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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

5% Dextrose in water

Ciprofloxacin

Group Type ACTIVE_COMPARATOR

Ciprofloxacin

Intervention Type DRUG

Once, 400 mg IV

Interventions

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Ciprofloxacin

Once, 400 mg IV

Intervention Type DRUG

Placebo

5% Dextrose in water

Intervention Type DRUG

Other Intervention Names

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Ciprofloxacin Hydrochloride

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No