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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034545
Receipt No. 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 2019/09/09

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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
Email 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
Email kaku-ngs@umin.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

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
Email 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 No longer recruiting
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

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
2019 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039384

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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