UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003228 |
|---|---|
| Receipt number | R000003908 |
| Scientific Title | Clinical effectiveness and safety of TAZ/PIPC (YP-18) 4.5g for the prevention of infectious complication of prostate biopsy |
| Date of disclosure of the study information | 2010/02/22 |
| Last modified on | 2013/10/02 09:46:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical effectiveness and safety of TAZ/PIPC (YP-18) 4.5g for the prevention of infectious complication of prostate biopsy
Acronym
Antimicrobial prophylaxis for the infectious complication of the prostate biopsy
Scientific Title
Clinical effectiveness and safety of TAZ/PIPC (YP-18) 4.5g for the prevention of infectious complication of prostate biopsy
Scientific Title:Acronym
Antimicrobial prophylaxis for the infectious complication of the prostate biopsy
Region
| Japan |
Condition
Condition
Suspected prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
TAZ/PIPC 2.5g x 3 was recommended for the prevention of infectious complication of the prostate biopsy in the guideline for the prevention of perioperative infection. Clinical effectiveness and safety of TAZ/PIPC (YP-18) 4.5g are examined in this study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical effectiveness and safety of TAZ/PIPC (YP-18) 4.5g for the prevention of infectious complication of prostate biopsy.
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/PIPI (YP-18) 4.5g is administered one or two times on the day of prostate biopsy
*Two times which is 30 min before biopsy and after the prostate biopsy (just before discharge or 5hours after the biopsy
*Three times of estimation of efficacy at before, 1-4 days and 6-10 days after biopsy
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
Key inclusion criteria
Patient received prostate biopsy
Key exclusion criteria
1.Patient who has allergy against the TAZ/PIPC or compounds of penicillins
2.Patient who has infectious mononucleosis
3.Others whom doctors in charge considered to be not apropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuru Yasuda |
Organization
Gifu University
Division name
Department of Urology
Zip code
Address
1-1, Yanagido, Gifu city, Gifu prefecture
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Gifu University
Division name
Department of Urology
Zip code
Address
1-1, Yanagido, Gifu city, Gifu prefecture
TEL
Homepage URL
Sponsor or person
Institute
Department of Urology, Gifu University
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
岐阜大学附属病院（岐阜県）、産業医科大学附属病院（福岡県）、神戸大学附属病院（兵庫県）、広島大学附属病院（広島県）、宮崎大学附属病院（宮崎県）、鹿児島大学附属病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 22 | 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
| 2009 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | 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
| 2010 | Year | 02 | Month | 22 | Day |
Last modified on
| 2013 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003908
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
