UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011314
Receipt number R000009323
Scientific Title Clinical evaluation of three rapid immunochromatographic tests for the diagnosis of dengue virus infection
Date of disclosure of the study information 2013/07/30
Last modified on 2018/06/19 10:59:19

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Basic information

Public title

Clinical evaluation of three rapid immunochromatographic tests for the diagnosis of dengue virus infection

Acronym

Clinical evaluation of rapid tests for dengue

Scientific Title

Clinical evaluation of three rapid immunochromatographic tests for the diagnosis of dengue virus infection

Scientific Title:Acronym

Clinical evaluation of rapid tests for dengue

Region

Japan


Condition

Condition

Dengue fever

Classification by specialty

Infectious disease Laboratory medicine Adult
Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of rapid tests for dengue in travelers at Japanese clinical settings

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Sensitivity and specificity compared with the gold standards (PCR and ELISA)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

evaluate three rapid tests by using whole blood

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

acute febrile illness

Key exclusion criteria

48 hours passed after fever resolution
fever sustains over 10 days

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuyuki Kato

Organization

National Center for Global Health and Medicine

Division name

Division of Preparedness and Emerging Infections, Disease Control and Prevention Center

Zip code


Address

1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan

TEL

03-3202-7181

Email

ykato@hosp.ncgm.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasuyuki Kato

Organization

National Center for Global Health and Medicine

Division name

Division of Preparedness and Emerging Infections, Disease Control and Prevention Center

Zip code


Address

1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan

TEL

03-3202-7181

Homepage URL


Email

ykato@hosp.ncgm.go.jp


Sponsor or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour, and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

National Institute of Infectious Diseases

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

国立国際医療研究センター病院(東京都)、がん・感染症センター都立駒込病院(東京都)、都立墨東病院(東京都)


Other administrative information

Date of disclosure of the study information

2013 Year 07 Month 30 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


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

2012 Year 05 Month 31 Day

Date of IRB


Anticipated trial start date

2012 Year 06 Month 29 Day

Last follow-up date

2014 Year 03 Month 31 Day

Date of closure to data entry

2015 Year 03 Month 31 Day

Date trial data considered complete

2015 Year 03 Month 31 Day

Date analysis concluded

2017 Year 11 Month 15 Day


Other

Other related information



Management information

Registered date

2013 Year 07 Month 30 Day

Last modified on

2018 Year 06 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009323


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name