UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044403 |
|---|---|
| Receipt number | 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 | 2024/01/10 18:23:55 |
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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
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
masakazu.fujiwara@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
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
N/A
Address
N/A
Tel
N/A
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
NA
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1093/cid/ciac068
Number of participants that the trial has enrolled
146676
Results
Of the 3 933 733 families in the 2018-2019 influenza season in the JMDC-DB, 146 676 were included in the analysis.
The median proportion of families with intra-familial transmission was 9.57% and 19.35% in the BXM (N = 84 672) and OTV (N = 62 004) groups, respectively. The multivariate odds ratio of 1.73 (2.5th-97.5th percentiles, 1.68-1.77) indicated a substantially higher incidence of intra-familial infections in the OTV group versus the BXM group.
Results date posted
| 2024 | Year | 01 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 02 | Month | 01 | Day |
Baseline Characteristics
See Table 1 in the published manuscript.
https://doi.org/10.1093/cid/ciac068
Participant flow
See Figure 2 in the manuscript.
https://doi.org/10.1093/cid/ciac068
Adverse events
Not reported because of DB analysis
Outcome measures
The median proportion of families with intra-familial transmission in each group and the multivariate odds ratio.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 28 | Day |
Date of IRB
| 1977 | Year | 01 | Month | 01 | Day |
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
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050720
| 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 |
