Struvite Stones Antibiotic Study

May 16, 2022 updated by: Ben Chew, MD, University of British Columbia

A Prospective Randomized Trial of 2 Weeks vs 3 Months of Antibiotics Post Percutaneous Nephrolithotomy for the Prevention of Infection-Related Kidney Stones

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • The Stone Centre, VGH/UBC
        • Sub-Investigator:
          • Ryan Flannigan, MD
        • Sub-Investigator:
          • Ryan Paterson, MD
        • Contact:
        • Sub-Investigator:
          • Ben Chew, MD
        • Principal Investigator:
          • Dirk Lange, PhD
        • Sub-Investigator:
          • Elspeth McDougall, MD
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
    • California
      • San Diego, California, United States, 92103
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114-3117
        • Recruiting
        • Harvard University - Massachusetts General Hospital
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • New Hampshire
    • New York
      • New York, New York, United States, 10016
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Athens, Ohio, United States, 45701
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UTI
Time Frame: 1 year
Positive urine cultures at any point within 1 year from surgical therapy.
1 year
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
1 year
Clostridiuum difficile colitis
Time Frame: 1 year
Antibiotic related complications such as Clostridiuum difficile colitis infections.
1 year
ER visit
Time Frame: POD1
In hospital sepsis and febrile episodes.
POD1
Readmission for sepsis.
Time Frame: 3 months
Readmission for sepsis.
3 months
Readmission for renal colic
Time Frame: 3 months
Readmission for renal colic
3 months
Morbidity or mortality related to sepsis or renal failure
Time Frame: 3 months
Morbidity or mortality related to sepsis or renal failure
3 months
Repeat surgical procedures for stone recurrence
Time Frame: 3 months
Repeat surgical procedures for stone recurrence
3 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

March 2, 2015

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H13-02514

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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