UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042878
Receipt number 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 2024/01/04 12:47:57

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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 or person

Institute

Tokyo Metropolitan Children's Medical Center

Institute

Department

Personal name



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

https://journals.lww.com/pidj/abstract/2023/12000/association_of_yersinia_infection_with_kawasaki.3.

Publication of results

Published


Result

URL related to results and publications

https://journals.lww.com/pidj/abstract/2023/12000/association_of_yersinia_infection_with_kawasaki.3.

Number of participants that the trial has enrolled

117

Results

During the study period, 141 KD patients were screened and 117 patients with evaluable stool samples were registered. Only 1 patient was positive for Yersinia pseudotuberculosis, which was detected from both stool and blood cultures. The patient was refractory to KD treatment but improved after initiation of appropriate antibiotic therapy.

Results date posted

2024 Year 01 Month 04 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The median age was 2.2 years, and more male patients than female patients were included. All the patients had a fever and elevated inflammatory markers. IVIG therapy was given to 98% of the patients, and 23% were refractory to primary IVIG therapy and received second-line treatment.

Participant flow

During the study period, 141 KD patients were enrolled. Among these, 24 patients who did not have a stool culture were excluded. A total of 117 eligible patients were included in the analysis.

Adverse events

No

Outcome measures

Number of Yersinia positive patients

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

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

2024 Year 01 Month 04 Day



Link to view the page

Value
https://center6.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