UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028607 |
|---|---|
| Receipt number | 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 09:10:08 |
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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
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
katsumi@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032725
