UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010032 |
|---|---|
| Receipt number | 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 19:23:57 |
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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
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
Sponsor or person
Institute
Takasaki Pediatric Clinic
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
