Struvite Stones Antibiotic Study

Last updated: May 16, 2022
Sponsor: University of British Columbia
Overall Status: Active - Recruiting

Phase

4

Condition

Kidney Stones

Treatment

N/A

Clinical Study ID

NCT02375295
H13-02514
  • Ages > 19
  • All Genders

Study Summary

The aim of this research is to determine an effective antibiotic regimen following definitive surgical therapy of kidney stones caused by bacterial infection (struvite stones).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or Female.
  2. No age restriction.
  3. Diagnosed with an infection related stone.
  4. Medically fit for definitive surgical management of stone.
  5. Life expectancy greater than one year.
  6. Stone free after definitive surgical therapy defined as fragments less than 3mm.

Exclusion

Exclusion Criteria:

  1. Patients with medical comorbidities preventing them from definitive surgical therapy.
  2. Patients with persistent stone burden following definitive surgical therapy.

Study Design

Total Participants: 28
Study Start date:
March 01, 2015
Estimated Completion Date:
December 31, 2023

Study Description

Struvite stones or infection stones are a subset of kidney stones that are related to bacterial infection. They only make up 15% of all kidney stones, but account for a much higher percentage of mortality (up to 67%) compared to other stones-due to the infectious component. Treatment is to ensure 100% eradication of the stone with surgery followed by antibiotics to eliminate the infection. Failure to eliminate the bacteria results in the stone growing back quickly. It is unknown how long antibiotics should be administered immediately after surgery-some urologists give 2-4 weeks while others give 2-3 months. We seek to randomize patients to receive 2 weeks of antibiotics or 3 months of antibiotics after surgery to remove all the kidney stones. We will see patients at 3, 6, and 12 months with x-rays and to test their urine for bacterial infections. This is a multi-centre study with participating 12 sites across North America.

Connect with a study center

  • The Stone Centre, VGH/UBC

    Vancouver, British Columbia V5Z 1M9
    Canada

    Active - Recruiting

  • Mayo Clinic - Scottsdale/Phoenix, AZ

    Scottsdale, Arizona 85259
    United States

    Active - Recruiting

  • University California San Diego

    San Diego, California 92103
    United States

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Harvard University - Massachusetts General Hospital

    Boston, Massachusetts 02114-3117
    United States

    Active - Recruiting

  • Mayo Clinic - Rochester, MN

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Dartmouth University

    Lebanon, New Hampshire 03756-0001
    United States

    Active - Recruiting

  • New York University

    New York, New York 10016
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Ohio State University

    Athens, Ohio 45701
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Vanderbilt University

    Nashville, Tennessee 37235
    United States

    Active - Recruiting

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