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

Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01873690
• Other study ID #: 103696
• Status: Terminated
• Phase: Phase 3
• First received: June 3, 2013
• Last updated: February 4, 2016
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 360
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Urinary Tract Infections
• Urolithiasis

Intervention

Drug:
• Ciprofloxacin
Once, 400 mg IV
• Placebo
5% Dextrose in water

Locations

Country	Name	City	State
Canada	St. Joseph's Hospital, St. Joseph's Health Care London	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Bacteriuria post-SWL (=105 cfu/ml)		7-14 days	No
Secondary	Symptoms of cystitis (new onset burning sensation or pain with voiding, frequency, urgency)		7-14 days	No
Secondary	Pyelonephritis or urosepsis (hospital admission with fever =38.5C)		7-14 days	No
Secondary	Change in Urinary Symptom Score(reported as positive or negative integer)		7 - 14 days	No