UMIN-CTR Clinical Trial

Basic information
Public title	Safety and Effectiveness of Short Course Anrtimicrobial Therapy for Acute Cholangitis: Open-label Randomized Controlled Trial
Acronym	Short Course Anrtimicrobial Therapy for Acute Cholangitis
Scientific Title	Safety and Effectiveness of Short Course Anrtimicrobial Therapy for Acute Cholangitis: Open-label Randomized Controlled Trial
Scientific Title:Acronym	Short Course Anrtimicrobial Therapy for Acute Cholangitis
Region	Japan

Condition
Condition	acute cholangitis
Classification by specialty	Gastroenterology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	As one modality of antimicrobial stewardship programs, studies have been conducted to investigate safety and effectiveness of short course antibiotic therapy. We plan to conduct a multi-center open label randomized controlled trial to compare short course therapy with conventional therapy to evaluate its effectiveness and safety.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	30 day mortality
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	short course therapy
Interventions/Control_2	conventional therapy
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	Patients with acute cholangitis diagnosed by gastroenterologists, and those permitted to be intervened by Infectious Diseases doctors. In addition, there should not be bile duct obstruction or such obstruction was cured by intervention such as ERCP.
Key exclusion criteria	Not consented by either the patient or treating physicians. Bile duct obstruciton was not released.
Target sample size	182

Research contact person
Name of lead principal investigator	1st name Kentaro Middle name Last name Iwata
Organization	Kobe University
Division name	Division of Infectious Diseases
Zip code	6500017
Address	Kusunokicho 7-5-2, Chuoku, Kobe
TEL	078-382-6297
Email	kentaroiwata1969@gmail.com

Public contact
Name of contact person	1st name Toko Middle name Last name Nakata
Organization	Kobe University
Division name	Division of Infectious Diseases
Zip code	6500017
Address	Kusunokicho 7-5-2, Chuoku, Kobe
TEL	078-382-6297
Homepage URL
Email	kobeid@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	not applicable
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	Kobe University
Address	Kusunokicho 7-5-2, Chuoku, Kobe
Tel	078-382-6669
Email	kainyu@med.kobe-u.ac.jp

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 30 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	Preinitiation
Date of protocol fixation	2017 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date	2017 Year 09 Month 30 Day
Last follow-up date	2021 Year 12 Month 31 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 07 Month 26 Day
Last modified on	2020 Year 07 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032491

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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