Struvite Stones Antibiotic Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2023-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Kidney Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm A: 2 weeks Abx post PCNL

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

Group Type EXPERIMENTAL

ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin

Intervention Type DRUG

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

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).

Group Type ACTIVE_COMPARATOR

ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin

Intervention Type DRUG

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

Interventions

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ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin

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

Intervention Type DRUG

Other Intervention Names

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Keflex, Macrobid, co-trimoxazole

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No