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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 19 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Criteria

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: 2 weeks Abx post PCNL 		Oral antibiotics: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin are administered for 2 weeks at full dose.
  • Drug: ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin
    Approved antibiotics used routinely will be given at the physician's discretion with the patient: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin
    Other names:
    • Keflex, Macrobid, co-trimoxazole
Active Comparator
Arm B: 12 weeks/3 months Abx post PCNL 		Oral antibiotics: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin are administered for 2 weeks at full dose followed by a suppressive dose for another 10 weeks (total = 12 weeks or 3 months).
  • Drug: ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin
    Approved antibiotics used routinely will be given at the physician's discretion with the patient: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin
    Other names:
    • Keflex, Macrobid, co-trimoxazole

Recruiting Locations

Harvard University - Massachusetts General Hospital
Boston, Massachusetts 02114-3117
Contact:
Brian Eisner, MD
BEISNER@PARTNERS.ORG

More Details

Status
Recruiting
Sponsor
University of British Columbia

Study Contact

Olga Arsovska
6048754111
olga.arsovska@ubc.ca

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.