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Trial record 93 of 751 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

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

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ClinicalTrials.gov Identifier: NCT01873690
Recruitment Status : Terminated (Due to the low recruitment rate and the large number lost to follow-up)
First Posted : June 10, 2013
Last Update Posted : February 8, 2016
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Hassan Razvi, Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Urolithiasis Drug: Ciprofloxacin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial Assessing the Efficacy of Antimicrobial Prophylaxis for Extracorporeal Shock Wave Lithotripsy on Reducing Urinary Tract Infection
Study Start Date : November 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
5% Dextrose in water

Active Comparator: Ciprofloxacin
Ciprofloxacin
Drug: Ciprofloxacin
Once, 400 mg IV
Other Name: Ciprofloxacin Hydrochloride




Primary Outcome Measures :
  1. Impact of antibiotic prophylaxis on the rate of urinary tract infection [ Time Frame: Post SWL Day 7 ]
    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 :
  1. Bacteriuria post-SWL (≥105 cfu/ml) [ Time Frame: 7-14 days ]
  2. Symptoms of cystitis (new onset burning sensation or pain with voiding, frequency, urgency) [ Time Frame: 7-14 days ]
  3. Pyelonephritis or urosepsis (hospital admission with fever ≥38.5C) [ Time Frame: 7-14 days ]
  4. Change in Urinary Symptom Score(reported as positive or negative integer) [ Time Frame: 7 - 14 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873690


Locations
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Canada, Ontario
St. Joseph's Hospital, St. Joseph's Health Care London
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
The Physicians' Services Incorporated Foundation
Investigators
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Principal Investigator: Hassan Razvi, MD, FRCSC Western University & Lawson Research Institute

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Responsible Party: Hassan Razvi, Principle Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01873690     History of Changes
Other Study ID Numbers: 103696
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hassan Razvi, Lawson Health Research Institute:
Antibiotics
Shock Wave Lithotripsy
Urinary Tract Infection
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Infection
Urinary Tract Infections
Urolithiasis
Urologic Diseases
Ciprofloxacin
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors