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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042878
Receipt No. R000048940
Scientific Title Investigation of Association between Kawasaki Disease and Yersinia Infection
Date of disclosure of the study information 2021/01/01
Last modified on 2021/02/08

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Basic information
Public title Investigation of Association between Kawasaki Disease and Yersinia Infection
Acronym KD-Yersinia study
Scientific Title Investigation of Association between Kawasaki Disease and Yersinia Infection
Scientific Title:Acronym KD-Yersinia study
Region
Japan

Condition
Condition Kawasaki disease
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To discover the clinical characteristics of Yersinia infection manifesting Kawasaki disease-like symptoms
Basic objectives2 Others
Basic objectives -Others Epidemiology
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of Yersinia infection among patients diagnosed with Kawasaki disease
Key secondary outcomes The difference in the following characteristics between Yersinia positive patients and negative patients: duration of fever, unresponsiveness to IVIG, coronary artery lesion within 2 months from the beginning of treatment

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 Patients diagnosed with Kawasaki disease
Subjects who agreed, or whose parents provided consent for enrollment in the study
Key exclusion criteria Subjects without stool sample
Patients considered inappropriate for enrollment by investigator
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Hayashi
Organization Tokyo Metropolitan Children's Medical Center
Division name Department of General Pediatrics
Zip code 183-8561
Address 2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL (+81)-42-300-5111
Email hiroshi_hayashi@tmhp.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Hayashi
Organization Tokyo Metropolitan Children's Medical Center
Division name Department of General Pediatrics
Zip code 183-8561
Address 2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL (+81)-42-300-5111
Homepage URL
Email hiroshi_hayashi@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Metropolitan Children's Medical Center Clinical Research Review Board
Address 2-8-29 Musashidai, Fuchu, Tokyo, Japan
Tel (+81) -42-300-5111
Email sn_rinri@tmhp.jp

Secondary IDs
Secondary IDs YES
Study ID_1 2020b-123
Org. issuing International ID_1 Tokyo Metropolitan Children's Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京都立小児総合医療センター(東京都)/ Tokyo Metropolitan Children's Medical Center (Tokyo)

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 01 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 Open public recruiting
Date of protocol fixation
2020 Year 12 Month 01 Day
Date of IRB
2020 Year 12 Month 14 Day
Anticipated trial start date
2021 Year 01 Month 08 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The difference in the following characteristics between Yersinia positive patients and negative patients: duration of fever, unresponsiveness to IVIG, coronary artery lesion within 2 months from the beginning of treatment.

Management information
Registered date
2020 Year 12 Month 30 Day
Last modified on
2021 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048940

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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