UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000062821
Receipt number R000071862
Scientific Title A Real-World Survey of Clostridioides difficile Infection in Pediatric Patients
Date of disclosure of the study information 2026/09/04
Last modified on 2026/09/04 13:53:01

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Basic information

Public title

A Real-World Survey of Clostridioides difficile Infection in Pediatric Patients

Acronym

Survey of Clostridioides difficile Infection in Pediatric Patients

Scientific Title

A Real-World Survey of Clostridioides difficile Infection in Pediatric Patients

Scientific Title:Acronym

A Real-World Survey of Clostridioides difficile Infection in Pediatric Patients

Region

Japan


Condition

Condition

Clostridioides difficile Infection

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the current clinical practices for the diagnosis and management of Clostridioides difficile infection in pediatric patients in Japan.

Basic objectives2

Others

Basic objectives -Others

To conduct a survey on the current clinical practices for the diagnosis and management of Clostridioides difficile infection in pediatric patients in Japan.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

A web-based survey on the current clinical practices for the diagnosis and management of Clostridioides difficile infection in pediatric patients in Japan.

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

Individuals engaged in pediatric clinical practice who indicated their willingness to participate in and provide responses to this questionnaire survey.

Key exclusion criteria

NA

Target sample size

6600


Research contact person

Name of lead principal investigator

1st name Yuka
Middle name
Last name Yamagishi

Organization

Kochi University

Division name

Department of Clinical Infectious Diseases, Kochi Medical School

Zip code

783-8505

Address

185-1, Kohasu, Oko-cho, Nankoku City, Kochi

TEL

0888665811

Email

yyamagishi@kochi-u.ac.jp


Public contact

Name of contact person

1st name Yuka
Middle name None
Last name Yamagishi

Organization

Kochi University

Division name

Department of Clinical Infectious Diseases, Kochi Medical School

Zip code

783-8505

Address

185-1, Kohasu, Oko-cho, Nankoku City, Kochi

TEL

0888665811

Homepage URL

https://www.kochi-u.ac.jp/kms/courses/57/clostridioidesdifficile.html

Email

yyamagishi@kochi-u.ac.jp


Sponsor or person

Institute

Kochi University

Institute

Department

Personal name



Funding Source

Organization

AstraZeneca KK

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical Review Board of Kochi Medical School

Address

185-1, Kohasu, Oko-cho, Nankoku City, Kochi

Tel

088-880-2180

Email

is21@kochi-u.ac.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



Other administrative information

Date of disclosure of the study information

2026 Year 09 Month 04 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

2026 Year 03 Month 31 Day

Date of IRB

2026 Year 03 Month 31 Day

Anticipated trial start date

2026 Year 06 Month 01 Day

Last follow-up date

2026 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

NA


Management information

Registered date

2026 Year 09 Month 04 Day

Last modified on

2026 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071862