jstage.jst.go.jp/article/yoken/74/5/74_JJID.2020.890/_pdf/-char/en
Publication of results
Published
Result
URL related to results and publications
www.jstage.jst.go.jp/article/yoken/74/5/74_JJID.2020.890/_pdf/-char/en
Number of participants that the trial has enrolled
264
Results
The survey was conducted twice between November 2018 and January 2019 for first- to third-year students (N = 376) in a medical school dormitory. The two surveys yielded carriage rates of 0.4% (one positive among 257 students) and 2.1% (two positives among 97 students, including 90 re-participants). No transmission or persistence of a specific strain was observed during the two months.
Results date posted
| 2025 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Dormitory residents of schools
Participant flow
Dormitory residents of schools
Adverse events
None
Outcome measures
Pharyngeal carriage rate of N. meningitidis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Unpublished
Management information
Registered date
| 2017 | Year | 03 | Month | 14 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030438
