Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000560695
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
30/09/2005
Date last updated
30/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A non-blinded randomised controlled study of the efficacy and safety of trimethoprim-sulfamethoxazole vs. norfloxacin for the prevention of spontaneous bacterial peritonitis in cirrhotic patients.
Scientific title
A non-blinded randomised controlled study of the efficacy and safety of trimethoprim-sulfamethoxazole vs. norfloxacin for the prevention of spontaneous bacterial peritonitis in cirrhotic patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cirrhosis 685 0
Ascites 686 0
Condition category
Condition code
Inflammatory and Immune System 760 760 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Compare the safety and efficacy of trimethoprim-sulfamethoxazole and norfloxacin in preventing spontaneous bacterial peritonitis. Duration is 12 months.
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 963 0
Rate of spontaneous bacterial peritonitis
Timepoint [1] 963 0
Primary outcome [2] 964 0
Rate of bacteraemia
Timepoint [2] 964 0
Secondary outcome [1] 1825 0
Rate of extraperitoneal bacterial infection
Timepoint [1] 1825 0
Secondary outcome [2] 1826 0
Rate of hospital admissions
Timepoint [2] 1826 0
Secondary outcome [3] 1827 0
Mortality rate
Timepoint [3] 1827 0
Secondary outcome [4] 1828 0
Side effects and tolerabilty to trimethoprim-sulfamethoxazole and norfloxacin
Timepoint [4] 1828 0
Secondary outcome [5] 1829 0
Resistance rates to trimethoprim-sulfamethoxazole and norfloxacin
Timepoint [5] 1829 0

Eligibility
Key inclusion criteria
Cirrhotic patient with ascites and either: 1) past history of spontaneous bacterial peritonitis, 2) ascitic protein concentration <15gm/L, 3) bilirubin >42micromol/L.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software performed by pharmacy department
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 841 0
Self funded/Unfunded
Name [1] 841 0
Country [1] 841 0
Primary sponsor type
Hospital
Name
Austin Health
Address
Country
Australia
Secondary sponsor category [1] 708 0
None
Name [1] 708 0
Nil
Address [1] 708 0
Country [1] 708 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35370 0
Address 35370 0
Country 35370 0
Phone 35370 0
Fax 35370 0
Email 35370 0
Contact person for public queries
Name 9782 0
Dr Steve Lontos
Address 9782 0
Gastroenterology Department
Austin Health
Studley Rd
Heidelberg VIC 3084
Country 9782 0
Australia
Phone 9782 0
+61 3 94965000
Fax 9782 0
Email 9782 0
[email protected]
Contact person for scientific queries
Name 710 0
Dr Paul Gow
Address 710 0
Gastroenterology Department
Austin Health
Studley Rd
Heidelberg VIC 3084
Country 710 0
Australia
Phone 710 0
+61 3 94965151
Fax 710 0
Email 710 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.