Gentamicin Bladder Instillation on CAUTI

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Study ID
NCT06332040
Phase
PHASE4
Status
Recruiting
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Conditions

  • Catheter Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 9, 2023
Status verified
Jun 2025
Primary completion
Oct 8, 2026
Completion
Oct 8, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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

Primary Outcome Measure

CAUTI as primary outcome [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jpseph's Hospital and Medical CenterPhoenixArizona85013
Kristina Kupanoff, PhD
[email protected]
602-406-5192

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