UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010121 |
|---|---|
| Receipt number | R000011851 |
| Scientific Title | The clinical utility of Clostridium difficile gene detection by BD MAX Cdiff System |
| Date of disclosure of the study information | 2013/03/01 |
| Last modified on | 2015/12/04 15:28:43 |
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Basic information
Public title
The clinical utility of Clostridium difficile gene detection by BD MAX Cdiff System
Acronym
The clinical study of BD MAX Cdiff System
Scientific Title
The clinical utility of Clostridium difficile gene detection by BD MAX Cdiff System
Scientific Title:Acronym
The clinical study of BD MAX Cdiff System
Region
| Japan |
Condition
Condition
Clostridium difficile infecction
Classification by specialty
| Gastroenterology | Infectious disease | Geriatrics |
| Laboratory medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of the utility of BD MAX Cdiff System for Clostridium difficile infection
Basic objectives2
Others
Basic objectives -Others
The evaluation of BD MAX Cdiff System for Clostridium dificile infection compared to toxigenic cuture and existing IVDP
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The concordance rate between BD MAX Cdiff System and clinical diagnosis for Clostridium difficile infection
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A patient who shows CDAD or is diagnosed as CDI
Key exclusion criteria
not applicable
Target sample size
470
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshishige Masuda |
Organization
Tokyo Metropolitan Geriatric Hospital
Division name
General/Inefction internal medicine
Zip code
Address
Sakae 35-2, Itabashi-ku, Tokyo, Japan
TEL
03-3964-1141
masudayo@tmghig.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Tomaru |
Organization
Nippon Nippon Becton Dickinson Company, Ltd.
Division name
Medical Affairs
Zip code
Address
Akasaka4-15-1, Minato-ku, Tokyo, Japan
TEL
03-6234-5490
Homepage URL
takeshi_tomaru@bd.com
Sponsor or person
Institute
Nippon Becton Dickinson Company, Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nippon Becton Dickinson Company, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
Tokyo Metropolitan Hospital
Toyokawa Municipal Hospital
Nagasaki University Hospital
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | 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
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Continuous subject entry/Case series study
Management information
Registered date
| 2013 | Year | 02 | Month | 26 | Day |
Last modified on
| 2015 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011851
