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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
28
Approved antibiotics used routinely will be given at the physician's discretion with the patient: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin
Mayo Clinic - Scottsdale/Phoenix, AZ
Scottsdale, Arizona, United States
RECRUITINGUniversity California San Diego
San Diego, California, United States
any recurrent kidney stones
Radiologic recurrence of calculi in the location of original treatment at or before 6 months following definitive surgical therapy.
Time frame: 6 months
UTI
Positive urine cultures at any point within 1 year from surgical therapy.
Time frame: 1 year
treated site stone recurrence rates
Radiologic recurrence of calculi in the location of original treatment at or before 12 months following definitive surgical therapy
Time frame: 1 year
Clostridiuum difficile colitis
Antibiotic related complications such as Clostridiuum difficile colitis infections.
Time frame: 1 year
ER visit
In hospital sepsis and febrile episodes.
Time frame: POD1
Readmission for sepsis.
Readmission for sepsis.
Time frame: 3 months
Readmission for renal colic
Readmission for renal colic
Time frame: 3 months
Morbidity or mortality related to sepsis or renal failure
Morbidity or mortality related to sepsis or renal failure
Time frame: 3 months
Repeat surgical procedures for stone recurrence
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Johns Hopkins University
Baltimore, Maryland, United States
RECRUITINGHarvard University - Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGMayo Clinic - Rochester, MN
Rochester, Minnesota, United States
RECRUITINGDartmouth University
Lebanon, New Hampshire, United States
RECRUITINGNew York University
New York, New York, United States
RECRUITINGDuke University
Durham, North Carolina, United States
RECRUITINGOhio State University
Athens, Ohio, United States
RECRUITINGCleveland Clinic Foundation
Cleveland, Ohio, United States
RECRUITING...and 2 more locations
Repeat surgical procedures for stone recurrence
Time frame: 3 months
Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes
Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes
Time frame: 3 months