UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005781 |
|---|---|
| Receipt number | R000006838 |
| Scientific Title | Antimicrobial prophylaxis with tazobactam/piperacilin for prevention of postoperative infections after radical cystectomy |
| Date of disclosure of the study information | 2011/06/15 |
| Last modified on | 2014/12/15 09:49:35 |
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Basic information
Public title
Antimicrobial prophylaxis with tazobactam/piperacilin for prevention of postoperative infections after radical cystectomy
Acronym
Antimicrobial prophylaxis with tazobactam/piperacilin for prevention of postoperative infections after radical cystectomy
Scientific Title
Antimicrobial prophylaxis with tazobactam/piperacilin for prevention of postoperative infections after radical cystectomy
Scientific Title:Acronym
Antimicrobial prophylaxis with tazobactam/piperacilin for prevention of postoperative infections after radical cystectomy
Region
| Japan |
Condition
Condition
Radical cystectomy
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prevent the postoperative infection of radical cystectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Infection
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
| Medicine |
Interventions/Control_1
TAZ/PIPC
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
The patients who undergo radical cystectomy
Key exclusion criteria
The patient who have allergy to TAZ/PIPC
The patient who do not agree the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazushi Tanaka |
Organization
Kobe University Graduate School of Medicine
Division name
Urology
Zip code
Address
7-5-1, Kusunokicho, Chuoku, Kobe, 650-0017, Japan
TEL
0783826155
kazushi@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazushi Tanaka |
Organization
Kobe University Graduate School of Medicine
Division name
Urology
Zip code
Address
Kobe
TEL
078-382-6155
Homepage URL
kazushi@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of 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
神戸大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 15 | 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
| 2011 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | 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 | 06 | Month | 15 | Day |
Last modified on
| 2014 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006838
