UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007935 |
|---|---|
| Receipt number | R000009342 |
| Scientific Title | Qualitative evaluation of blood cultures and epidemiology of treatment of septicemia in Japanese hospitals |
| Date of disclosure of the study information | 2012/05/12 |
| Last modified on | 2013/05/29 10:40:27 |
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Basic information
Public title
Qualitative evaluation of blood cultures and epidemiology of treatment of septicemia in Japanese hospitals
Acronym
Qualitative evaluation of blood cultures and epidemiology of treatment of septicemia in Japanese hospitals
Scientific Title
Qualitative evaluation of blood cultures and epidemiology of treatment of septicemia in Japanese hospitals
Scientific Title:Acronym
Qualitative evaluation of blood cultures and epidemiology of treatment of septicemia in Japanese hospitals
Region
| Japan |
Condition
Condition
bacteremia
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purposes of this research are the qualitative evaluation of the examination of blood culture examination, and the analysis of clinical information of BSIs.
Basic objectives2
Others
Basic objectives -Others
Evaluation of catheter-related BSI (CRBSI )
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
*Evaluation of the situation regarding blood culture collection (two sets rate, contamination rate)
*Evaluation of catheter-related BSI (CRBSI )(central venous catheters, peripheral venous catheters)
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
all blood culture positive cases
Key exclusion criteria
none
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Ohmagari |
Organization
National Center for Global Health and Medicine
Division name
Disease Control and Prevention Center
Zip code
Address
1-21-1 Toyama, Shinjyuku-ku, Tokyo
TEL
03-3202-7181
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nozomi Takeshita |
Organization
National Center for Global Health and Medicine
Division name
Disease Control and Prevention Center
Zip code
Address
1-21-1 Toyama, Shinjyuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
nozomitake@gmail.com
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 05 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
 Hospital information: Hospital bed capacity, availability of emergency medical treatment, number of blood culture examinations (nosocomial, community-acquired)
 Clinical information: Age, sex, diagnosis, culture-positive days, information such as date antimicrobial started, department , microorganism name, date blood culture preformed, ward in which blood culture is preformed, length of hospital stay, discharge day, presence of venues catheter lines, clinical outcome, evidence of consultation with infectious disease department, etc.
Management information
Registered date
| 2012 | Year | 05 | Month | 12 | Day |
Last modified on
| 2013 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009342
| 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 |
