Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000768190
Ethics application status
Approved
Date submitted
15/05/2019
Date registered
23/05/2019
Date last updated
23/05/2019
Date data sharing statement initially provided
23/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Study comparing antibiotics versus placebo at time of catheter removal post robotic prostate removal
Scientific title
A Randomised controlled trial of ceftriaxone versus placebo for prevention of urinary tract infections at trial of void post robotic laparoscopic radical prostatectomy in patients with prostate cancer.
Secondary ID [1] 298235 0
Nil Known
Universal Trial Number (UTN)
U1111-1233-4290
Trial acronym
TRAP Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
urinary tract infection 312835 0
prostate cancer 312836 0
Condition category
Condition code
Infection 311337 311337 0 0
Studies of infection and infectious agents
Cancer 311338 311338 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ceftriaxone versus placebo at Trial of Void

Intervention Group
- drug Ceftriaxone
- dose 1g once
- duration - NA
- mode intravaneous injection
- timing - at removal of catheter (seven days post prostatectomy)
- administeration - medically trained research fellow
Intervention code [1] 314481 0
Prevention
Comparator / control treatment
Placebo Group
- drug normal saline (0.9%)
- dose 10ml once
- duration - NA
- mode intravaneous injection
Control group
Placebo

Outcomes
Primary outcome [1] 320066 0
symptomatic urinary tract infection (UTI)
- positive urine culture and
- positive lower urinary tract symptoms (weekly international prostate symptom score) and/or systemic infective symptoms assessed by research fellow .

*this is a composite primary outcome
Timepoint [1] 320066 0
first 4 weeks post robot assisted laparoscopic radical prostatectomy
- urine sample will be collected at time of trial of void and weekly for four weeks post prostatectomy unless the participant becomes symptomatic then it will be repeated according to standard of care for UTI management
- participants will be assessed for symptoms as a single assessment at time of trial of void and they will be advised to self report any signs or symptoms of UTI to treating urologist or GP in the followup period
Secondary outcome [1] 370418 0
asymptomatic bacteriuria
- positive urine culture
- without any evidence of new lower urinary tract symptoms or systemic infective symptoms - participants will be asked at trial of void about these symptoms in a study specific questionnaire and will be advised to self report any signs or symptoms of UTI to treating urologist or GP in the followup period
Timepoint [1] 370418 0
30 days following robot assisted laparoscopic radical prostatectomy

Eligibility
Key inclusion criteria
Men undergoing robot assisted laparoscopic radical prostatectomy at the Wesley Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
non-robotic prostatectomy
positive preoperative urine culture
previous allergy to ceftriaxone

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)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
comparative statistics will be undertaken to determine differences in (a)symptomatic infection rates between groups

power calculations are based on the basis that 5% risk of symptomatic infection without antibiotics

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2019
Actual
Date of last participant enrolment
Anticipated
1/12/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13738 0
The Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 26486 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 302775 0
Charities/Societies/Foundations
Name [1] 302775 0
Wesley Medical Research
Country [1] 302775 0
Australia
Primary sponsor type
Individual
Name
A/Prof John Yaxley
Address
Wesley Urology Clinic
The Wesley Hospital
Suite 42, level 4
40 Chasely Street
Auchenflower QLD 4066
Country
Australia
Secondary sponsor category [1] 302719 0
None
Name [1] 302719 0
Address [1] 302719 0
Country [1] 302719 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303372 0
UnitingCare Health HREC
Ethics committee address [1] 303372 0
Upper Floor Moorlands House, The Wesley Hospital
451 Coronation Drive
Auchenflower
QLD 4066
Ethics committee country [1] 303372 0
Australia
Date submitted for ethics approval [1] 303372 0
Approval date [1] 303372 0
02/03/2018
Ethics approval number [1] 303372 0

Summary
Brief summary
The purpose of this study is to determine if the use of an antibiotic (Ceftriaxone) post-radical prostatectomy will help prevent urinary tract infections in patients with a indwelling catheter inserted at time of trial of void.

You may be eligible for this study if you have prostate cancer and are undergoing a robot assisted laparoscopic radical prostatectomy at the Wesley Hospital.

Study details
Participants will be randomly allocated to one of two groups, the intervention group (standard care) or the placebo group. The procedure in the intervention group will involve:
a) Injecting 1g of antibiotic (Ceftriaxone) via an injection in the arm at time of catheter removal (one week post-surgery).
b) Collection of urine samples and blood

The placebo group will receive:
a) Injecting 10ml of saline via an injection in the arm at time of catheter removal (one week post-surgery).
b) Collection of urine samples and blood

It is hoped that this study will determine if antibiotics reduce the incidence of symptomatic urinary tract infections after catheter removal as currently they are being given to every person, which may lead to increased antibiotic resistance if they are not actually required.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93438 0
A/Prof John Yaxley
Address 93438 0
Wesley Urology Clinic
Sutie 42, Level 4
40 Chasely St
Auchenflower QLD 4066
Country 93438 0
Australia
Phone 93438 0
+61 7 3720 6950
Fax 93438 0
Email 93438 0
[email protected]
Contact person for public queries
Name 93439 0
John Yaxley
Address 93439 0
Wesley Urology Clinic
Sutie 42, Level 4
40 Chasely St
Auchenflower QLD 4066
Country 93439 0
Australia
Phone 93439 0
+61 7 3720 6950
Fax 93439 0
Email 93439 0
[email protected]
Contact person for scientific queries
Name 93440 0
John Yaxley
Address 93440 0
Wesley Urology Clinic
Sutie 42, Level 4
40 Chasely St
Auchenflower QLD 4066
Country 93440 0
Australia
Phone 93440 0
+61 7 3720 6950
Fax 93440 0
Email 93440 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.