UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030193 |
|---|---|
| Receipt number | 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 17:31:44 |
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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
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
stakahas@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034489
