UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051276 |
|---|---|
| Receipt number | R000058483 |
| Scientific Title | Clinicoepidemiological and microbiological evaluation of community-acquired ESBL Escherichia coli infections |
| Date of disclosure of the study information | 2023/06/07 |
| Last modified on | 2023/06/07 11:36:03 |
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Basic information
Public title
Clinicoepidemiological and microbiological evaluation of community-acquired ESBL Escherichia coli infections
Acronym
CA-ESBLEC_JAPAN study
Scientific Title
Clinicoepidemiological and microbiological evaluation of community-acquired ESBL Escherichia coli infections
Scientific Title:Acronym
CA-ESBLEC_JAPAN study
Region
| Japan |
Condition
Condition
Infections due to ESBL-E. coli
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Clinico-epidemiologic evaluation of community-onset ESBL Escherichia coli infections and identification of risk factors
Basic objectives2
Others
Basic objectives -Others
Evaluation of the association between molecular microbiological and clinical epidemiological features of ESBL E. coli infections
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Clinical-epidemiologic evaluation of community-onset ESBL E. coli infections and identification of risk factors
1) -1: Risk assessment of community-onset ESBL E. coli infection (comparison with community-onset 3GCS E. coli infection)
Descriptive and univariate analysis of the clinical-epidemiologic characteristics of community-acquired ESBL-producing E. coli infections compared to susceptible strains will be conducted and independent risk factors for infection will be identified.
1)-2: Risk assessment of community-acquired ESBL E. coli infections (vs. nosocomial ESBL E. coli infections)
Descriptive and univariate analyses to identify the clinico-epidemiologic characteristics of community-acquired ESBL E. coli infection compared to nosocomial infection will be conducted and independent risk factors for infection will be identified.
2) Evaluation of the association between molecular microbiological and clinical-epidemiological characteristics of ESBL E. coli infection.
Descriptive and univariate analyses will be performed on molecular microbiological parameters to identify differences between community and nosocomial cases, the presence of nosocomial infection, and clinical epidemiological characteristics, as well as the presence or absence of spread of specific clones and geographic bias.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age 18 years and older
Bacteriological diagnosis
ESBL-producing E. coli detected in clinical specimens (case group)
Non-ESBL-producing (3GCS: 3rd generation cephalosporin-susceptible) E. coli detected in clinical specimens within 3 days of admission or in outpatient setting (control group)
Key exclusion criteria
Cases deemed inappropriate for inclusion in the study by the principal investigator (e.g., significant missing medical record data)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | Hayakawa |
Organization
National Center for Global Health and Medicine
Division name
Department of Infectious Diseases/Disease Control and Prevention Center
Zip code
1628655
Address
1-21-1 Toyama, Shinjuku, Tokyo, Japan
TEL
03-3202-7181
khayakawa@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Kayoko |
| Middle name | |
| Last name | Hayakawa |
Organization
National Center for Global Health and Medicine
Division name
Department of Infectious Diseases/Disease Control and Prevention Center
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
khayakawa@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoto University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine, IRB
Address
1-21-1 Toyama, Shinjuku, Tokyo, Japan
Tel
03-3202-7181
rinri@hosp.ncgm.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
| 2023 | Year | 06 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing particular
Management information
Registered date
| 2023 | Year | 06 | Month | 07 | Day |
Last modified on
| 2023 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058483
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
