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

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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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name