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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000028607
Receipt No. R000032725
Scientific Title Efficacy of Tazobactam/Piperacillin on urosepsis (multicenter-study)
Date of disclosure of the study information 2017/08/10
Last modified on 2019/08/13

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Basic information
Public title Efficacy of Tazobactam/Piperacillin on urosepsis (multicenter-study)
Acronym Efficacy of TAZ/PIPC on urosepsis (multicenter-study)
Scientific Title Efficacy of Tazobactam/Piperacillin on urosepsis (multicenter-study)
Scientific Title:Acronym Efficacy of TAZ/PIPC on urosepsis (multicenter-study)
Region
Japan

Condition
Condition Urosepsis
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of TAZ/PIPC on urosepsis in multi-hospitals with various patients' backgrounds.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the change of subjective- and objective- symptoms and blood examination on 1, 2, 3 and 4 weeks of treatments.
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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Efficacy of Tazoctam/piperacillin(TAZ/PIPC) on urosepsis treatments
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria the patients with Urosepsis with consent of inclusion in this study
Key exclusion criteria 19 years older or younger or those patients without consent of inclusion in this study
Target sample size 114

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Fujisawa
Organization Kobe University Hospital
Division name Urology
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku
TEL 078-382-6155
Email masato@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsumi Shigemura
Organization Kobe University Hospital
Division name Urology, Health Science
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku
TEL 078-382-6155
Homepage URL
Email katsumi@med.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization Kobe University
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

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 10 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 Terminated
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
2018 Year 08 Month 20 Day
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
2019 Year 03 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 09 Day
Last modified on
2019 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032725

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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