UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002677 |
|---|---|
| Receipt number | R000001452 |
| Scientific Title | Effectiveness of polymyxin B on severe infections caused by multi-drug resistant Gram negative organisms |
| Date of disclosure of the study information | 2011/05/31 |
| Last modified on | 2009/10/27 10:06:25 |
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Basic information
Public title
Effectiveness of polymyxin B on severe infections caused by multi-drug resistant Gram negative organisms
Acronym
Effectiveness of polymyxin B on MDRGNOs
Scientific Title
Effectiveness of polymyxin B on severe infections caused by multi-drug resistant Gram negative organisms
Scientific Title:Acronym
Effectiveness of polymyxin B on MDRGNOs
Region
| Japan |
Condition
Condition
Severe infections caused by multi-drug resistant Gram negative organisms
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
effectiveness/safety measurement of polymyxin B
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
death
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
polymyxin B intravenous
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
severe infections caused by multi-drug resistant Gram negative organisms where no other antibiotics are available otherwise.
Key exclusion criteria
refusal by patients or their surrogates
presence of alternative therapeutic agents
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Iwata |
Organization
Kobe University
Division name
Division of Infectious Diseases Therapeutics
Zip code
Address
Kusunoki-cho 7-5-1, Chuo-ku, Kobe
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University
Division name
Division of Infectious Diseases Therapeutics
Zip code
Address
TEL
078-382-5111
Homepage URL
Sponsor or person
Institute
Division of Infectious Diseases Therapeutics. Kobe university
Institute
Department
Personal name
Funding Source
Organization
Study on emergent and re-emergent infectious diseases. Ministry of Health, Labor and Welfare
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
| 2011 | Year | 05 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2008 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 27 | Day |
Last modified on
| 2009 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001452
