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UnknownNCT02375295

Struvite Stones Antibiotic Study

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

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
28 (estimated)
Sponsor
University of British Columbia · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

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).

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.

Conditions

Interventions

TypeNameDescription
DRUGciprofloxacin, cotrimoxazole-trimethoprim, macrodantinApproved antibiotics used routinely will be given at the physician's discretion with the patient: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin

Timeline

Start date
2015-03-01
Primary completion
2023-12-01
Completion
2023-12-01
First posted
2015-03-02
Last updated
2022-05-17

Locations

12 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT02375295. Inclusion in this directory is not an endorsement.