Study comparing antibiotics versus placebo at time of catheter removal post robotic prostate removal

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.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000768190

Acronym

TRAP Trial

Enrollment

800

Registered

2019-05-23

Start date

2019-06-03

Completion date

2020-12-01

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Men undergoing robot assisted laparoscopic radical prostatectomy at the Wesley Hospital

Exclusion criteria

non-robotic prostatectomy positive preoperative urine culture previous allergy to ceftriaxone

Outcome results