UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study on biliary infection therapy :A RCT on clinical efficacy of DRPM in biliary tract infection with IPM/CS as comparator
Acronym	Clinical study on biliary infection therapy
Scientific Title	Clinical study on biliary infection therapy :A RCT on clinical efficacy of DRPM in biliary tract infection with IPM/CS as comparator
Scientific Title:Acronym	Clinical study on biliary infection therapy
Region	Japan

Condition
Condition	Acute biliaring infection
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy of DRPM on biliary infection
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	Clinical effectiveness
Key secondary outcomes	Clinical effectiveness at 3,7days Safety(moniterd clinical and laboratory evaluation)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	DRPM
Interventions/Control_2	IPM/CS
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	Acute biliary infection
Key exclusion criteria	1)History of hypersensitivity to DRPM 2)Serious complications 3)Serious cardiac disfunctions 4)Serious renal disfunctions 5)With CNS disorder 6)History of hypersensitivity to B-lactam antibiotics 7)Pregnant or lactating women and women who may be pregnant 8)MRSA infection 9)Judged by investigator not to be appropriate for inclusion in this study
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Susumu Tazuma
Organization	graduate school of biomedicalscience, Hiroshima university.
Division name	Department of General Medicine
Zip code
Address	1-2-3,Kasumi,Minami-Ku,Hiroshima
TEL	082-257-5461
Email	stazuma@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Susumu Tazuma
Organization	graduate school of biomedicalscience, Hiroshima university.
Division name	Department of General Medicine
Zip code
Address	1-2-3,Kasumi,Minami-Ku,Hiroshima
TEL	082-257-5461
Homepage URL
Email	stazuma@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima university hospital Department of General Internal Medicine
Institute
Department

Funding Source
Organization	Hiroshima university hospital Department of General Internal Medicine
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	広島大学大学院（広島県）　 東邦大学医療センター大森病院（東京都） 藤田保健衛生大学坂文種報徳會病院（愛知県） 名古屋市立大学大学院（愛知県） 千葉大学大学院医学究院（千葉県） 山口大学大学院（山口県）

Other administrative information
Date of disclosure of the study information	2010 Year 07 Month 01 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	Completed
Date of protocol fixation	2010 Year 03 Month 16 Day
Date of IRB	2010 Year 06 Month 01 Day
Anticipated trial start date	2010 Year 06 Month 01 Day
Last follow-up date	2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 07 Month 01 Day
Last modified on	2019 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004259