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Trial registered on ANZCTR
Registration number
ACTRN12619000053123
Ethics application status
Approved
Date submitted
22/12/2018
Date registered
15/01/2019
Date last updated
15/01/2019
Date data sharing statement initially provided
15/01/2019
Date results information initially provided
15/01/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Profile of pathogens causing acute cholangitis as a guide to antibiotics selection: A review of 395 acute cholangitis admissions in an Australian tertiary centre.
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Scientific title
Profile of pathogens causing acute cholangitis as a guide to antibiotics selection: A review of 395 acute cholangitis admissions in an Australian tertiary centre.
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Secondary ID [1]
296936
0
Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Biliary tract infection
311041
0
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Condition category
Condition code
Oral and Gastrointestinal
309562
309562
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Retrospective analysis of all admissions with acute cholangitis between January 2010 and December 2016. Each admission was categorised according to underlying aetiology, presence of biliary stent, choledocholithiasis, previous endoscopic biliary manipulation, immunosuppression, liver transplantation and representation. Each category was compared in relation to the pathogens grown, in-hospital length of stay (LOS) and Intensive Care Unit length of stay (ICU-LOS).
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Intervention code [1]
313210
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
318517
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In-hospital length of stay as assessed by review of medical records
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Assessment method [1]
318517
0
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Timepoint [1]
318517
0
Blood culture results for each acute cholangitis admission
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Secondary outcome [1]
365554
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Presence of choledocholithiasis in positive blood cultures as assessed by review of medical records
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Assessment method [1]
365554
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Timepoint [1]
365554
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Blood culture results for each acute cholangitis admission
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Secondary outcome [2]
365590
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Length of Intensive Care Unit stay as assessed by review of medical records'
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Assessment method [2]
365590
0
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Timepoint [2]
365590
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Blood culture results for each acute cholangitis admission
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Eligibility
Key inclusion criteria
Included only admissions with "definite" daignoses of acute cholangitis as per Tokyo Guidelines
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Minimum age
49
Years
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Maximum age
81
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
No exclusion criteria
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
Categorical variables were compared using Pearson chi-square or Fischer’s exact test for equal proportion as appropriated. Continuous variables were analysed using ANOVA and expressed in means and standard deviation (SD). P < 0.050 was considered significant. All statistical analysis was performed using SPSS for Windows, version 24.0 (SPSS, Chicago, IL, USA).
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
8/03/2017
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Date of last participant enrolment
Anticipated
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Actual
31/07/2017
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Date of last data collection
Anticipated
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Actual
1/08/2017
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Sample size
Target
300
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Accrual to date
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Final
395
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
12796
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
25256
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
301510
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Self funded/Unfunded
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Name [1]
301510
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Not funded
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Address [1]
301510
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Not funded
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Country [1]
301510
0
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Primary sponsor type
Hospital
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Name
Department of Surgery, The Austin Hospital
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Address
The Austin Hospital, Department of Surgery. Level 8, 145 Studley Rd, Heidelberg, Victoria, 3084, Australia.
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Country
Australia
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Secondary sponsor category [1]
301208
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None
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Name [1]
301208
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No sponsor
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Address [1]
301208
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No sponsor
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Country [1]
301208
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302252
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The Austin Health Human Research Ethics Committee
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Ethics committee address [1]
302252
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The Austin Hospital, Level 8, 145 Studley Rd, Heidelberg, Victoria, 3084, Australia.
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Ethics committee country [1]
302252
0
Australia
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Date submitted for ethics approval [1]
302252
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28/02/2017
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Approval date [1]
302252
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07/03/2017
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Ethics approval number [1]
302252
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LNR/17/Austin/122
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Summary
Brief summary
Australian data on pathogens causing acute cholangitis is lacking. Americian, European and Asian data state that E.Coli, Klebsiella species and Enterococcus species are the three most common pathogens causing acute cholangitis. This study aims to identify pathogens causing acute cholangitis from positive blood cultures in an Australian setting as a guide to antibiotics selection and to analyse their impact on in-hospital length of stay (LOS).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
89586
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Dr David Lan Cheong Wah
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Address
89586
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The Austin Hospital, Level 8, 145 Studley Rd, Heidelberg, Victoria, 3084, Australia.
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Country
89586
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Australia
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Phone
89586
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+61 406056467
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Fax
89586
0
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Email
89586
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[email protected]
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Contact person for public queries
Name
89587
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Dr David Lan Cheong Wah
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Address
89587
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The Austin Hospital, Level 8, 145 Studley Rd, Heidelberg, Victoria, 3084, Australia.
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Country
89587
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Australia
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Phone
89587
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+61 406056467
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Fax
89587
0
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Email
89587
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[email protected]
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Contact person for scientific queries
Name
89588
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Dr David Lan Cheong Wah
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Address
89588
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The Austin Hospital, Level 8, 145 Studley Rd, Heidelberg, Victoria, 3084, Australia.
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Country
89588
0
Australia
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Phone
89588
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+61 406056467
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Fax
89588
0
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Email
89588
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Number of acute cholangitis admissions.
Positive blood cultures.
Pathogens from positive blood cultures and in different admission groups
In-hospital length of stay
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When will data be available (start and end dates)?
01/12/2019 - 31/12/2019
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Available to whom?
Medical practitioners
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Available for what types of analyses?
Pearson chi-square or Fischer’s exact test
ANOVA
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How or where can data be obtained?
Publication of article
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
887
Ethical approval
376632-(Uploaded-10-01-2019-16-15-43)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF