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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044403
Receipt No. R000050720
Scientific Title Comparison of household transmission of influenza virus from index patients treated with baloxavir marboxil or oseltamivir using influenza transmission model and health insurance claims database -2018/2019 influenza season-
Date of disclosure of the study information 2021/06/04
Last modified on 2021/06/02

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Basic information
Public title Comparison of household transmission of influenza virus from index patients treated with baloxavir marboxil or oseltamivir using influenza transmission model and health insurance claims database
-2018/2019 influenza season-
Acronym Comparison of household transmission of influenza virus from index patients treated with baloxavir marboxil or oseltamivir using influenza transmission model and health insurance claims database
Scientific Title Comparison of household transmission of influenza virus from index patients treated with baloxavir marboxil or oseltamivir using influenza transmission model and health insurance claims database
-2018/2019 influenza season-
Scientific Title:Acronym Comparison of household transmission of influenza virus from index patients treated with baloxavir marboxil or oseltamivir using influenza transmission model and health insurance claims database
Region
Japan

Condition
Condition Influenza virus infection
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the preventive effect of baloxavir marboxil on household influenza infection compared with oseltamivir in 2018/2019 influenza season using influenza transmission model.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Occurrence of household influenza infection
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Families which had an IC (index case; the first patient diagnosed as influenza in each family) during the enrollment period (1 Oct 2018 - 23 Apr 2019)
2)Families whose IC was an outpatient
3)Families whose IC received baloxavir marboxil, oseltamivir on Day 1 (the first date when an IC was diagnosed as influenza).
Key exclusion criteria 1) Families in which no family member was identified other than the IC
2) Families which had two or more ICs
3) Families whose IC was hospitalized after outpatient diagnosis
4) Families whose IC received several anti-influenza drugs
Target sample size 120000

Research contact person
Name of lead principal investigator
1st name Yoshitake
Middle name
Last name Kitanishi
Organization Shionogi & Co., Ltd.
Division name Data Science Office
Zip code 5410045
Address 1-8, Doshomachi 3-Chome, Chuo-ku, Osaka 541-0045, Japan
TEL +81-6-6209-7372
Email yoshitake.kitanishi@shionogi.co.jp

Public contact
Name of contact person
1st name Masakazu
Middle name
Last name Fujiwara
Organization Shionogi & Co., Ltd.
Division name Data Science Office
Zip code 5410045
Address 1-8, Doshomachi 3-Chome, Chuo-ku, Osaka 541-0045, Japan
TEL +81-6-6209-7372
Homepage URL
Email masakazu.fujiwara@shionogi.co.jp

Sponsor
Institute Shionogi & Co., Ltd.
Institute
Department

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 N/A
Address N/A
Tel N/A
Email 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

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 04 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 Preinitiation
Date of protocol fixation
2021 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date
2021 Year 06 Month 07 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information N/A

Management information
Registered date
2021 Year 06 Month 02 Day
Last modified on
2021 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050720

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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