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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.
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.
Secondary ID [1] 296936 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Biliary tract infection 311041 0
Condition category
Condition code
Oral and Gastrointestinal 309562 309562 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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).
Intervention code [1] 313210 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318517 0
In-hospital length of stay as assessed by review of medical records
Timepoint [1] 318517 0
Blood culture results for each acute cholangitis admission
Secondary outcome [1] 365554 0
Presence of choledocholithiasis in positive blood cultures as assessed by review of medical records
Timepoint [1] 365554 0
Blood culture results for each acute cholangitis admission
Secondary outcome [2] 365590 0
Length of Intensive Care Unit stay as assessed by review of medical records'
Timepoint [2] 365590 0
Blood culture results for each acute cholangitis admission

Eligibility
Key inclusion criteria
Included only admissions with "definite" daignoses of acute cholangitis as per Tokyo Guidelines
Minimum age
49 Years
Maximum age
81 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
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).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/03/2017
Date of last participant enrolment
Anticipated
Actual
31/07/2017
Date of last data collection
Anticipated
Actual
1/08/2017
Sample size
Target
300
Accrual to date
Final
395
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12796 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 25256 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 301510 0
Self funded/Unfunded
Name [1] 301510 0
Not funded
Country [1] 301510 0
Primary sponsor type
Hospital
Name
Department of Surgery, The Austin Hospital
Address
The Austin Hospital, Department of Surgery. Level 8, 145 Studley Rd, Heidelberg, Victoria, 3084, Australia.
Country
Australia
Secondary sponsor category [1] 301208 0
None
Name [1] 301208 0
No sponsor
Address [1] 301208 0
No sponsor
Country [1] 301208 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302252 0
The Austin Health Human Research Ethics Committee
Ethics committee address [1] 302252 0
The Austin Hospital, Level 8, 145 Studley Rd, Heidelberg, Victoria, 3084, Australia.
Ethics committee country [1] 302252 0
Australia
Date submitted for ethics approval [1] 302252 0
28/02/2017
Approval date [1] 302252 0
07/03/2017
Ethics approval number [1] 302252 0
LNR/17/Austin/122

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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89586 0
Dr David Lan Cheong Wah
Address 89586 0
The Austin Hospital, Level 8, 145 Studley Rd, Heidelberg, Victoria, 3084, Australia.
Country 89586 0
Australia
Phone 89586 0
+61 406056467
Fax 89586 0
Email 89586 0
[email protected]
Contact person for public queries
Name 89587 0
David Lan Cheong Wah
Address 89587 0
The Austin Hospital, Level 8, 145 Studley Rd, Heidelberg, Victoria, 3084, Australia.
Country 89587 0
Australia
Phone 89587 0
+61 406056467
Fax 89587 0
Email 89587 0
[email protected]
Contact person for scientific queries
Name 89588 0
David Lan Cheong Wah
Address 89588 0
The Austin Hospital, Level 8, 145 Studley Rd, Heidelberg, Victoria, 3084, Australia.
Country 89588 0
Australia
Phone 89588 0
+61 406056467
Fax 89588 0
Email 89588 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
01/12/2019 - 31/12/2019
Available to whom?
Medical practitioners
Available for what types of analyses?
Pearson chi-square or Fischer’s exact test
ANOVA
How or where can data be obtained?
Publication of article


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
887Ethical 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.