Summary

for people ages 19 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

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).

Official Title

A Prospective Randomized Trial of 2 Weeks vs 3 Months of Antibiotics Post Percutaneous Nephrolithotomy for the Prevention of Infection-Related Kidney Stones

Details

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.

Keywords

Kidney Stones struvite infection stones calculi antibiotics Kidney Calculi Nephrolithiasis Anti-Bacterial Agents Ciprofloxacin Trimethoprim, Sulfamethoxazole Drug Combination Antibiotics, Antitubercular Trimethoprim Nitrofurantoin ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin

Eligibility

You can join if…

Open to people ages 19 years and up

  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.

You CAN'T join if...

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

Locations

  • University California San Diego accepting new patients
    San Diego California 92103 United States
  • Mayo Clinic - Scottsdale/Phoenix, AZ accepting new patients
    Scottsdale Arizona 85259 United States
  • The Stone Centre, VGH/UBC accepting new patients
    Vancouver British Columbia V5Z 1M9 Canada

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of British Columbia
ID
NCT02375295
Phase
Phase 4
Study Type
Interventional
Last Updated
January 2, 2018