UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032200 |
|---|---|
| Receipt number | R000036722 |
| Scientific Title | Multi-center study for efficacy of TAZ/PIPC on catheter-associated urinary tract infection (CAUTI) |
| Date of disclosure of the study information | 2018/04/11 |
| Last modified on | 2019/05/03 23:31:03 |
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Basic information
Public title
Multi-center study for efficacy of TAZ/PIPC on catheter-associated urinary tract infection (CAUTI)
Acronym
Efficacy of TAZ/PIPC on catheter-associated urinary tract infection (CAUTI)
Scientific Title
Multi-center study for efficacy of TAZ/PIPC on catheter-associated urinary tract infection (CAUTI)
Scientific Title:Acronym
Efficacy of TAZ/PIPC on catheter-associated urinary tract infection (CAUTI)
Region
| Japan |
Condition
Condition
Catheter-associated urinary tract infection
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of Tazobactam/Piperacillin (TAZ/PIPC) on catheter-associated urinary tract infection (CAUTI)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TAZ/PIPC 13.5g/day treatment on CAUTI will be done for 1 week and 1st outcome evaluation will be don, then antibiotics will be switched to oral one by de-escalation for another a week. Then, 2nd outcome evaluation will be done. Then, after 1 week of no-administration of antibiotics, 3rd outcome evaluation will be undertaken.Basically outcome evaluation is done by symptom of infectious diseases.
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
TAZ/PIPC group 13.5g/day for 1 week
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those patients with CAUTI who are older than 20 years old.
Key exclusion criteria
Those patients with allergy for TAZ/PIPC.
Those patients with the previous UTI whiose causative bacteria showed TAZ/PIPC-resistance.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Fujisawa |
Organization
Kobe University
Division name
Urology
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe,
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
Division name
Urology
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe,
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
Other
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
| 2018 | Year | 04 | Month | 11 | 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
| 2018 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 07 | 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
| 2018 | Year | 04 | Month | 11 | Day |
Last modified on
| 2019 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036722
