UMIN-CTR Clinical Trial

Basic information
Public title	Comparison on the prevention of severe influenza between baloxavir marboxil and neuraminidase inhibitors using health insurance claims database -2018/2019 influenza season-
Acronym	Comparison on the prevention of severe influenza between baloxavir marboxil and neuraminidase inhibitors using health insurance claims database
Scientific Title	Comparison on the prevention of severe influenza between baloxavir marboxil and neuraminidase inhibitors using health insurance claims database -2018/2019 influenza season-
Scientific Title:Acronym	Comparison on the prevention of severe influenza between baloxavir marboxil and neuraminidase inhibitors using 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 severe influenza compared with neuraminidase inhibitors in 2018/2019 influenza season. The primary comparison group is patients who were prescribed oseltamivir.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Occurrence of hospitalization
Key secondary outcomes	Occurrence of administration of antibiotics, occurrence of pneumonia, occurrence of additional administration of anti-influenza drugs

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	1 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients whose first diagnosis date for influenza (Day 1) was within the enrollment period (1 Oct 2018 - 17 Apr 2019) 2)Patients who were continuously registered in the database for at least 6 months before Day 1 3)Patients who received baloxavir marboxil, oseltamivir, zanamivir or laninamivir on Day 1
Key exclusion criteria	1)Patients who were hospitalized on Day 1 or in the last 90 days before Day 1 2)Patients who received antibiotics on Day 1 or in the last 90 days before Day 1 3)Patients who were diagnosed as pneumonia in the last 3 months before Day 1 4)Patients who died on Day 1 5)Patients who were less than 1 year old on Day 1 6)Patients who received several anti-influenza drugs on Day 1
Target sample size	130000

Research contact person
Name of lead principal investigator	1st name Masaru Middle name Last name Masaru Sawada
Organization	Shionogi & Co., Ltd.
Division name	Pharmacovigilance Department
Zip code	541-0045
Address	1-8, Doshomachi 3-Chome, Chuo-ku, Osaka 541-0045, Japan
TEL	+81-6-6209-6974
Email	masaru.sawada@shionogi.co.jp

Public contact
Name of contact person	1st name Masakazu Middle name Last name Notohara
Organization	Shionogi & Co., Ltd.
Division name	Pharmacovigilance Department
Zip code	541-0045
Address	1-8, Doshomachi 3-Chome, Chuo-ku, Osaka 541-0045, Japan
TEL	+81-6-6209-6958
Homepage URL
Email	masakazu.notohara@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	2019 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciaa1870/6044623
Number of participants that the trial has enrolled	339007
Results	please refer described below: https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciaa1870/6044623
Results date posted	2021 Year 01 Month 20 Day
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	2019 Year 09 Month 30 Day
Date of IRB	2019 Year 09 Month 30 Day
Anticipated trial start date	2019 Year 10 Month 07 Day
Last follow-up date	2020 Year 02 Month 28 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	2019 Year 09 Month 30 Day
Last modified on	2021 Year 01 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043500