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

A Randomized Controlled Trial Assessing the Efficacy of Antimicrobial Prophylaxis for Extracorporeal Shock Wave Lithotripsy on Reducing Urinary Tract Infection

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 Overview

• Status: Terminated
• Conditions: Urolithiasis
• Intervention / Treatment: Drug: Placebo; Drug: Ciprofloxacin

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St. Joseph's Hospital, St. Joseph's Health Care London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 5% Dextrose in water
Active Comparator: Ciprofloxacin	Drug: Ciprofloxacin; Once, 400 mg IV; Other Names: Ciprofloxacin Hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Post SWL Day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: The Physicians' Services Incorporated Foundation
• Investigators: Principal Investigator: Hassan Razvi, MD, FRCSC, Western University & Lawson Research Institute

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 3, 2013
• First Submitted That Met QC Criteria: June 7, 2013
• First Posted (Estimate): June 10, 2013

Study Record Updates

• Last Update Posted (Estimate): February 8, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Antibiotics; Urinary Tract Infection; Shock Wave Lithotripsy
• Additional Relevant MeSH Terms: Urologic Diseases; Infections; Urinary Tract Infections; Urolithiasis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: 103696

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No