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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: 2 weeks Abx post PCNL | Experimental | Oral antibiotics: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin are administered for 2 weeks at full dose. |
|
| Arm B: 12 weeks/3 months Abx post PCNL | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin | Drug | Approved antibiotics used routinely will be given at the physician's discretion with the patient: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olga Arsovska | Contact | 6048754111 | 62421 | olga.arsovska@ubc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Ben Chew, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic - Scottsdale/Phoenix, AZ | Recruiting | Scottsdale | Arizona | 85259 | United States |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D007239 | Infections |
| D002137 | Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| D009582 | Nitrofurantoin |
| D002506 | Cephalexin |
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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|
| 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 |
| University California San Diego | Recruiting | San Diego | California | 92103 | United States |
|
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21287 | United States |
|
| Harvard University - Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114-3117 | United States |
|
| Mayo Clinic - Rochester, MN | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| Dartmouth University | Recruiting | Lebanon | New Hampshire | 03756-0001 | United States |
|
| New York University | Recruiting | New York | New York | 10016 | United States |
|
| Duke University | Recruiting | Durham | North Carolina | 27710 | United States |
|
| Ohio State University | Recruiting | Athens | Ohio | 45701 | United States |
|
| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| Vanderbilt University | Recruiting | Nashville | Tennessee | 37235 | United States |
|
| The Stone Centre, VGH/UBC | Recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |