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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037165
Receipt No. R000042348
Scientific Title shiga toxin producing escherichia coli Infection, antibiotics, and risk of developing hemolytic uremic syndrome, a case control study
Date of disclosure of the study information 2019/06/28
Last modified on 2019/06/25

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Basic information
Public title shiga toxin producing escherichia coli Infection,
antibiotics, and risk of developing hemolytic uremic syndrome, a case control study
Acronym shiga toxin producing escherichia coli Infection,
antibiotics, and risk of developing hemolytic uremic syndrome, a case control study
Scientific Title shiga toxin producing escherichia coli Infection,
antibiotics, and risk of developing hemolytic uremic syndrome, a case control study
Scientific Title:Acronym shiga toxin producing escherichia coli Infection,
antibiotics, and risk of developing hemolytic uremic syndrome, a case control study
Region
Japan

Condition
Condition hemolytic uremic syndrome
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To quantify the risk of developing hemolytic uremic syndrome associated with antibiotic administration during the diarrheal phase of disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hemolytic uremic syndrome
Key secondary outcomes

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 Shiga toxin-producing Escherichia coli infection cases registered from January 1st 2017 to December 31th 2018 under the infection law.
Key exclusion criteria 1. Asymptomatic patients.
2. Cases which researchers cannot reach the detailed information.
3. Cases whose form of questionnaires are not detailed.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Igarashi
Organization National Center for Child Health and Development
Division name Center
Zip code 157-8535
Address 2-10-1, Ookura, Setagaya ward, Tokyo
TEL 03-3416-0181
Email igarashi-t@ncchd.go.jp

Public contact
Name of contact person
1st name Isao
Middle name
Last name Miyairi
Organization National Center for Child Health and Development
Division name Division of Infectious diseases
Zip code 157-8535
Address 2-10-1, Ookura, Setagaya ward, Tokyo
TEL 03-3416-0181
Homepage URL
Email miyairi-s@ncchd.go.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

Funding Source
Organization Ministry of Health, Labour, and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National Center for Child Health and Development
Address 2-10-1, Ookura, Setagaya ward, Tokyo
Tel 03-3416-0181
Email hagino-k@ncchd.go.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
2019 Year 06 Month 28 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 Preinitiation
Date of protocol fixation
2019 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Not applicable

Management information
Registered date
2019 Year 06 Month 25 Day
Last modified on
2019 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042348

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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