UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006308 |
|---|---|
| Receipt number | R000007464 |
| Scientific Title | Detection of bacteria using by new generation sequencer in sepsis patients |
| Date of disclosure of the study information | 2011/09/08 |
| Last modified on | 2015/09/08 09:10:02 |
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Basic information
Public title
Detection of bacteria using by new generation sequencer in sepsis patients
Acronym
Detection of bacteria using by new generation sequencer
Scientific Title
Detection of bacteria using by new generation sequencer in sepsis patients
Scientific Title:Acronym
Detection of bacteria using by new generation sequencer
Region
| Japan |
Condition
Condition
Sepsis,Bacteremia
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Detection of bacteria i blood using by new generation sequencer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection of bacteria in blood
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Detection of bacteria in blood using by new generation sequencer
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
Sepsis and/or bacteremia patients who agreed attendance to this study
Key exclusion criteria
Sepsis and/or bacteremia patients who who could not agree attendance to this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Seki |
Organization
Osaka University Hospital
Division name
Division of Infection Control and Prevention
Zip code
Address
Yamadaoka 2-15, Suita City, Osaka, Japan
TEL
06-6879-5093
seki@hp-infect.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Seki |
Organization
Osaka University Hospital
Division name
Division of Infection Control and Prevention
Zip code
Address
Yamadaoka 2-15, Suita City
TEL
06-6879-5093
Homepage URL
seki@hp-infect.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University, Microbial Institute
Institute
Department
Personal name
Funding Source
Organization
Osaka University, Microbial Institute
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka University Medical Hospital
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
| 2011 | Year | 09 | Month | 08 | 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
Main results already published
Date of protocol fixation
| 2011 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
Management information
Registered date
| 2011 | Year | 09 | Month | 08 | Day |
Last modified on
| 2015 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007464
