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Aminoglycoside Antibiotic

Gentamicin for Urinary Tract Infection

Phase 4
Waitlist Available
Led By Sean P Elliott, MD, MS, FACS
Research Sponsored by Gillette Children's Specialty Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Approved for 10 Other Conditions
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved

Summary

Recurrent UTIs are common among patients on IC. These create significant patient morbidity and healthcare burden. In desperation, many physicians prescribe prophylactic oral or intravesical antibiotics. This practice is common among our Gillette clinic patients. However, the benefit is unclear and the risks are not insignificant. As such, practice variation is significant. In order to better define the evidence for or against gentamicin bladder irrigation and thus inform clinical practice both locally at our Gillette urology clinic and for practitioners at large we will pursue the following specific aims: 1. Compare rates of symptomatic urinary tract infection and asymptomatic bacteriuria among a population of Gillette patients on IC with and without gentamicin bladder instillation. 2. Compare antibiotic resistance rates among a population of Gillette patients on IC with and without gentamicin bladder instillation.

Eligible Conditions
  • Urinary Tract Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year 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 UTI
Secondary study objectives
Asymptomatic UTI

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

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: GentamicinExperimental Treatment1 Intervention
Intervention: Gentamicin; Dosage form: 120mg reconstituted in 250cc of normal saline; Dosage: 30mL; Frequency: nightly instillation into bladder (to remain overnight until draining it out in morning); Duration: 1 year
Group II: PlaceboPlacebo Group1 Intervention
Drug: Normal saline; Dosage form: N/A; Dosage: 30 mL; Frequency: nightly bladder instillation; Duration: 1 year
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gentamicin
FDA approved

Find a Location

Who is running the clinical trial?

Gillette Children's Specialty HealthcareLead Sponsor
30 Previous Clinical Trials
8,047 Total Patients Enrolled
Sean P Elliott, MD, MS, FACSPrincipal InvestigatorGillette Children's Specialty Healthcare
~2 spots leftby Dec 2025