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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CAUTI as

Side effects data

From 2013 Phase 4 trial • 614 Patients • NCT00926796

40%

Nausea

22%

Diarrhea

14%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Regimen B: Gemifloxacin Plus Azithromycin

Regimen A: Gentamicin Plus Azithromycin

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

~1110

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

St. Joseph's Hospital and Medical Center, PhoenixLead Sponsor

63 Previous Clinical Trials

14,217 Total Patients Enrolled

Hahn Soe-Lin, MDPrincipal InvestigatorSt. Joseph's Hospital and Medical Center, Phoenix

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase currently open for this clinical trial?

"Per information from clinicaltrials.gov, this investigation is presently enrolling participants. The trial was made public on October 9th, 2023, and its most recent update occurred on March 19th, 2024."

Answered by AI

Has Gentamicin been officially sanctioned by the FDA for use in patients?

"According to the assessment by our team at Power, Gentamicin's safety level is rated as 3 due to its Phase 4 trial status, signifying regulatory approval for this treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gentamicin Bladder Instillation on CAUTI

2023. "Gentamicin Bladder Instillation on CAUTI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06332040.

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