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
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
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
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
