Struvite Stones Antibiotic Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Stones

Intervention / Treatment
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* Drug: ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female. No age restriction. Diagnosed with an infection related stone. Medically fit for definitive surgical management of stone. Life expectancy greater than one year. Stone free after definitive surgical therapy defined as fragments less than 3mm. Exclusion Criteria: Patients with medical comorbidities preventing them from definitive surgical therapy. Patients with persistent stone burden following definitive surgical therapy.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: 2 weeks Abx post PCNL<br>Oral antibiotics: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin are administered for 2 weeks at full dose. | Drug: ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin<br>* Approved antibiotics used routinely will be given at the physician's discretion with the patient: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin<br>* Other names: Keflex, Macrobid, co-trimoxazole;|
| Active Comparator: Arm B: 12 weeks/3 months Abx post PCNL<br>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<br>* Approved antibiotics used routinely will be given at the physician's discretion with the patient: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin<br>* Other names: Keflex, Macrobid, co-trimoxazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| any recurrent kidney stones | Radiologic recurrence of calculi in the location of original treatment at or before 6 months following definitive surgical therapy. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UTI | Positive urine cultures at any point within 1 year from surgical therapy. | 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 | 1 year | 
| Clostridiuum difficile colitis | Antibiotic related complications such as Clostridiuum difficile colitis infections. | 1 year | 
| ER visit | In hospital sepsis and febrile episodes. | POD1 | 
| Readmission for sepsis. | Readmission for sepsis. | 3 months | 
| Readmission for renal colic | Readmission for renal colic | 3 months | 
| Morbidity or mortality related to sepsis or renal failure | Morbidity or mortality related to sepsis or renal failure | 3 months | 
| Repeat surgical procedures for stone recurrence | Repeat surgical procedures for stone recurrence | 3 months | 
| Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes | Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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struvite, infection, stones, calculi, antibiotics