Kidney Stones
Conditions
Keywords
struvite, infection, stones, calculi, antibiotics
Brief 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.
Interventions
DRUGciprofloxacin, cotrimoxazole-trimethoprim, macrodantin
Approved antibiotics used routinely will be given at the physician's discretion with the patient: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| any recurrent kidney stones | 6 months | Radiologic recurrence of calculi in the location of original treatment at or before 6 months following definitive surgical therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| treated site stone recurrence rates | 1 year | Radiologic recurrence of calculi in the location of original treatment at or before 12 months following definitive surgical therapy |
| Clostridiuum difficile colitis | 1 year | Antibiotic related complications such as Clostridiuum difficile colitis infections. |
| ER visit | POD1 | In hospital sepsis and febrile episodes. |
| Readmission for sepsis. | 3 months | Readmission for sepsis. |
| UTI | 1 year | Positive urine cultures at any point within 1 year from surgical therapy. |
| Morbidity or mortality related to sepsis or renal failure | 3 months | Morbidity or mortality related to sepsis or renal failure |
| Repeat surgical procedures for stone recurrence | 3 months | Repeat surgical procedures for stone recurrence |
| Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes | 3 months | Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes |
| Readmission for renal colic | 3 months | Readmission for renal colic |
Countries
Canada, United States
Contacts
Primary ContactOlga Arsovska
Outcome results
None listed