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Anti-bacterial

Gentamicin for Catheter-Associated Infections

Phase 4
Recruiting
Led By Hahn Soe-Lin, MD
Research Sponsored by St. Joseph's Hospital and Medical Center, Phoenix
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 30 days
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

"This trial aims to test if using a specific antibiotic solution in the bladder can help prevent urinary tract infections in patients with catheters. Urinary tract infections in these patients are considered a serious complication, but

Who is the study for?
This trial is for adults over 18 who are admitted with trauma, surgical, or neuro-critical care issues and have a temporary urinary catheter. It's not for those with chronic catheters, bladder injuries, recent urine infections, or allergies to gentamicin or similar antibiotics.
What is being tested?
The study is testing if rinsing the bladder with Gentamicin can prevent urinary tract infections in patients with catheters. Participants will be randomly chosen to receive either the Gentamicin rinse or no rinse as a control group.
What are the potential side effects?
Gentamicin may cause side effects such as kidney problems, hearing loss, dizziness, and could lead to nerve damage. These are more common when taken by injection but might occur with bladder irrigation too.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CAUTI as

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

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
14.4 mg gentamicin dissolved in 30 mL 0f 0.9% saline administered BID
Group II: PlaceboPlacebo Group1 Intervention
30 mL of 0.9% saline administered BID
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?

St. Joseph's Hospital and Medical Center, PhoenixLead Sponsor
67 Previous Clinical Trials
16,964 Total Patients Enrolled
Hahn Soe-Lin, MDPrincipal InvestigatorSt. Joseph's Hospital and Medical Center, Phoenix
~251 spots leftby Oct 2026
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