Using gentamicin to prevent catheter infections
A Randomized Controlled Trial to Evaluate the Effectiveness of Gentamicin Bladder Instillation on CAUTI
This study is testing if using gentamicin to wash out the bladder can help prevent urinary tract infections in hospitalized patients with catheters.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Joseph's Hospital and Medical Center, Phoenix Academic / other |
| Locations | 1 site (Phoenix, Arizona) |
| Trial ID | NCT06332040 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of prophylactic gentamicin bladder irrigation in preventing catheter-associated urinary tract infections (CAUTIs) in hospitalized patients. It is a prospective randomized controlled trial that will involve patients over 18 years old who have an indwelling Foley catheter due to trauma, surgical, or neuro-critical care conditions. The study seeks to address the high incidence of CAUTIs, which are considered preventable but still occur frequently despite existing prevention strategies. By testing this intervention, the trial hopes to provide a new approach to reducing CAUTI rates in critical care settings.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are admitted with trauma, surgical, or neuro-critical care diagnoses and have an indwelling Foley catheter.
Not a fit: Patients with recent urinary infections, traumatic bladder injuries, or allergies to gentamicin will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of CAUTIs, leading to better patient outcomes and lower healthcare costs.
How similar studies have performed: While there have been various approaches to preventing CAUTIs, the specific use of gentamicin bladder irrigation in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age greater than 18 2. admitted with a trauma, surgical, or neuro-critical care diagnosis 3. indwelling foley catheter in place Exclusion Criteria: 1. Documented positive UA or Urine Culture within the past 7 days or upon admission 2. Traumatic bladder injury 3. Gross hematuria 4. Chronic indwelling urethral or chronic suprapubic foley catheter 5. allergy to gentamicin or similar aminoglycosides
Where this trial is running
Phoenix, Arizona
- St. Jpseph's Hospital and Medical Center — Phoenix, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Hahn Soe-Lin, MD — St. Joseph's Hospital and Medical Center, Phoenix
- Study coordinator: Kristina M Kupanoff, PhD
- Email: Kristina.Kupanoff@commonspirit.org
- Phone: 602-406-5192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.