Struvite Stones Antibiotic Study

Kidney Stones Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02375295
• Other study ID #: H13-02514
• Status: Recruiting
• Phase: Phase 4
• Start date: March 2015
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: University of British Columbia
• Contact: Olga Arsovska
• Phone: 6048754111
• Email: olga.arsovska[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stones
• Nephrolithiasis

Intervention

Drug:
• ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin
Approved antibiotics used routinely will be given at the physician's discretion with the patient: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin

Locations

Country	Name	City	State
Canada	The Stone Centre, VGH/UBC	Vancouver	British Columbia
United States	Ohio State University	Athens	Ohio
United States	Johns Hopkins University	Baltimore	Maryland
United States	Harvard University - Massachusetts General Hospital	Boston	Massachusetts
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Duke University	Durham	North Carolina
United States	Dartmouth University	Lebanon	New Hampshire
United States	Vanderbilt University	Nashville	Tennessee
United States	New York University	New York	New York
United States	Mayo Clinic - Rochester, MN	Rochester	Minnesota
United States	University California San Diego	San Diego	California
United States	Mayo Clinic - Scottsdale/Phoenix, AZ	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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