UMIN-CTR Clinical Trial

Basic information
Public title	Prospective Study on Efficacy of Acute Treatment in a Multicenter Cohort of Children with Kawasaki Disease
Acronym	PEACOCK
Scientific Title	Prospective Study on Efficacy of Acute Treatment in a Multicenter Cohort of Children with Kawasaki Disease
Scientific Title:Acronym	PEACOCK
Region	Japan

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

Objectives
Narrative objectives1	To verify the efficacy and safety of treatment of acute Kawasaki disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of coronary artery lesions at month 1 after stating initial treatment
Key secondary outcomes	incidence of additional rescue 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 as Kawasaki disease according to the Japanese diagnostic criteria for Kawasaki disease
Key exclusion criteria	patients who were treated at other hospitals and then transferred to our study group hospitals
Target sample size	1500

Research contact person
Name of lead principal investigator	1st name Masaru Middle name Last name Miura
Organization	Tokyo metropolitan children's medical center
Division name	cardiology
Zip code	1838561
Address	2-8-29 Musashidai, Fuchu city, Tokyo, Japan
TEL	042-300-5111
Email	masaru10miura@gmail.com

Public contact
Name of contact person	1st name Masaru Middle name Last name Miura
Organization	Tokyo metropolitan children's medical center
Division name	cardiology
Zip code	1838561
Address	2-8-29 Musashidai, Fuchu city, Tokyo, Japan
TEL	042-300-5111
Homepage URL	http://www.byouin.metro.tokyo.jp/shouni/tiken/rinshou_shounin.html
Email	masaru10miura@gmail.com

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

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

IRB Contact (For public release)
Organization	Tokyo Metropolitan Children's Medical Center
Address	2-8-29 Musashidai, Fuchu city, Tokyo, Japan
Tel	042-300-5111
Email	sn_rinri@tmhp.jp

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	東京都立小児総合医療センター / Tokyo metropolitan children's medical center

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 21 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	2016 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date	2016 Year 10 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	nothing particular

Management information
Registered date	2016 Year 11 Month 21 Day
Last modified on	2020 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028690