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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030193
Receipt No. R000034489
Scientific Title Evaluation for Xpert Xpress Flu/RSV
Date of disclosure of the study information 2018/01/01
Last modified on 2017/11/30

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Basic information
Public title Evaluation for Xpert Xpress Flu/RSV
Acronym Evaluation for Xpert Xpress Flu/RSV
Scientific Title Evaluation for Xpert Xpress Flu/RSV
Scientific Title:Acronym Evaluation for Xpert Xpress Flu/RSV
Region
Japan

Condition
Condition Patients with suspected Influenza
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the test kit, "Xpert Xpress Flu/RSV"
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the sensitivity of detection of influenza virus compared with the test kit using immunochromatography
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 with suspected Influenza
Key exclusion criteria Patients who were already treated for Influenza
Patients who were unfit by doctor in charge
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Takahashi
Organization Sapporo Medical University
Division name School of Medicine, Department of Infection Control and Laboratory Medicine
Zip code
Address S1, W16, Chuo-ku, Sapporo
TEL 011-611-2111
Email stakahas@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Takahashi
Organization Sapporo Medical University
Division name School of Medicine, Department of Infection Control and Laboratory Medicine
Zip code
Address S1, W16, Chuo-ku, Sapporo
TEL 011-611-2111
Homepage URL
Email stakahas@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University Hospital
Institute
Department

Funding Source
Organization Sapporo Medical University Hospital
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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2017 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2017 Year 11 Month 30 Day
Last modified on
2017 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034489

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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