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Antibiotics for Kidney Stones
Phase 4
Waitlist Available
Led By Ben Chew, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to determine the optimal duration for taking antibiotics after surgery for infection-related kidney stones. Patients will take antibiotics for a short or extended period. The goal is to prevent the stones from returning by eliminating the bacteria.
Eligible Conditions
- Kidney Stones
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
any recurrent kidney stones
Secondary study objectives
Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes
Clostridiuum difficile colitis
ER visit
+6 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: 2 weeks Abx post PCNLExperimental Treatment1 Intervention
Oral antibiotics: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin are administered for 2 weeks at full dose.
Group II: Arm B: 12 weeks/3 months Abx post PCNLActive Control1 Intervention
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).
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,466 Previous Clinical Trials
2,485,428 Total Patients Enrolled
13 Trials studying Kidney Stones
4,703 Patients Enrolled for Kidney Stones
Ben Chew, MDPrincipal Investigator - University of British Columbia
University of British Columbia
9 Previous Clinical Trials
976 Total Patients Enrolled
3 Trials studying Kidney Stones
725 Patients Enrolled for Kidney Stones
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for at least one more year.There are no restrictions based on age.You have had surgery to remove kidney stones, and there are no remaining stone pieces larger than 3mm.You have other health conditions that make it unsafe for you to have surgery.You still have kidney stones after having surgery to remove them.You have a stone in your body that is caused by an infection.You are expected to live for at least one more year.There is no age limit for participating in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: 12 weeks/3 months Abx post PCNL
- Group 2: Arm A: 2 weeks Abx post PCNL
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Kidney Stones Patient Testimony for trial: Trial Name: NCT02375295 — Phase 4
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