UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028382 |
|---|---|
| Receipt number | R000032491 |
| Scientific Title | Safety and Effectiveness of Short Course Anrtimicrobial Therapy for Acute Cholangitis: Open-label Randomized Controlled Trial |
| Date of disclosure of the study information | 2017/08/30 |
| Last modified on | 2020/07/28 11:58:01 |
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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
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
kobeid@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
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
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
Value
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
