Recruiting

Struvite Stones

Sponsor:

University of British Columbia

Code:

NCT02375295

Conditions

Kidney Stones

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin

Study Details

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).

Conditions

Kidney Stones

Study ID

NCT02375295

Start date

Mar, 2015

Status verified date

May, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Arm A: 2 weeks Abx post PCNL

Oral antibiotics: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin are administered for 2 weeks at full dose.

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).

Interventions

ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin

Approved antibiotics used routinely will be given at the physician's discretion with the patient: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin

Primary outcome measure

  • any recurrent kidney stones [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Olga Arsovska

6048754111olga.arsovska@ubc.ca

Locations

Mayo Clinic - Scottsdale/Phoenix, AZ

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Mitchell Humphreys, MD

Humphreys.Mitchell@mayo.edu

University California San Diego

Recruiting

San Diego, California, United States, 92103

Contacts

Roger Sur, MD

rlsur@mail.ucsd.edu

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Brian Matlaga

bmatlag1@jhmi.edu

Harvard University - Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114-3117

Contacts

Brian Eisner, MD

BEISNER@PARTNERS.ORG

Mayo Clinic - Rochester, MN

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Amy Krambeck, MD

krambeck.amy@mayo.edu

Dartmouth University

Recruiting

Lebanon, New Hampshire, United States, 03756-0001

Contacts

Vernon Pais, MD

Vernon.M.Pais.Jr@hitchcock.org

New York University

Recruiting

New York, New York, United States, 10016

Contacts

Ojas Shah, MD

Ojas.Shah@nyumc.org

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Michael Lipkin, MD

michael.lipkin@duke.edu

Ohio State University

Recruiting

Athens, Ohio, United States, 45701

Contacts

Bodo Knudsen, MD

Bodo.Knudsen@osumc.edu

Janet McGarr

Janet.Mcgarr@osumc.edu

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Manoj Monga, MD

mongam@ccf.org

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37235

Contacts

Nicole Miller, MD

nicole.miller@Vanderbilt.Edu

The Stone Centre, VGH/UBC

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Olga Arsovska

604 875 4111olga.arsovska@ubc.ca

Principal Investigator:

Dirk Lange, PhD

More Information

Sponsor

University of British Columbia

Last update posted

May 17, 2022

Last verified

May, 2022

Keywords

  • struvite
  • infection
  • stones
  • calculi
  • antibiotics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of British Columbia on 2022-05-17.