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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000032200
Receipt No. 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

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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
Email 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
Email katsumi@med.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036722

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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