UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018129 |
|---|---|
| Receipt number | R000021001 |
| Scientific Title | Confirmation of influenza virus from the patients diagnosed by rapid antigen tests |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2015/12/30 09:43:35 |
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Basic information
Public title
Confirmation of influenza virus from the patients diagnosed by rapid antigen tests
Acronym
Virus isolation and rapid antigen tests results
Scientific Title
Confirmation of influenza virus from the patients diagnosed by rapid antigen tests
Scientific Title:Acronym
Virus isolation and rapid antigen tests results
Region
| Japan |
Condition
Condition
influenza
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of influenza virion in the patients diagnosed by antigen tests.
Basic objectives2
Others
Basic objectives -Others
Same as above
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
no discrepancy between antigen test and virus isolation
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
rapid antigen positive patienst
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi SEKI |
Organization
Tohoku pharmaceutical University Hospital
Division name
Respiratory
Zip code
Address
Sendai City, Japan
TEL
022-259-1221
seki@hosp.tohoku-pharm.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi SEKI |
Organization
Tohokun pharmaceutical University
Division name
respiratory
Zip code
Address
Sendai City, Japan
TEL
022-259-1221
Homepage URL
seki@hosp.tohoku-pharm.ac.jp
Sponsor or person
Institute
Tohoku pharmeceutical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Scientic funds from Japanese goverment
Organization
Division
Category of Funding Organization
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
| 2015 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Now on going
Management information
Registered date
| 2015 | Year | 06 | Month | 30 | Day |
Last modified on
| 2015 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021001
