Status:
TERMINATED
Efficacy of Antimicrobial Prophylaxis for Shock Wave Lithotripsy (SWL) on Reducing Urinary Tract Infection (UTI)
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Conditions:
Urolithiasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 com...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT01873690
Start Date
November 1 2013
End Date
December 1 2015
Last Update
February 8 2016
Active Locations (1)
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1
St. Joseph's Hospital, St. Joseph's Health Care London
London, Ontario, Canada, N6A 4V2