UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034545 |
|---|---|
| Receipt number | R000039384 |
| Scientific Title | Utility of rapid diagnositc test in the patients with influenza by using mouth washing |
| Date of disclosure of the study information | 2018/10/17 |
| Last modified on | 2020/03/18 14:22:43 |
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Basic information
Public title
Utility of rapid diagnositc test in the patients with influenza by using mouth washing
Acronym
Utility of rapid diagnositc test in the patients with influenza by using mouth washing
Scientific Title
Utility of rapid diagnositc test in the patients with influenza by using mouth washing
Scientific Title:Acronym
Utility of rapid diagnositc test in the patients with influenza by using mouth washing
Region
| Japan |
Condition
Condition
Influenza
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of utility of novel raid diagnostic test for influenza using mouth washing
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We calculated sensitivity, specificity, ROC curve, and AUC of novel rapid diagnostic test for influenza, and compared with antigen test and RT-PCR.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient who have the symptom of influenza
2. >= 15 years old
Key exclusion criteria
Patient who was administered anti-influenza agents within one month.
Target sample size
100
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 Laboratry Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
TEL
095-819-7574
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
095-819-7574
Homepage URL
kaku-ngs@umin.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Tosoh Corporation
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
Tel
095-819-7905
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
| 2018 | Year | 10 | Month | 17 | 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
100
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
| 2018 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
The results of rapid diagnostic test do not report to the physicians.
Management information
Registered date
| 2018 | Year | 10 | Month | 17 | Day |
Last modified on
| 2020 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039384
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
