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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02375295
Other study ID # H13-02514
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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