Struvite Stones Antibiotic Study

NCT02375295 | Unknown Phase 4

• 1 other identifier: H13-02514
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 12

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

Keywords

struvite; infection; stones; calculi; antibiotics

Outcome Measures

Primary Outcomes (1)

• any recurrent kidney stones

  Radiologic recurrence of calculi in the location of original treatment at or before 6 months following definitive surgical therapy.

  6 months

Secondary Outcomes (9)

• UTI

  1 year

• treated site stone recurrence rates

  1 year

• Clostridiuum difficile colitis

  1 year

• ER visit

  POD1

• Readmission for sepsis.

  3 months

Study Arms (2)

Arm A: 2 weeks Abx post PCNL

EXPERIMENTAL

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

Drug: ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin

Arm B: 12 weeks/3 months Abx post PCNL

ACTIVE COMPARATOR

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

Interventions

ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin DRUG

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

Also known as: Keflex, Macrobid, co-trimoxazole

Arm A: 2 weeks Abx post PCNL; Arm B: 12 weeks/3 months Abx post PCNL

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with medical comorbidities preventing them from definitive surgical therapy.
• Patients with persistent stone burden following definitive surgical therapy.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (12)

Mayo Clinic - Scottsdale/Phoenix, AZ

Scottsdale, Arizona, 85259, United States

RECRUITING

University California San Diego

San Diego, California, 92103, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Harvard University - Massachusetts General Hospital

Boston, Massachusetts, 02114-3117, United States

RECRUITING

Mayo Clinic - Rochester, MN

Rochester, Minnesota, 55905, United States

RECRUITING

Dartmouth University

Lebanon, New Hampshire, 03756-0001, United States

RECRUITING

New York University

New York, New York, 10016, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Ohio State University

Athens, Ohio, 45701, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37235, United States

RECRUITING

The Stone Centre, VGH/UBC

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

MeSH Terms

Conditions

Kidney Calculi; Infections; Calculi

Interventions

Ciprofloxacin; Nitrofurantoin; Cephalexin; Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitrofurans; Nitro Compounds; Organic Chemicals; Furans; Heterocyclic Compounds, 1-Ring; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Trimethoprim; Pyrimidines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Ben Chew, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Arsovska

CONTACT

6048754111; olga.arsovska@ubc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 2, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (11); CA (1)