The purpose of this research study is to test whether administering one dose of an antibiotic before a routine shock wave lithotripsy procedure is more effective at avoiding any urinary infections compared to not taking an antibiotic. This is an important topic to study because urinary tract infections are one of the most common complications after this procedure and there is no clear standard of care regarding the use of pre-procedure antibiotics. Our study results will benefit future patients either by decreasing the rate of infections or decreasing the use of unnecessary antibiotics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
360
Once, 400 mg IV
5% Dextrose in water
St. Joseph's Hospital, St. Joseph's Health Care London
London, Ontario, Canada
Impact of antibiotic prophylaxis on the rate of urinary tract infection
Our primary outcome will be a composite endpoint comprised of: Positive post-SWL urine culture (≥ 105 colony forming units / millilitre (CFU/ml), symptoms of cystitis (defined as new onset burning sensation or pain with voiding, frequency, urgency), or pyelonephritis or urosepsis (hospital admission with fever ≥38.5 C).
Time frame: Post SWL Day 7
Bacteriuria post-SWL (≥105 cfu/ml)
Time frame: 7-14 days
Symptoms of cystitis (new onset burning sensation or pain with voiding, frequency, urgency)
Time frame: 7-14 days
Pyelonephritis or urosepsis (hospital admission with fever ≥38.5C)
Time frame: 7-14 days
Change in Urinary Symptom Score(reported as positive or negative integer)
Time frame: 7 - 14 days
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