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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043000
Receipt No. R000048526
Scientific Title A study on dynamics of anti-influenza drug low susceptibility virus in household transmission
Date of disclosure of the study information 2021/01/14
Last modified on 2021/01/29

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Basic information
Public title A prospective,observational study on influenza virus infection part2:A study on dynamics of anti-influenza drug low susceptibility virus in household transmission
Acronym A study on dynamics of anti-influenza drug low susceptibility virus in household transmission
Scientific Title A study on dynamics of anti-influenza drug low susceptibility virus in household transmission
Scientific Title:Acronym A study on dynamics of anti-influenza drug low susceptibility virus in household transmission
Region
Japan

Condition
Condition Type A influenza virus infection
Classification by specialty
Medicine in general Pneumology Infectious disease
Pediatrics Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate viral dynamics of amino acid substituted virus on target protein after treatment of baloxavir marboxil or oseltamivir phosphate
Basic objectives2 Others
Basic objectives -Others major secondary objectives:
To investigate viral dynamics of variants after transmission
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes RNA ratio of variants (PA/I38X, NA/H275Y) compared to wild type in index and secondary patients when transmission occue in addition to whole virus titer
Key secondary outcomes RNA ratio of variants (PA/I38X, NA/H275Y) compared to wild type in index and secondary patients when transmission occue in addition to whole virus titer

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 For index and 2ndary infected patients,
patients infected influenza A judged by RIDT
patients obtain a written informed consent

For index patients
index patients who incured 2ndary infection in their household members

For 2ndary infected patients
2ndary infected patietns judged by influenza type/atype during 24hr - 7days after onset of infection of index patient
housemmate with index patient

Key exclusion criteria Patients had been treated with anti-influenza drug within 2weeks prior to 1st visit for current infection

Patients with SARS-CoV(+) or had been diagnosed COVID-19 for current infection
Target sample size 860

Research contact person
Name of lead principal investigator
1st name Nobuo
Middle name
Last name Hirotsu
Organization Hirotsu medical clinic
Division name internal medicine, pediatrics
Zip code 2130011
Address Hisamoto 3-6-1-212, Takatsu-ku, Kawasaki
TEL +81-44-822-1933
Email non@hirotsu.ptu.jp

Public contact
Name of contact person
1st name Yutaka
Middle name
Last name Saisho
Organization Shionogi&Co.,Ltd.
Division name Medical affairs
Zip code 530-0012
Address 12F, Hankyu Terminal Bldg.,1-4 Shibata, 1-Chome, Kita-ku, Osaka
TEL +81-6-6485-5201
Homepage URL
Email yutaka.saisho@shionogi.co.jp

Sponsor
Institute Hirotsu medical 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)

IRB Contact (For public release)
Organization still under
Address still under
Tel +81-3-5543-0196
Email shuji.nakamura@smo-msr.co.jp

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 01 Month 14 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 Open public recruiting
Date of protocol fixation
2020 Year 10 Month 30 Day
Date of IRB
2020 Year 11 Month 10 Day
Anticipated trial start date
2021 Year 01 Month 14 Day
Last follow-up date
2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Variants (PA/I38X, NA/H275YH)dynamics (RNA ratio of Wild/variant, virus titer) after infection

Management information
Registered date
2021 Year 01 Month 14 Day
Last modified on
2021 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048526

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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