UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000036722