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Struvite Stones Antibiotic Study

Sponsor
University of British Columbia (Other)
Overall Status
Recruiting
CT.gov ID
NCT02375295
Collaborator
(none)
28
Enrollment
12
Locations
2
Arms
105
Duration (Months)
2.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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 Names:
  • 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 Names:
  • Keflex, Macrobid, co-trimoxazole

    		•

    Outcome Measures

    Primary Outcome Measures

    1. any recurrent kidney stones [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 [1 year]

      Positive urine cultures at any point within 1 year from surgical therapy.

    2. treated site stone recurrence rates [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 [1 year]

      Antibiotic related complications such as Clostridiuum difficile colitis infections.

    4. ER visit [POD1]

      In hospital sepsis and febrile episodes.

    5. Readmission for sepsis. [3 months]

      Readmission for sepsis.

    6. Readmission for renal colic [3 months]

      Readmission for renal colic

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

      Morbidity or mortality related to sepsis or renal failure

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

      Repeat surgical procedures for stone recurrence

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

      Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic - Scottsdale/Phoenix, AZ Scottsdale Arizona United States 85259
    2 University California San Diego San Diego California United States 92103
    3 Johns Hopkins University Baltimore Maryland United States 21287
    4 Harvard University - Massachusetts General Hospital Boston Massachusetts United States 02114-3117
    5 Mayo Clinic - Rochester, MN Rochester Minnesota United States 55905
    6 Dartmouth University Lebanon New Hampshire United States 03756-0001
    7 New York University New York New York United States 10016
    8 Duke University Durham North Carolina United States 27710
    9 Ohio State University Athens Ohio United States 45701
    10 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    11 Vanderbilt University Nashville Tennessee United States 37235
    12 The Stone Centre, VGH/UBC Vancouver British Columbia Canada V5Z 1M9

    Sponsors and Collaborators

    • University of British Columbia

    Investigators

    • Principal Investigator: Ben Chew, MD, University of British Columbia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ben Chew, MD, Associate Professor, University of British Columbia
    ClinicalTrials.gov Identifier:
    NCT02375295
    Other Study ID Numbers:
    • H13-02514
    First Posted:
    Mar 2, 2015
    Last Update Posted:
    May 17, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Ben Chew, MD, Associate Professor, University of British Columbia
    struvite
    infection
    stones
    calculi
    antibiotics
    Additional relevant MeSH terms:
    Kidney Calculi
    Nephrolithiasis
    Calculi
    Ciprofloxacin
    Trimethoprim, Sulfamethoxazole Drug Combination
    Nitrofurantoin
    Trimethoprim

    Study Results

    No Results Posted as of May 17, 2022