NCT06332040

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
6mo left

Started Oct 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Oct 2023Oct 2026

Study Start

First participant enrolled

October 9, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2026

Last Updated

July 11, 2025

Status Verified

June 1, 2025

Enrollment Period

3 years

First QC Date

March 19, 2024

Last Update Submit

July 8, 2025

Conditions

Catheter Infection

Outcome Measures

Primary Outcomes (1)

  • CAUTI as primary outcome

    positive urine culture

    30 days

Study Arms (2)

Gentamicin

EXPERIMENTAL

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

Drug: Gentamicin

Placebo

PLACEBO COMPARATOR

30 mL of 0.9% saline administered BID

Drug: Gentamicin

Interventions

GentamicinDRUG

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

GentamicinPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age greater than 18
  • admitted with a trauma, surgical, or neuro-critical care diagnosis
  • indwelling foley catheter in place

You may not qualify if:

  • Documented positive UA or Urine Culture within the past 7 days or upon admission
  • Traumatic bladder injury
  • Gross hematuria
  • Chronic indwelling urethral or chronic suprapubic foley catheter
  • allergy to gentamicin or similar aminoglycosides

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jpseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

RECRUITING

MeSH Terms

Interventions

Gentamicins

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Hahn Soe-Lin, MD

    St. Joseph's Hospital and Medical Center, Phoenix

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina M Kupanoff, PhD

CONTACT

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

Hahn Soe-Lin, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2024

First Posted

March 26, 2024

Study Start

October 9, 2023

Primary Completion (Estimated)

October 8, 2026

Study Completion (Estimated)

October 8, 2026

Last Updated

July 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)