Clinical trial NCT01873690: Efficacy of Antimicrobial Prophylaxis for Shock Wave Lithotripsy (SWL) on Reducing Urinary Tract Infection (UTI)
Official title: A Randomized Controlled Trial Assessing the Efficacy of Antimicrobial Prophylaxis for Extracorporeal Shock Wave Lithotripsy on Reducing Urinary Tract Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Urolithiasis
Keywords: Antibiotics
Shock Wave Lithotripsy
Urinary Tract Infection
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2013-06-10
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Scheduled for SWL at St. Joseph's Hospital;
* 18 years of age or older;
* Willing and able to complete Questionnaires;
* Willing to submit urine sample for analysis at Day 7;
* Able to read and speak English.

Exclusion Criteria:

* Pre-SWL urine analysis positive for nitrites or urine culture reveals \>105 CFU/ml of bacteria (positive urine culture);
* Taking antibiotics for UTI or other cause;
* Requires an antibiotic post SWL;
* Suspected struvite stone (based on previous stone analysis, or partial staghorn);
* Presence of nephrostomy tube;
* Requiring cystoscopy on the day of SWL;
* Requiring ureteral stent on the day of SWL;
* Presence of indwelling urinary catheter or on regular clean intermittent catheterization (CIC);
* Presence of urinary diversion (ie: ileal conduit);
* Any history of urosepsis;
* Known allergic reaction to ciprofloxacin/quinolones;
* Patient known to be pregnant;
* Previous randomization in this trial;
* In the opinion of the urologist, it is not in the patient's best interest to participate.

Primary outcomes:
measure: Impact of antibiotic prophylaxis on the rate of urinary tract infection
timeFrame: Post SWL Day 7
Secondary outcomes:
measure: Bacteriuria post-SWL (≥105 cfu/ml)
timeFrame: 7-14 days
measure: Symptoms of cystitis (new onset burning sensation or pain with voiding, frequency, urgency)
timeFrame: 7-14 days
measure: Pyelonephritis or urosepsis (hospital admission with fever ≥38.5C)
timeFrame: 7-14 days
measure: Change in Urinary Symptom Score(reported as positive or negative integer)
timeFrame: 7 - 14 days
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Hospital, St. Joseph's Health Care London
state: Ontario
Study officials:
affiliation: Western University & Lawson Research Institute
name: Hassan Razvi, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: