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Catheter InfectionPhase 4NCT06332040

Gentamicin Bladder Instillation on CAUTI

A Phase 4 study testing Gentamicin in people with Catheter Infection, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Catheter Infection
What is being tested?
Gentamicin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
400 participants
Where
1 siteUnited States
Study dates
9 Oct 2023to 8 Oct 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • St. Jpseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

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

    Recruiting

Other trials in United States

About this study

Official title: A Randomized Controlled Trial to Evaluate the Effectiveness of Gentamicin Bladder Instillation on CAUTI

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.

Read the detailed description

Catheter Associated Urinary Tract Infection (CAUTI) is a hospital acquired infection considered preventable by the Center for Medicare \& Medicaid Services (CMS) and originally estimated to cost each individual patient approximately $4700 per infection in 2009 US dollars1. In the inpatient population, more contemporary calculations have associated the per patient cost to have risen to a mean of $13,793 per patient (range $4,694-$29,743)2, with an increased median length of stay of 3.6 days, and a 1.37 increased odds ratio of death3.

CMS understandably has declared CAUTI a "never event", a term coined by the National Quality Forum and used to describe preventable hospital acquired infections4. Since 2008 they have tied this quality metric to severe hospital payment penalties to incentivize prioritization of strategies to decrease CAUTIs.

Despite considerable efforts to remain in compliance with this guidance, and hospitals nationwide implementing safer catheter placement training as well as aggressive early catheter removal protocols, it has become clear that CAUTIs are almost never a never event5. Quantitative analyses of these events have estimated that only 65-70% of CAUTIs are truly preventable with current evidence-based prevention strategies6.

In our intensive care units the pragmatic reasons explaining this phenomenon are abundantly clear. Trauma patients critically injured with multiple spinal, pelvic and long bone fractures, intubated on a ventilator and immobile have substantially higher rates of urine retention when foley catheters are removed aggressively within 72 hours of admission per current infection control protocols. Similarly, neuro critical care patients who incurred a massive stroke or traumatic brain injury who are immobilized from their disabilities do not routinely succeed with early catheter removal protocols. Replacing indwelling foley catheters after multiple failed intermittent urinary catheterizations incurs increased urethral trauma and pain for the patient, increased risk of procedural complications, and increased risk of CAUTI due to repeated urethral instrumentation.

On the basis of and in response to a clear need to develop novel strategies to eliminate CAUTIs in those patients for whom early catheter removal is not deemed clinically appropriate, we collected 8 months of pilot data at our level I trauma center ICU in which we prophylactically instilled an antibiotic containing irrigation solution into the indwelling foley catheters in patients who required catheterization for greater than 3 days. Over the observed pilot period zero CAUTI events were recorded as compared to a comparison control group of trauma patients with identical inclusion criteria for whom 9 "never event" CAUTIs were incurred. These differences were statistically significant.

The current proposal aims to expand this pilot data and conduct a full randomized trial to validate the efficacy of gentamicin antibiotic irrigation in critically ill patients with an indwelling foley catheter of greater than 3 days duration. We plan to expand our patient population to include critically ill patients admitted to the trauma, neuro-critical care and medical ICU units.

The current proposal aims to expand this pilot data and conduct a randomized trial to validate the efficacy of gentamicin antibiotic irrigation in critically ill patients with an indwelling foley catheter of greater than 3 days duration. We plan to expand our patient population to include critically ill patients admitted to the trauma, neuro-critical care and medical ICU units. Our primary research question is: Is prophylactic gentamicin bladder irrigation associated with decreased CAUTI in a cohort of catheterized trauma and neuro critical care patients.

Being tested
Gentamicin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GentamicinDrug

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

Study groups in NCT06332040
Study groupRoleWhat they receive
GentamicinExperimental14.4 mg gentamicin dissolved in 30 mL 0f 0.9% saline administered BID
Receives: Drug: Gentamicin
PlaceboPlacebo comparator30 mL of 0.9% saline administered BID
Receives: Drug: Gentamicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CAUTI as primary outcome

    positive urine culture

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2024
  2. Study start9 Oct 2023
  3. Primary completion8 Oct 2026 (estimated)
  4. Study completion8 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06332040
Sponsor's protocol ID
22-500-243-50-35
Status last verified
Jun 2025
First submitted
19 Mar 2024
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gentamicin in people with Catheter Infection, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kristina M Kupanoff, PhD (602-406-5192, Kristina.Kupanoff@commonspirit.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CAUTI as primary outcome (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.

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