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Antibiotic Irrigation for Kidney Stones

Phase 2
Waitlist Available
Led By Piruz Motamedinia, M.D.
Research Sponsored by Yale University
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 within 30 days of surgery

Summary

This trial tests if a gentamicin-based fluid can reduce infections after surgery using ureteroscopy.

Who is the study for?
This trial is for adults needing surgery for kidney stones who can consent and follow the study plan. They must have had a positive urine culture treated with antibiotics, use effective contraception, and be at higher risk of post-surgery infection due to past UTIs or complications. Excluded are those with poor kidney function, pregnant or breastfeeding women, allergies to gentamicin, recent IV gentamicin use, or certain ear-related health issues.
What is being tested?
The study tests if using gentamicin in the irrigation fluid during ureteroscopy can lower post-operative infections compared to a placebo. Participants will undergo standard procedures like cystoscopy and possible laser lithotripsy while being monitored for urinary tract infections (UTIs).
What are the potential side effects?
Gentamicin may cause side effects such as allergic reactions in some people. It's also associated with potential risks like kidney damage (nephrotoxicity), hearing loss (ototoxicity), and dizziness but these are closely monitored during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days of surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Symptomatic urinary tract infection
Secondary study objectives
Patient self-reported symptoms
Re-admission to hospital
Urosepsis

Side effects data

From 2013 Phase 4 trial • 614 Patients • NCT00926796
26%
Nausea
17%
Diarrhea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Regimen A: Gentamicin Plus Azithromycin
Regimen B: Gemifloxacin Plus Azithromycin

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Gentamicin-Based IrrigationExperimental Treatment1 Intervention
This group will receive 120 mg of Gentamicin in 3 L NaCl as irrigation fluid during ureteroscopy
Group II: 3 L NaCl IrrigationPlacebo Group1 Intervention
This group will receive the typical NaCl irrigation used during ureteroscopy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gentamicin
2015
Completed Phase 4
~1160

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,046 Total Patients Enrolled
1 Trials studying Urinary Tract Infection
56 Patients Enrolled for Urinary Tract Infection
Piruz Motamedinia, M.D.Principal InvestigatorYale School of Medicine, Department of Urology
~275 spots leftby Oct 2025
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