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Antibiotic

Gentamicin Sulfate for Spinal Cord Injury

Phase 2

Waitlist Available

Research Sponsored by University of Louisville

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 change in baseline bladder capacity to post intervention, an average of 5 months.

Awards & highlights

Study Summary

This trial is testing if gentamicin bladder instillations will reduce the rate of UTIs in adults with chronic SCI who have recurrent UTIs.

Eligible Conditions

Spinal Cord Injury
Neurogenic Bladder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in baseline bladder capacity to post intervention, an average of 5 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in baseline bladder capacity to post intervention, an average of 5 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in baseline bladder capacity to post intervention, an average of 5 months. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Evaluate bladder emptying via measurements of voiding efficiency (%) via Urodynamics assessment or uroflow (if appropriate).

Evaluate bladder storage using Urodynamics

Incidence of urinary tract infections measured with Urinalysis and Culture

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: No instillationExperimental Treatment1 Intervention

Participants will be randomized into one of three groups. In this arm participants will not receive an instillation of gentamicin or saline alone, but instead will continue standard of care. Participants will be assessed at the pre-, mid- and post-intervention time points.

Group II: GentamicinExperimental Treatment1 Intervention

Participants will be randomized into one of three groups. In this arm, participants will perform bladder instillations using a 50ml solution of gentamicin mixed with saline, 2 times per day. A formulation derived from 480 mg gentamicin sulfate diluted in 1 L normal saline will be used for instillation. Participants will be blinded during the study and will not know if they are receiving gentamicin or placebo (saline alone).

Group III: Placebo instillation (saline alone)Placebo Group1 Intervention

Participants will be randomized into one of three groups. In this arm, participants will perform bladder instillations using a 50ml solution of saline alone. Participants will be blinded during the study and will not know if they are receiving gentamicin or placebo (saline alone).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gentamicin Sulfate

2017

Completed Phase 2

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

338 Previous Clinical Trials

75,948 Total Patients Enrolled

Frequently Asked Questions

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

What conditions are typically treated with Gentamicin Sulfate?

"Gentamicin Sulfate is commonly employed for treating ocular inflammation, as well as other afflictions such as corneal infection, communicable diseases and sycosis barbae."

Answered by AI

Has Gentamicin Sulfate received clearance from the Food and Drug Administration?

"According to our internal scale, the safety of Gentamicin Sulfate was assessed at a 2. This score is due to this being Phase 2 trial and evidence only existing for its safety but no efficacy data."

Answered by AI

How many participants can join this research endeavor?

"This trial has stopped searching for eligible participants. It was initially posted on February 19th 2019 and last edited March 1st 2022. In case you're seeking out other clinical trials, 1685 studies are presently enrolling patients with spinal cord injuries and 13 research programs require Gentamicin Sulfate test subjects."

Answered by AI

Has Gentamicin Sulfate been utilized in any additional medical examinations?

"At the moment, 13 different clinical trials are running which focus on Gentamicin Sulfate. 5 of these studies have reached Phase 3 and there are 55 sites conducting them across the globe, with many in Louisville, Kentucky."

Answered by AI

Is recruitment still open for this research project?

"The information on clinicaltrials.gov affirms that this particular medical trial is no longer seeking applicants, as the last edit was done on March 1st 2022. Despite being closed for recruitment, there are still 1698 studies actively searching for volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections

April Herrity 2019. "Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03931408.

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