UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Epidemiological study of influenza virus infection: Household transmission of influenza infection after treatment of neuraminidase inhibitor
Title of the study (Brief title)	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	Nobuo Hirotsu
Organization	Hirotsu Clinic
Division name	Internal Medicine, Pediatrics
Address	Hisamoto 3-6-1-212, Takatsu-ku, Kawasaki-shi, Kanagawa-ken, 231-0011, Japan
TEL	044-822-1933
Email	non-hirotsu@umin.ac.jp

Public contact
Name of contact person	Nobuo Hirotsu
Organization	Hirotsu Clinic
Division name	Internal Medicine, Pediatrics
Address	Hisamoto 3-6-1-212, Takatsu-ku, Kawasaki-shi, Kanagawa-ken, 231-0011, Japan
TEL	044-822-1933
Homepage URL
Email	non-hirotsu@umin.ac.jp

Sponsor
Institute	Hirotsu Clinic
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 09 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://onlinelibrary.wiley.com/doi/abs/10.1111/irv.12590
Results	please refer described below: https://onlinelibrary.wiley.com/doi/abs/10.1111/irv.12590 https://rdcu.be/bfGcL
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028015