Clinical trial NCT02375295: Struvite Stones Antibiotic Study
Official title: A Prospective Randomized Trial of 2 Weeks vs 3 Months of Antibiotics Post Percutaneous Nephrolithotomy for the Prevention of Infection-Related Kidney Stones
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Stones
Keywords: struvite
infection
stones
calculi
antibiotics
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: any recurrent kidney stones
timeFrame: 6 months
Secondary outcomes:
measure: UTI
timeFrame: 1 year
measure: treated site stone recurrence rates
timeFrame: 1 year
measure: Clostridiuum difficile colitis
timeFrame: 1 year
measure: ER visit
timeFrame: POD1
measure: Readmission for sepsis.
timeFrame: 3 months
measure: Readmission for renal colic
timeFrame: 3 months
measure: Morbidity or mortality related to sepsis or renal failure
timeFrame: 3 months
measure: Repeat surgical procedures for stone recurrence
timeFrame: 3 months
measure: Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes
timeFrame: 3 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic - Scottsdale/Phoenix, AZ
state: Arizona
city: San Diego
country: United States
facility: University California San Diego
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Harvard University - Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic - Rochester, MN
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth University
state: New Hampshire
city: New York
country: United States
facility: New York University
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Athens
country: United States
facility: Ohio State University
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Vancouver
country: Canada
facility: The Stone Centre, VGH/UBC
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Ben Chew, MD
role: PRINCIPAL_INVESTIGATOR
References: