UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012366 |
|---|---|
| Receipt number | R000014457 |
| Scientific Title | The study on hospital surveillance of Clostridium difficile infection |
| Date of disclosure of the study information | 2013/12/01 |
| Last modified on | 2019/06/07 15:43:20 |
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Basic information
Public title
The study on hospital surveillance of Clostridium difficile infection
Acronym
CDI surveillance
Scientific Title
The study on hospital surveillance of Clostridium difficile infection
Scientific Title:Acronym
CDI surveillance
Region
| Japan |
Condition
Condition
Clostridium difficile infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the incidence of Clostridium difficile infection(over 2 years old) in inpatient clinic
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The prevalence of Clostridium difficile infection
Key secondary outcomes
The risk factor of Clostridium difficile infection
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
| 2 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diarrhoea
CD toxin positive in stool
Key exclusion criteria
Normal stool
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soichi Arakawa |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Social/Community Medical and Health Science
Zip code
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5531
soichi@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Yoshida |
Organization
Kobe University Hospital
Division name
Department of Infection Control and Prevention
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5531
Homepage URL
hyoshida@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 12 | Month | 01 | 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
| 2013 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Molecular epidemiology study of Clostridium difficile infections in university hospitals:Results of a nationwide study in Japan:Tokimatsu I, Shigemura K, Osawa K, Kinugawa S, Kitagawa K, Nakanishi N, Yoshida H, Arakawa S, Fujisawa M on behalf of the Research Group of Japan Infection Prevention and Control Conference for National and Public University Hospitals J Infect Chemother 24(8):641-647 2018
Management information
Registered date
| 2013 | Year | 11 | Month | 20 | Day |
Last modified on
| 2019 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014457
| 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 |
