Kidney StonesPhase 4NCT02375295
Struvite Stones Antibiotic Study
A Phase 4 study testing ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin in people with Kidney Stones, run by University of British Columbia at 12 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Kidney Stones
- What is being tested?
- ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Mar 2015to Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with medical comorbidities preventing them from definitive surgical therapy.
- Patients with persistent stone burden following definitive surgical therapy.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites, 11 recruiting
- Recruiting
Ohio State University
Athens, Ohio, 45701
Bodo Knudsen, MD, Bodo.Knudsen@osumc.edu
Janet McGarr, Janet.Mcgarr@osumc.edu
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Brian Matlaga, bmatlag1@jhmi.edu
- Recruiting
Harvard University - Massachusetts General Hospital
Boston, Massachusetts, 02114-3117
Brian Eisner, MD, BEISNER@PARTNERS.ORG
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Manoj Monga, MD, mongam@ccf.org
- Recruiting
Duke University
Durham, North Carolina, 27710
Michael Lipkin, MD, michael.lipkin@duke.edu
- Recruiting
Dartmouth University
Lebanon, New Hampshire, 03756-0001
Vernon Pais, MD, Vernon.M.Pais.Jr@hitchcock.org
- Recruiting
Vanderbilt University
Nashville, Tennessee, 37235
Nicole Miller, MD, nicole.miller@Vanderbilt.Edu
- Recruiting
New York University
New York, New York, 10016
Ojas Shah, MD, Ojas.Shah@nyumc.org
- Recruiting
Mayo Clinic - Rochester, MN
Rochester, Minnesota, 55905
Amy Krambeck, MD, krambeck.amy@mayo.edu
- Recruiting
University California San Diego
San Diego, California, 92103
Roger Sur, MD, rlsur@mail.ucsd.edu
- Recruiting
Mayo Clinic - Scottsdale/Phoenix, AZ
Scottsdale, Arizona, 85259
Mitchell Humphreys, MD, Humphreys.Mitchell@mayo.edu
Canada1 site, 1 recruiting
- Recruiting
The Stone Centre, VGH/UBC
Vancouver, British Columbia, V5Z 1M9
Olga Arsovska, 604 875 4111 ext. 62421, olga.arsovska@ubc.ca
Ben Chew, MD
About this study
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
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).
Read the 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.
- Conditions
- Kidney Stones
- Being tested
- ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin
- Keywords
- struvite, infection, stones, calculi, antibiotics
- Medical subject headings
- Kidney Calculi, Infections, Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciprofloxacin, cotrimoxazole-trimethoprim, macrodantinDrug
Also called Keflex, Macrobid, co-trimoxazole
Approved antibiotics used routinely will be given at the physician's discretion with the patient: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin
| Study group | Role | What they receive |
|---|---|---|
| Arm A: 2 weeks Abx post PCNL | Experimental | Oral antibiotics: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin are administered for 2 weeks at full dose. Receives: 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). Receives: Drug: ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin |
What is being measured
The primary outcome is the main question the study is designed to answer.
any recurrent kidney stones
Radiologic recurrence of calculi in the location of original treatment at or before 6 months following definitive surgical therapy.
Measured: 6 months
Secondary outcomes (9)
UTI
Positive urine cultures at any point within 1 year from surgical therapy.
Measured: 1 year
treated site stone recurrence rates
Radiologic recurrence of calculi in the location of original treatment at or before 12 months following definitive surgical therapy
Measured: 1 year
Clostridiuum difficile colitis
Antibiotic related complications such as Clostridiuum difficile colitis infections.
Measured: 1 year
ER visit
In hospital sepsis and febrile episodes.
Measured: POD1
Readmission for sepsis.
Readmission for sepsis.
Measured: 3 months
Readmission for renal colic
Readmission for renal colic
Measured: 3 months
Morbidity or mortality related to sepsis or renal failure
Morbidity or mortality related to sepsis or renal failure
Measured: 3 months
Repeat surgical procedures for stone recurrence
Repeat surgical procedures for stone recurrence
Measured: 3 months
Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes
Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Chew, MD, University of British Columbia
- Investigators
- Ben Chew, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375295
- Sponsor's protocol ID
- H13-02514
- Status last verified
- May 2022
- First submitted
- 24 Feb 2015
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02375295
- Acronym / sponsor ID
- H13-02514
- Conditions
- Kidney Stones
- Keywords
- struvite, infection, stones, calculi, antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: 2 weeks Abx post PCNL | Experimental | Drug: ciprofloxacin, cotrimoxazole-trimethoprim, macrodantinOral antibiotics: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin are administered for 2 weeks at full dose. |
| Arm B: 12 weeks/3 months Abx post PCNL | Active comparator | Drug: ciprofloxacin, cotrimoxazole-trimethoprim, macrodantinOral 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). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with medical comorbidities preventing them from definitive surgical therapy.
- Patients with persistent stone burden following definitive surgical therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ciprofloxacin, cotrimoxazole-trimethoprim, macrodantinAlso: Keflex, Macrobid, co-trimoxazoleApproved antibiotics used routinely will be given at the physician's discretion with the patient: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin | Drug | Arm A: 2 weeks Abx post PCNL, Arm B: 12 weeks/3 months Abx post PCNL |
Primary outcome
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.
9 secondary outcomes
UTI
Time frame: 1 year
treated site stone recurrence rates
Time frame: 1 year
Clostridiuum difficile colitis
Time frame: 1 year
ER visit
Time frame: POD1
Readmission for sepsis.
Time frame: 3 months
Readmission for renal colic
Time frame: 3 months
Morbidity or mortality related to sepsis or renal failure
Time frame: 3 months
Repeat surgical procedures for stone recurrence
Time frame: 3 months
Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Chew, MD principal investigator
University of British Columbia
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin in people with Kidney Stones, run by University of British Columbia at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olga Arsovska (6048754111 ext. 62421, olga.arsovska@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
any recurrent kidney stones (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.