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

Primary Purpose

Urolithiasis

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Ciprofloxacin
Placebo
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urolithiasis focused on measuring Antibiotics, Shock Wave Lithotripsy, Urinary Tract Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Joseph's Hospital, St. Joseph's Health Care London

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Ciprofloxacin

Arm Description

Placebo

Ciprofloxacin

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
June 3, 2013
Last Updated
February 4, 2016
Sponsor
Lawson Health Research Institute
Collaborators
The Physicians' Services Incorporated Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01873690
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Due to the low recruitment rate and the large number lost to follow-up
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
The Physicians' Services Incorporated Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
Keywords
Antibiotics, Shock Wave Lithotripsy, Urinary Tract Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Ciprofloxacin
Arm Type
Active Comparator
Arm Description
Ciprofloxacin
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Other Intervention Name(s)
Ciprofloxacin Hydrochloride
Intervention Description
Once, 400 mg IV
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
5% Dextrose in water
Primary Outcome Measure Information:
Title
Impact of antibiotic prophylaxis on the rate of urinary tract infection
Description
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).
Time Frame
Post SWL Day 7
Secondary Outcome Measure Information:
Title
Bacteriuria post-SWL (≥105 cfu/ml)
Time Frame
7-14 days
Title
Symptoms of cystitis (new onset burning sensation or pain with voiding, frequency, urgency)
Time Frame
7-14 days
Title
Pyelonephritis or urosepsis (hospital admission with fever ≥38.5C)
Time Frame
7-14 days
Title
Change in Urinary Symptom Score(reported as positive or negative integer)
Time Frame
7 - 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Razvi, MD, FRCSC
Organizational Affiliation
Western University & Lawson Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital, St. Joseph's Health Care London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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