Recruiting

Gentamicin

Sponsor:

St. Joseph's Hospital and Medical Center, Phoenix

Code:

NCT06332040

Conditions

Catheter Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gentamicin

Study Details

Brief summary:

Urinary tract infections in catheterized patients is an unacceptable complication and has been termed a 'never event' by the Center for Medicare \& Medicaid Services (CMS); however there is not consensus among clinicians on how to best prevent CAUTIs. We propose a prospective randomized controlled trial to test the efficacy of prophylactic gentamicin bladder irrigation in elimination of CAUTIs.

Conditions

Catheter Infection

Study ID

NCT06332040

Start date

Oct 9, 2023

Status verified date

Jun, 2025

Completion date

Oct 8, 2026

Anticipated

Primary completion date

Oct 8, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Gentamicin

14.4 mg gentamicin dissolved in 30 mL 0f 0.9% saline administered BID

placebo comparator: Placebo

30 mL of 0.9% saline administered BID

Interventions

Gentamicin

random assignment to gentamicin or placebo bladder instillation to prevent CAUTI (catheterized urinary track infection)

Primary outcome measure

  • CAUTI as primary outcome [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Kristina M Kupanoff, PhD

602-406-5192Kristina.Kupanoff@commonspirit.org

Hahn Soe-Lin, MD

602-406-3874Hahn.Soe-Lin@commonspirit.org

Locations

St. Jpseph's Hospital and Medical Center

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Kristina Kupanoff, PhD

602-406-5192Kristina.Kupanoff@Commonspirit.org

More Information

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Last update posted

Jul 11, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by St. Joseph's Hospital and Medical Center, Phoenix on 2025-07-11.