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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010032
Receipt No. R000011743
Scientific Title Epidemiologic study;Efficacy study of new diagnosis kit (rapid antigen test) for influenza virus in early diagnosis. An open-label, non-randomized, multi-central study.
Date of disclosure of the study information 2013/02/14
Last modified on 2013/08/23

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Basic information
Public title Epidemiologic study;Efficacy study of new diagnosis kit (rapid antigen test) for influenza virus in early diagnosis. An open-label, non-randomized, multi-central study.
Acronym KS-BF study
Scientific Title Epidemiologic study;Efficacy study of new diagnosis kit (rapid antigen test) for influenza virus in early diagnosis. An open-label, non-randomized, multi-central study.
Scientific Title:Acronym KS-BF study
Region
Japan

Condition
Condition Influenza virus infections.
Classification by specialty
Medicine in general Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The evaluation of useful1nes of new diagnosis kit;Brightpoc(TM)-Flu for influenza virus in early diagnosis.
Basic objectives2 Others
Basic objectives -Others useful1nes
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The positive rate of Brightpoc(TM)-Flu according to duration of influenza infection.
Key secondary outcomes None.

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
1 months-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Target information.
1) Gender: Male or female. Age: over 28 days old.
2) Bellow data;
a)Duration of influenza.
b)Use Brightpoc TM-Flu for diagnosis.
c)Judgment result of Brightpoc(TM)-Flu (negative-positive, virus sub-type).
d)Virus isolation and PCR.
3) The patients with agreement.
Key exclusion criteria Non target information.
Patients who are deemed to be inappropriate by the investigator.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Takasaki
Organization Takasaki Pediatric Clinic
Division name Pediatrics
Zip code
Address 4-14-33 Shimoyamato, Nishi-ku, Fukuoka, 819-0052, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Takasaki Pediatric Clinic
Division name Pediatrics
Zip code
Address 092-891-3105
TEL
Homepage URL
Email

Sponsor
Institute Takasaki Pediatric Clinic
Institute
Department

Funding Source
Organization None.
Organization
Division
Category of Funding Organization Self funding
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 高崎小児科医院(福岡県)、しんどう小児科医院(福岡県)、横山小児科医院(福岡県)、やました小児科医院(福岡県)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 14 Day

Related information
URL releasing protocol
Publication of results 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 Completed
Date of protocol fixation
2013 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 09 Day
Last follow-up date
2013 Year 06 Month 30 Day
Date of closure to data entry
2013 Year 07 Month 31 Day
Date trial data considered complete
2013 Year 07 Month 31 Day
Date analysis concluded
2013 Year 07 Month 31 Day

Other
Other related information An open-label, non-randomized, multi-central study.

Management information
Registered date
2013 Year 02 Month 14 Day
Last modified on
2013 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011743

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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