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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011314
Receipt No. 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

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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
Institute National Center for Global Health and Medicine
Institute
Department

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
URL(English) https://upload.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


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