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

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Collaborator: The Physicians' Services Incorporated Foundation
• Treatments: Anti-Infective Agents; Ciprofloxacin

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.