UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024650 |
|---|---|
| Receipt number | R000028015 |
| Scientific Title | Epidemiological study of influenza virus infection: Household transmission of influenza infection after treatment of neuraminidase inhibitor |
| Date of disclosure of the study information | 2016/10/31 |
| Last modified on | 2019/01/30 13:36:34 |
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Basic information
Public title
Epidemiological study of influenza virus infection:
Household transmission of influenza infection after treatment of neuraminidase inhibitor
Acronym
Household transmission of influenza infection after treatment of neuraminidase inhibitor
Scientific Title
Epidemiological study of influenza virus infection:
Household transmission of influenza infection after treatment of neuraminidase inhibitor
Scientific Title:Acronym
Household transmission of influenza infection after treatment of neuraminidase inhibitor
Region
| Japan |
Condition
Condition
Influenza virus infection
Classification by specialty
| Medicine in general | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of household transmission after neuraminidase inhibitor (either Peramivir, Oseltamivir, Zanamivir, Laninamivir ) treatment based on epidemiological data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Daily secondary infection rate in household setting
Key secondary outcomes
Overall secondary infection rate in household setting
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed influenza A/B infection based on the rapid diagnosis test since 2010
Interval period for identifying 2ndary infection:24hr-7days between orignal and 2ndary infections
Key exclusion criteria
patients who showed different type or subtype of influenza virus infection compared to that of original infection
Target sample size
3400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuo Hirotsu |
Organization
Hirotsu Clinic
Division name
Internal Medicine, Pediatrics
Zip code
Address
Hisamoto 3-6-1-212, Takatsu-ku, Kawasaki-shi, Kanagawa-ken, 231-0011, Japan
TEL
044-822-1933
non-hirotsu@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuo Hirotsu |
Organization
Hirotsu Clinic
Division name
Internal Medicine, Pediatrics
Zip code
Address
Hisamoto 3-6-1-212, Takatsu-ku, Kawasaki-shi, Kanagawa-ken, 231-0011, Japan
TEL
044-822-1933
Homepage URL
non-hirotsu@umin.ac.jp
Sponsor or person
Institute
Hirotsu Clinic
Institute
Department
Personal name
Funding Source
Organization
Shionogi CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/abs/10.1111/irv.12590
Number of participants that the trial has enrolled
Results
please refer described below:
https://onlinelibrary.wiley.com/doi/abs/10.1111/irv.12590
https://rdcu.be/bfGcL
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
Main results already published
Date of protocol fixation
| 2016 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective research for influenza transmission in household setting
Management information
Registered date
| 2016 | Year | 10 | Month | 31 | Day |
Last modified on
| 2019 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028015
| Research Plan | |
|---|---|
| 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 |
