UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030315
Receipt number R000034619
Scientific Title Evaluation for Xpert Xpress Flu/RSV to detect Influenzavirus and RSvirus
Date of disclosure of the study information 2018/01/01
Last modified on 2019/12/10 10:11:08

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Basic information

Public title

Evaluation for Xpert Xpress Flu/RSV to detect Influenzavirus and RSvirus

Acronym

Evaluation for Xpert Xpress Flu/RSV to detect Influenzavirus and RSvirus

Scientific Title

Evaluation for Xpert Xpress Flu/RSV to detect Influenzavirus and RSvirus

Scientific Title:Acronym

Evaluation for Xpert Xpress Flu/RSV to detect Influenzavirus and RSvirus

Region

Japan


Condition

Condition

suspected Influenza

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate Xpert Xpress to detect Influenzavirus and RSvirus

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Superiority of Xpert Xpress to immunochromatography test kit

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

1 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

suspected Influenza

Key exclusion criteria

none

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Satoshi
Middle name
Last name Takahashi

Organization

Sapporo Medical University

Division name

Department of Infection Control and Laboratory Medicine

Zip code

0608543

Address

S1, W16, Chuo-ku, Sapporo

TEL

0116112111

Email

stakahas@sapmed.ac.jp


Public contact

Name of contact person

1st name Satoshi
Middle name
Last name Takahashi

Organization

Sapporo Medical University

Division name

Department of Infection Control and Laboratory Medicine

Zip code

0608543

Address

S1, W16, Chuo-ku, Sapporo

TEL

0116112111

Homepage URL


Email

stakahas@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University

Institute

Department

Personal name



Funding Source

Organization

Sapporo Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Sapporo Medical University Hospital

Address

S1, W16, Chuo-ku, Sapporo

Tel

011-611-2111

Email

stakahas@sapmed.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

2018 Year 01 Month 01 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

2018 Year 01 Month 01 Day

Date of IRB

2017 Year 11 Month 09 Day

Anticipated trial start date

2018 Year 01 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To compare the results of two test kits


Management information

Registered date

2017 Year 12 Month 08 Day

Last modified on

2019 Year 12 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034619


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name