Efficacy of Antimicrobial Prophylaxis for Shock Wave Lithotripsy (SWL) on Reducing Urinary Tract Infection (UTI)

Phase 3

Terminated

• Conditions: Urolithiasis
• Interventions: Drug: Placebo; Drug: Ciprofloxacin

• Registration Number: NCT01873690
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-10
• Study Start: 2013-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Ciprofloxacin	Ciprofloxacin	Ciprofloxacin

Primary Outcome Measures

Name	Time	Method
Impact of antibiotic prophylaxis on the rate of urinary tract infection	Post SWL Day 7	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).

Secondary Outcome Measures

Name	Time	Method
Bacteriuria post-SWL (≥105 cfu/ml)	7-14 days
Symptoms of cystitis (new onset burning sensation or pain with voiding, frequency, urgency)	7-14 days
Pyelonephritis or urosepsis (hospital admission with fever ≥38.5C)	7-14 days
Change in Urinary Symptom Score(reported as positive or negative integer)	7 - 14 days

Trial Locations

Locations (1)

St. Joseph's Hospital, St. Joseph's Health Care London; 🇨🇦 London, Ontario, Canada