UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003228
Receipt No. 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

* 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
Email

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
Email

Sponsor
Institute Department of Urology, Gifu University
Institute
Department

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
Email

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
URL(English) https://upload.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


Contact us.