UMIN-CTR Clinical Trial

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
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 treatme nt 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	200

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 12 Month 06 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	Completed
Date of protocol fixation	2021 Year 09 Month 03 Day
Date of IRB	2021 Year 10 Month 19 Day
Anticipated trial start date	2021 Year 12 Month 13 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	Influenza viral shedding after treatment with and anti-influenza drug

Management information
Registered date	2021 Year 11 Month 30 Day
Last modified on	2022 Year 05 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052762