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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042945
Receipt No. R000049012
Scientific Title Influenza viral shedding after treatment with and anti-influenza drug
Date of disclosure of the study information 2021/01/08
Last modified on 2021/01/08

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Basic information
Public title Influenza viral shedding after treatment with and anti-influenza drug
Acronym Influenza viral shedding after treatment with and anti-influenza drug
Scientific Title Influenza viral shedding after treatment with and anti-influenza drug
Scientific Title:Acronym Influenza viral shedding after treatment with and anti-influenza drug
Region
Japan

Condition
Condition Influenza
Classification by specialty
Medicine in general Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate viral persistence after treatment with an anti-influenza drug
Basic objectives2 Others
Basic objectives -Others To investigate viral persistence after treatment with an anti-influenza drug
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Virus detection rate by virus culture at day 5 and/or day 10 after treatment with an anti-influenza drug
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 Patients diagnosed as influenza with a rapid antigen detection kit
Key exclusion criteria None
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Mochizuki
Organization Japan Physicians Association
Division name None
Zip code 101-0062
Address 2-5 Tokyo Medeical Association Bld. Kandasurugadai, Chiyoda-ku, Tokyo 101-0062
TEL 03-3259-6111
Email jpa@nichirinnai.jp

Public contact
Name of contact person
1st name Chigusa
Middle name
Last name Iwasaki
Organization RICERCA CLINICA Co.,Ltd
Division name Clinical support center
Zip code 812-0013
Address 2-18-30 Yaesuhakata Bld.6F, Hakataeki Higashi, Hakata-ku, Fukuoka-shi, Fukuoka, 812-0013
TEL 092-435-1150
Homepage URL
Email secretary@ricercaclinica.jp

Sponsor
Institute Japan Physicians Association Influenza Study Group
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 Haradoi Hospital
Address 6-40-8, Aoba, Higashi-ku, Fukuoka-shi, Fukuo ka 813-8588
Tel 0120-372-891
Email irb@haradoi-hospital.com

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 08 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 Enrolling by invitation
Date of protocol fixation
2020 Year 09 Month 04 Day
Date of IRB
2020 Year 10 Month 06 Day
Anticipated trial start date
2021 Year 01 Month 06 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Influenza viral shedding after treatment with and anti-influenza drug

Management information
Registered date
2021 Year 01 Month 08 Day
Last modified on
2021 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049012

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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