Struvite Stones Antibiotic Study

Phase 4

• Conditions: Kidney Stones
• Interventions: Drug: ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin

• Registration Number: NCT02375295
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-02-24
• Study Start: 2015-03
• Study First Posted: 2015-03-02
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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.

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Exclusion Criteria

1. Patients with medical comorbidities preventing them from definitive surgical therapy.
2. Patients with persistent stone burden following definitive surgical therapy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B: 12 weeks/3 months Abx post PCNL	ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin	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).
Arm A: 2 weeks Abx post PCNL	ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin	Oral antibiotics: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin are administered for 2 weeks at full dose.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
UTI	1 year	Positive urine cultures at any point within 1 year from surgical therapy.
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.
Readmission for renal colic	3 months	Readmission for renal colic
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

Trial Locations

Locations (12)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Mayo Clinic - Scottsdale/Phoenix, AZ; 🇺🇸 Scottsdale, Arizona, United States

University California San Diego; 🇺🇸 San Diego, California, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Dartmouth University; 🇺🇸 Lebanon, New Hampshire, United States

New York University; 🇺🇸 New York, New York, United States

Mayo Clinic - Rochester, MN; 🇺🇸 Rochester, Minnesota, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

The Stone Centre, VGH/UBC; 🇨🇦 Vancouver, British Columbia, Canada

Harvard University - Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Ohio State University; 🇺🇸 Athens, Ohio, United States