UMIN-CTR Clinical Trial

Basic information
Public title	Multi-center evaluation of novel rapid point of care diagnosis of iInfluenza virus and RS virus in Japan
Acronym	Multi-center evaluation of novel rapid point of care diagnosis of iInfluenza virus and RS virus in Japan
Scientific Title	Multi-center evaluation of novel rapid point of care diagnosis of iInfluenza virus and RS virus in Japan
Scientific Title:Acronym	Multi-center evaluation of novel rapid point of care diagnosis of iInfluenza virus and RS virus in Japan
Region	Japan

Condition
Condition	Influenza-like illness
Classification by specialty	Pneumology Infectious disease Laboratory medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the Liat Flu and RSV in the patients with influenza-like illness.
Basic objectives2	Others
Basic objectives -Others	The purpose of this study is to compare the Liat Flu and RSV with immuno-chromatography method.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Detection rate of Influenza virus and RS virus using Liat Influenza and RSV or immuno-chromatography method
Key secondary outcomes	Difference in detection rate between Liat Influenza and RSV and immuno-chromatography method Difference in diagnosis of Influenza virus infection and RS virus infection between Liat Influenza and RSV and clinical diagnosis

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients who was hospitalized or
Key exclusion criteria	a
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Katsunori Middle name Last name Yanagihara
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Laboratory Medicine
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki City, Nagasaki, Japan
TEL	095-819-7200
Email	k-yanagi@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Norihito Middle name Last name Kaku
Organization	Nagasaki University Hospital
Division name	Department of Laboratory Medicine
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki City, Nagasaki, Japan
TEL	095-819-7200
Homepage URL
Email	kaku-ngs@umin.ac.jp

Sponsor
Institute	Department of Laboratory Medicine, Nagasaki University Hospital
Institute
Department

Funding Source
Organization	Roche Diagnostics K.K.
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	Nagasaki University Hospital
Address	1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
Tel	095-819-7905
Email	gaibushikin@ml.nagasaki-u.ac.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	2020 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.jiac-j.com/article/S1341-321X(21)00018-0/fulltext
Number of participants that the trial has enrolled	182
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	2019 Year 09 Month 09 Day
Date of IRB	2019 Year 10 Month 22 Day
Anticipated trial start date	2020 Year 01 Month 01 Day
Last follow-up date	2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study

Management information
Registered date	2019 Year 09 Month 09 Day
Last modified on	2021 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043281

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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