Struvite Stones Antibiotic Study
Primary Purpose
Kidney Stones
Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Stones focused on measuring struvite, infection, stones, calculi, antibiotics
Eligibility Criteria
Inclusion Criteria:
- Male or Female.
- No age restriction.
- Diagnosed with an infection related stone.
- Medically fit for definitive surgical management of stone.
- Life expectancy greater than one year.
- Stone free after definitive surgical therapy defined as fragments less than 3mm.
Exclusion Criteria:
- Patients with medical comorbidities preventing them from definitive surgical therapy.
- Patients with persistent stone burden following definitive surgical therapy.
Sites / Locations
- Mayo Clinic - Scottsdale/Phoenix, AZRecruiting
- University California San DiegoRecruiting
- Johns Hopkins UniversityRecruiting
- Harvard University - Massachusetts General HospitalRecruiting
- Mayo Clinic - Rochester, MNRecruiting
- Dartmouth UniversityRecruiting
- New York UniversityRecruiting
- Duke UniversityRecruiting
- Ohio State UniversityRecruiting
- Cleveland Clinic FoundationRecruiting
- Vanderbilt UniversityRecruiting
- The Stone Centre, VGH/UBCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A: 2 weeks Abx post PCNL
Arm B: 12 weeks/3 months Abx post PCNL
Arm Description
Oral antibiotics: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin are administered for 2 weeks at full dose.
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).
Outcomes
Primary Outcome Measures
any recurrent kidney stones
Radiologic recurrence of calculi in the location of original treatment at or before 6 months following definitive surgical therapy.
Secondary Outcome Measures
UTI
Positive urine cultures at any point within 1 year from surgical therapy.
treated site stone recurrence rates
Radiologic recurrence of calculi in the location of original treatment at or before 12 months following definitive surgical therapy
Clostridiuum difficile colitis
Antibiotic related complications such as Clostridiuum difficile colitis infections.
ER visit
In hospital sepsis and febrile episodes.
Readmission for sepsis.
Readmission for sepsis.
Readmission for renal colic
Readmission for renal colic
Morbidity or mortality related to sepsis or renal failure
Morbidity or mortality related to sepsis or renal failure
Repeat surgical procedures for stone recurrence
Repeat surgical procedures for stone recurrence
Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes
Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes
Full Information
NCT ID
NCT02375295
First Posted
February 24, 2015
Last Updated
May 16, 2022
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02375295
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones
Keywords
struvite, infection, stones, calculi, antibiotics
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A: 2 weeks Abx post PCNL
Arm Type
Experimental
Arm Description
Oral antibiotics: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin are administered for 2 weeks at full dose.
Arm Title
Arm B: 12 weeks/3 months Abx post PCNL
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin
Other Intervention Name(s)
Keflex, Macrobid, co-trimoxazole
Intervention Description
Approved antibiotics used routinely will be given at the physician's discretion with the patient: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin
Primary Outcome Measure Information:
Title
any recurrent kidney stones
Description
Radiologic recurrence of calculi in the location of original treatment at or before 6 months following definitive surgical therapy.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
UTI
Description
Positive urine cultures at any point within 1 year from surgical therapy.
Time Frame
1 year
Title
treated site stone recurrence rates
Description
Radiologic recurrence of calculi in the location of original treatment at or before 12 months following definitive surgical therapy
Time Frame
1 year
Title
Clostridiuum difficile colitis
Description
Antibiotic related complications such as Clostridiuum difficile colitis infections.
Time Frame
1 year
Title
ER visit
Description
In hospital sepsis and febrile episodes.
Time Frame
POD1
Title
Readmission for sepsis.
Description
Readmission for sepsis.
Time Frame
3 months
Title
Readmission for renal colic
Description
Readmission for renal colic
Time Frame
3 months
Title
Morbidity or mortality related to sepsis or renal failure
Description
Morbidity or mortality related to sepsis or renal failure
Time Frame
3 months
Title
Repeat surgical procedures for stone recurrence
Description
Repeat surgical procedures for stone recurrence
Time Frame
3 months
Title
Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes
Description
Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female.
No age restriction.
Diagnosed with an infection related stone.
Medically fit for definitive surgical management of stone.
Life expectancy greater than one year.
Stone free after definitive surgical therapy defined as fragments less than 3mm.
Exclusion Criteria:
Patients with medical comorbidities preventing them from definitive surgical therapy.
Patients with persistent stone burden following definitive surgical therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olga Arsovska
Phone
6048754111
Ext
62421
Email
olga.arsovska@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Chew, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic - Scottsdale/Phoenix, AZ
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitchell Humphreys, MD
Email
Humphreys.Mitchell@mayo.edu
Facility Name
University California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger Sur, MD
Email
rlsur@mail.ucsd.edu
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Matlaga
Email
bmatlag1@jhmi.edu
Facility Name
Harvard University - Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-3117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Eisner, MD
Email
BEISNER@PARTNERS.ORG
Facility Name
Mayo Clinic - Rochester, MN
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Krambeck, MD
Email
krambeck.amy@mayo.edu
Facility Name
Dartmouth University
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vernon Pais, MD
Email
Vernon.M.Pais.Jr@hitchcock.org
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ojas Shah, MD
Email
Ojas.Shah@nyumc.org
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Lipkin, MD
Email
michael.lipkin@duke.edu
Facility Name
Ohio State University
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bodo Knudsen, MD
Email
Bodo.Knudsen@osumc.edu
First Name & Middle Initial & Last Name & Degree
Janet McGarr
Email
Janet.Mcgarr@osumc.edu
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manoj Monga, MD
Email
mongam@ccf.org
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Miller, MD
Email
nicole.miller@Vanderbilt.Edu
Facility Name
The Stone Centre, VGH/UBC
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Arsovska
Phone
604 875 4111
Ext
62421
Email
olga.arsovska@ubc.ca
First Name & Middle Initial & Last Name & Degree
Ben Chew, MD
First Name & Middle Initial & Last Name & Degree
Dirk Lange, PhD
First Name & Middle Initial & Last Name & Degree
Ryan Flannigan, MD
First Name & Middle Initial & Last Name & Degree
Ryan Paterson, MD
First Name & Middle Initial & Last Name & Degree
Elspeth McDougall, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Struvite Stones Antibiotic Study
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