UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of a minimally invasive, ultra-sensitive rapid diagnosis kit for influenza virus
Title of the study (Brief title)	Development of rapid diagnosis kit for influenza virus
Region	Japan

Condition
Condition	Influenza virus infection
Classification by specialty	Infectious disease Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate the influenza virus amount in various specimens at onset
Basic objectives2	Others
Basic objectives -Others	To clarify the relationship between influenza virus amount before onset and onset
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Influenza virus amount at onset
Key secondary outcomes	Influenza virus amount before onset

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 who have fever up and/ or respiratory illness, and their families.
Key exclusion criteria	none
Target sample size	400

Research contact person
Name of lead principal investigator	Kazuhito Tabata
Organization	School of Engineering, The University of Tokyo
Division name	Noji Laboratory
Address	6A09, Faculty of Engineering Building 3, Hongo 7-3-1, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5841-7252
Email	kazuhito@nojilab.t.u-tokyo.ac.jp

Public contact
Name of contact person	Kazuhito Tabata
Organization	School of Engineering, The University of Tokyo
Division name	Noji laboratory
Address	6A09, Faculty of Engineering Building 3, Hongo 7-3-1, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5841-7252
Homepage URL
Email	kazuhito@nojilab.t.u-tokyo.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Non profit foundation
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	2019 Year 02 Month 08 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 02 Month 08 Day
Anticipated trial start date	2019 Year 02 Month 08 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	Unpublished
URL releasing results
Results
Other related information	Multicenter study. For patients with fever or respiratory symptoms and their families, samples are taken from nasal cavities and pharynx, and the amount of virus is measured. By investigating the amount of virus in various specimens and the progress of symptoms of the subjects, relationships between symptoms and the amount of virus are clarified.

Management information
Registered date	2019 Year 02 Month 03 Day
Last modified on	2019 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040682

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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