UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037168 |
|---|---|
| Receipt number | R000042352 |
| Scientific Title | Relation between antibiotics and bacterial shedding time of Enterohemorrhagic Escherichia coli infection patients, a retrospective cohort study |
| Date of disclosure of the study information | 2019/06/28 |
| Last modified on | 2019/06/25 14:38:11 |
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Basic information
Public title
Relation between antibiotics and bacterial shedding time of Enterohemorrhagic Escherichia coli infection patients, a retrospective cohort study
Acronym
Relation between antibiotics and bacterial shedding time of Enterohemorrhagic Escherichia coli infection patients, a retrospective cohort study
Scientific Title
Relation between antibiotics and bacterial shedding time of Enterohemorrhagic Escherichia coli infection patients, a retrospective cohort study
Scientific Title:Acronym
Relation between antibiotics and bacterial shedding time of Enterohemorrhagic Escherichia coli infection patients, a retrospective cohort study
Region
| Japan |
Condition
Condition
Infections caused by Escherichia coli
Classification by specialty
| Medicine in general | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between antibiotics and bacterial shedding time among Enterohemorrhagic Escherichia coli infections patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bacterial shedding time
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
Patients registered as Enterohemorrhagic Escherichia coli infections from January 1st 2017 to December 31th 2018 in Tokyo.
Key exclusion criteria
1. Cases whose form of questionnaires are not detailed.
2. Patients who died.
3. Patients who are not checked their negative stool culture.
Target sample size
770
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Igarashi |
Organization
National center for children health and development
Division name
Center
Zip code
157-8535
Address
2-10-1, Ookura, Setagaya ward, Tokyo
TEL
03-3416-0181
igarashi-t@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Miyairi |
Organization
National center for children 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
miyairi-s@ncchd.go.jp
Sponsor or person
Institute
National center for children health and development
Institute
Department
Personal name
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 children health and development
Address
2-10-1, Ookura, Setagaya ward, Tokyo
Tel
03-3416-0181
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 appicable
Management information
Registered date
| 2019 | Year | 06 | Month | 25 | Day |
Last modified on
| 2019 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042352
