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Struvite Stones Antibiotic Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02375295
Recruitment Status : Unknown
Verified January 2018 by Ben Chew, University of British Columbia.
Recruitment status was:  Recruiting
First Posted : March 2, 2015
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Ben Chew, 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).

Condition or disease Intervention/treatment Phase
Kidney Stones Drug: ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : March 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Arm A: 2 weeks Abx post PCNL
Oral antibiotics: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin are administered for 2 weeks at full dose.
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
Other Name: Keflex, Macrobid, co-trimoxazole

Active Comparator: Arm B: 12 weeks/3 months Abx post PCNL
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).
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
Other Name: Keflex, Macrobid, co-trimoxazole




Primary Outcome Measures :
  1. any recurrent kidney stones [ Time Frame: 6 months ]
    Radiologic recurrence of calculi in the location of original treatment at or before 6 months following definitive surgical therapy.


Secondary Outcome Measures :
  1. UTI [ Time Frame: 1 year ]
    Positive urine cultures at any point within 1 year from surgical therapy.

  2. treated site stone recurrence rates [ Time Frame: 1 year ]
    Radiologic recurrence of calculi in the location of original treatment at or before 12 months following definitive surgical therapy

  3. Clostridiuum difficile colitis [ Time Frame: 1 year ]
    Antibiotic related complications such as Clostridiuum difficile colitis infections.

  4. ER visit [ Time Frame: POD1 ]
    In hospital sepsis and febrile episodes.

  5. Readmission for sepsis. [ Time Frame: 3 months ]
    Readmission for sepsis.

  6. Readmission for renal colic [ Time Frame: 3 months ]
    Readmission for renal colic

  7. Morbidity or mortality related to sepsis or renal failure [ Time Frame: 3 months ]
    Morbidity or mortality related to sepsis or renal failure

  8. Repeat surgical procedures for stone recurrence [ Time Frame: 3 months ]
    Repeat surgical procedures for stone recurrence

  9. Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes [ Time Frame: 3 months ]
    Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375295


Contacts
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Contact: Olga Arsovska 6048754111 ext 62421 olga.arsovska@ubc.ca

Locations
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United States, Arizona
Mayo Clinic - Scottsdale/Phoenix, AZ Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Mitchell Humphreys, MD       Humphreys.Mitchell@mayo.edu   
United States, California
University California San Diego Recruiting
San Diego, California, United States, 92103
Contact: Roger Sur, MD       rlsur@mail.ucsd.edu   
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Brian Matlaga       bmatlag1@jhmi.edu   
United States, Massachusetts
Harvard University - Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114-3117
Contact: Brian Eisner, MD       BEISNER@PARTNERS.ORG   
United States, Minnesota
Mayo Clinic - Rochester, MN Recruiting
Rochester, Minnesota, United States, 55905
Contact: Amy Krambeck, MD       krambeck.amy@mayo.edu   
United States, New Hampshire
Dartmouth University Recruiting
Lebanon, New Hampshire, United States, 03756-0001
Contact: Vernon Pais, MD       Vernon.M.Pais.Jr@hitchcock.org   
United States, New York
New York University Recruiting
New York, New York, United States, 10016
Contact: Ojas Shah, MD       Ojas.Shah@nyumc.org   
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Michael Lipkin, MD       michael.lipkin@duke.edu   
United States, Ohio
Ohio State University Recruiting
Athens, Ohio, United States, 45701
Contact: Bodo Knudsen, MD       Bodo.Knudsen@osumc.edu   
Contact: Janet McGarr       Janet.Mcgarr@osumc.edu   
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Manoj Monga, MD       mongam@ccf.org   
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37235
Contact: Nicole Miller, MD       nicole.miller@Vanderbilt.Edu   
Canada, British Columbia
The Stone Centre, VGH/UBC Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Olga Arsovska    604 875 4111 ext 62421    olga.arsovska@ubc.ca   
Sub-Investigator: Ben Chew, MD         
Principal Investigator: Dirk Lange, PhD         
Sub-Investigator: Ryan Flannigan, MD         
Sub-Investigator: Ryan Paterson, MD         
Sub-Investigator: Elspeth McDougall, MD         
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Ben Chew, MD University of British Columbia

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Responsible Party: Ben Chew, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02375295    
Other Study ID Numbers: H13-02514
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ben Chew, University of British Columbia:
struvite
infection
stones
calculi
antibiotics
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Anti-Bacterial Agents
Ciprofloxacin
Trimethoprim, Sulfamethoxazole Drug Combination
Nitrofurantoin
Antibiotics, Antitubercular
Trimethoprim
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Anti-Dyskinesia Agents