UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051650 |
|---|---|
| Receipt number | R000057460 |
| Scientific Title | Multicenter epidemiological study of Clostridium bacteremia |
| Date of disclosure of the study information | 2023/07/20 |
| Last modified on | 2023/07/19 17:29:54 |
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Basic information
Public title
Multicenter epidemiological study of Clostridium bacteremia
Acronym
Epidemiological study of Clostridium bacteremia
Scientific Title
Multicenter epidemiological study of Clostridium bacteremia
Scientific Title:Acronym
Epidemiological study of Clostridium bacteremia
Region
| Japan |
Condition
Condition
Clostridium bacteremia
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to investigate the clinical epidemiology of Clostridium bacteremia.
Basic objectives2
Others
Basic objectives -Others
The objective is to investigate the microbiological epidemiology of Clostridium bacteremia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical and microbiological epidemiology of clostridium bacteremia
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 whose blood culture specimens were detected with Clostridium spp. at the University of Tokyo Hospital and collaborating hospitals between 01/01/2007 and 12/31/2021.
Key exclusion criteria
A brief description of the study will be posted on the website and an opt-out period will be provided during which patients may express their refusal to participate in the study. Patients who request not to participate in the study during the opt-out period will be excluded from the study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shu |
| Middle name | |
| Last name | Okugawa |
Organization
The University of Tokyo Hospital
Division name
Department of Infectious Diseases
Zip code
1138655
Address
7-3-1 Hongo Bunkyoku Tokyo
TEL
0338155411
okugawa-tky@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Shu |
| Middle name | |
| Last name | Okugawa |
Organization
The University of Tokyo Hospital
Division name
Department of Infectious Diseases
Zip code
1138655
Address
7-3-1 Hongo Bunkyoku Tokyo
TEL
0338155411
Homepage URL
okugawa-tky@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Shu Okugawa
Funding Source
Organization
The University of Tokyo Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1 Hongo Bunkyoku Tokyo
Tel
0358410818
ethics@m.u-tokyo.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
さいたま市立病院（埼玉県）、三井記念病院（東京都）、帝京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 20 | 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
| 2023 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2023 | Year | 07 | Month | 19 | Day |
Last modified on
| 2023 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057460
| Research Plan | |
|---|---|
| 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 |
