UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037969
Receipt number R000043281
Scientific Title Multi-center evaluation of novel rapid point of care diagnosis of iInfluenza virus and RS virus in Japan
Date of disclosure of the study information 2020/01/01
Last modified on 2021/02/15 11:24:21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Department of Laboratory Medicine, Nagasaki University Hospital

Institute

Department

Personal name



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

Value
https://center6.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