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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.

Summary

This trial tests if placing an antibiotic solution directly into the bladder can reduce infections in adults with spinal cord injuries who frequently get UTIs. The goal is to see if this method lowers the need for other antibiotics.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Side effects data

From 2023 Phase 2 & 3 trial • 23 Patients • NCT03503513

63%

Urinary Tract Infection

21%

COVID-19

16%

flu-like symptoms

16%

bladder spasms

11%

Clinically significant labs

11%

abdominal stoma issue

11%

GI upset

11%

heel wound

upper respiratory infection

bowel obstruction

Serratia tissue infection

loose stool

hematuria

inguinal pain

parotitis

vaginitis

muscle strain

Gross hematuria

nasal discharge

bladder stone

bone infection

bladder irritation

bleeding from catheter site

pneumonia

conjunctivitis

sweating

urinary discharge

pulmonary embolism

Post-COVID 19 pneumonia

cystolitholapaxy

Renal stone removal

air in bladder

100%

80%

60%

40%

20%

Study treatment Arm

Gentamicin Sulfate

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

2018

Completed Phase 3

~4430

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