Gentamicin for Recurrent UTI

Overseen By Julia K Shinnick

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Women and Infants Hospital of Rhode Island

Must not be taking: Antibiotics, Aminoglycosides

Disqualifiers: Parkinsons, Myasthenia gravis, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to prevent recurring urinary tract infections (UTIs) by comparing two treatments. One group will receive gentamicin, an antibiotic placed directly into the bladder, while the other group will take the standard oral antibiotic, nitrofurantoin. Researchers aim to determine if the new method is practical and effective. The trial seeks postmenopausal individuals who have had at least two UTIs in the past six months and wish to try antibiotics to prevent future infections. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, offering participants a chance to contribute to understanding its benefits for more patients.

Will I have to stop taking my current medications?

The trial requires that you have not taken any antibiotics within the last 4 weeks before starting. Other current medications are not specified, so it's best to discuss with the trial team.

What is the safety track record for gentamicin?

Research has shown that administering the antibiotic gentamicin directly into the bladder is safe and well-tolerated. In one study with 63 patients, the number of urinary tract infections dropped significantly, confirming the treatment's safety. Another study supports these findings, demonstrating that gentamicin bladder treatments are effective and safe for individuals with urinary issues. Patients reported positive experiences with this treatment. Additionally, using a single dose of gentamicin for lower urinary tract infections proved effective and had few side effects. Overall, evidence suggests that gentamicin is a safe option for preventing recurring urinary tract infections. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike most treatments for recurrent urinary tract infections (UTIs) that rely on oral antibiotics, gentamicin is unique because it is an aminoglycoside antibiotic with a different mechanism of action, typically administered intravenously or intramuscularly. This distinct method of delivery allows gentamicin to directly target and inhibit bacterial protein synthesis, potentially offering a solution for patients who do not respond well to standard oral antibiotics. Researchers are excited about gentamicin because it may provide an effective alternative for patients with recurrent UTIs, especially where resistance to typical oral antibiotics is a concern.

What evidence suggests that gentamicin might be an effective treatment for recurrent UTI?

Research has shown that using gentamicin directly in the bladder can greatly reduce urinary tract infections (UTIs). In one study, patients experienced a drop in UTIs from 4.8 to just 1.0 per year with this method. Another review found a 75% decrease in UTI rates with gentamicin treatments. Additionally, a comprehensive review showed that 94.5% of patients were free of infection after treatment. These findings suggest that gentamicin, which participants in this trial may receive, effectively prevents recurring UTIs when used this way. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for postmenopausal individuals who've had at least two urinary tract infections (UTIs) in the past six months and are interested in starting antibiotic treatment to prevent future UTIs.

Inclusion Criteria

I have gone through menopause.

I have had 2 urinary tract infections in the last 6 months.

I want to start taking antibiotics to prevent urinary tract infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intravesical gentamicin instillation or oral nitrofurantoin prophylaxis to prevent recurrent UTIs

6 months

Weekly visits for intravesical group, self-reported doses for oral group

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Gentamicin

Trial Overview The study is testing if putting gentamicin directly into the bladder is as good or better than taking nitrofurantoin orally every day to stop recurrent UTIs. It's a feasibility assessment comparing these two approaches.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

Gentamicin

Group II: Standard of Care Active Control 1 Intervention

Standard of care

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials

119

Recruited

59,200+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38860440/

Effectiveness and patient perspective on the use of ... Results: The rate of laboratory proven symptomatic UTI requiring antibiotic treatment decreased from 3.9 to 1.1 infections per year with no ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/nau.25513

Effectiveness and patient perspective on the use of ... A previous retrospective review demonstrated a 75% reduction in the rate of UTI after starting gentamicin instillations compared to before this ...

3. ics.org ics.org/2024/abstract/602

Effectiveness and safety of intravesical gentamicin for ... In a study , a total of 63 patients with recuurent UTI's were included.The mean number of UTIs reduced from 4.8 to 1.0 during intravesical ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6097067/

Use and Effectiveness of Antimicrobial Intravesical Treatment ... Intravesical antimicrobial instillation seems to be a relatively safe and effective method for the prophylaxis and treatment of recurrent UTIs, especially in ...

5. journals.asm.org journals.asm.org/doi/10.1128/aac.02165-18

A Systematic Review of Single-Dose Aminoglycoside Therapy ... The pooled microbiologic cure rate with single-dose aminoglycoside therapy was 94.5% ± 4.3%. Cure was sustained (no recurrence) for 73.4% ± 9.6% of patients at ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557479/

Recurrent Urinary Tract Infections - StatPearls - NCBI Bookshelf Most recurrent UTIs have no long-term sequelae, and patients recover fully. The mortality associated with acute uncomplicated cystitis in women is negligible.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/nau.25635

Is Intravesical Gentamicin the New Gold Standard to ... In our cohort of patients with recurrent and refractory UTIs, intravesical gentamicin instillations has shown to be both safe and effective, ...