UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015458 |
|---|---|
| Receipt number | R000017973 |
| Scientific Title | A multi-center prospective study of the usefulness of the rapid diagnosis kits and the effectiveness of neuraminidase inhibitors. |
| Date of disclosure of the study information | 2014/10/20 |
| Last modified on | 2016/04/27 13:21:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A multi-center prospective study of the usefulness of the rapid diagnosis kits and the effectiveness of neuraminidase inhibitors.
Acronym
FLU STUDY'14-'15/JPA(II)
Scientific Title
A multi-center prospective study of the usefulness of the rapid diagnosis kits and the effectiveness of neuraminidase inhibitors.
Scientific Title:Acronym
FLU STUDY'14-'15/JPA(II)
Region
| Japan |
Condition
Condition
influenza
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the sensitivity of rapid diagnostic kits by comparison with the results of virus isolation and/or PCR.
To evaluate the clinical effectiveness of antiviral drug by the time required for alleviation of fever and by the virus survival rate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy of rapid diagnostic kit.
Duration of fever after the start of treatment
Virus detection rate after treatment.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
None
Key exclusion criteria
None
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Iwaki |
Organization
Japan Physicians Association
Division name
Influenza study group
Zip code
Address
1-2-2 Hitotsubashi Chiyoda-ku, Tokyo-to, Japan
TEL
03-5224-6110
jpa@oregano.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Kawai |
Organization
Japan Physicians Association
Division name
Influenza study group
Zip code
Address
1-2-2 Hitotsubashi Chiyoda-ku, Tokyo-to, Japan
TEL
03-5224-6110
Homepage URL
jpa@oregano.ocn.ne.jp
Sponsor or person
Institute
Influenza study group, Japan Physicians Association
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www.japha.jp
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
| 2014 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 07 | Month | 20 | Day |
Other
Other related information
To evaluate the sensitivity of rapid diagnostic kits by comparison with the results of virus isolation and/or PCR.
To evaluate the clinical effectiveness of antiviral drug by the time required for alleviation of fever and by the virus survival rate
Management information
Registered date
| 2014 | Year | 10 | Month | 17 | Day |
Last modified on
| 2016 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017973
