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

NCT01873690 | Terminated Phase 3

• 1 other identifier: 103696
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis

Keywords

Antibiotics; Shock Wave Lithotripsy; Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Ciprofloxacin

ACTIVE COMPARATOR

Ciprofloxacin

Drug: Ciprofloxacin

Interventions

Ciprofloxacin DRUG

Once, 400 mg IV

Also known as: Ciprofloxacin Hydrochloride

Ciprofloxacin

Placebo DRUG

5% Dextrose in water

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for SWL at St. Joseph's Hospital;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

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

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Urolithiasis; Urinary Tract Infections

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hassan Razvi, MD, FRCSC

  Western University & Lawson Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: June 10, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 8, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)