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.
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
- Recruiting
St. Jpseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Kristina Kupanoff, PhD, 602-406-5192, Kristina.Kupanoff@Commonspirit.org
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.
- Conditions
- Catheter Infection
- 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 group | Role | What they receive |
|---|---|---|
| Gentamicin | Experimental | 14.4 mg gentamicin dissolved in 30 mL 0f 0.9% saline administered BID Receives: Drug: Gentamicin |
| Placebo | Placebo comparator | 30 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.
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.
- First posted26 Mar 2024
- Study start9 Oct 2023
- Primary completion8 Oct 2026 (estimated)
- Study completion8 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hahn Soe-Lin, MD, Principal investigator, St. Joseph's Hospital and Medical Center, Phoenix
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Effectiveness of Gentamicin Bladder Instillation on CAUTI
- ClinicalTrials.gov ID
- NCT06332040
- Acronym / sponsor ID
- 22-500-243-50-35
- Conditions
- Catheter Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 8 Oct 2026 (estimated)
- Study completion
- 8 Oct 2026 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gentamicin | Experimental | Drug: Gentamicin14.4 mg gentamicin dissolved in 30 mL 0f 0.9% saline administered BID |
| Placebo | Placebo comparator | Drug: Gentamicin30 mL of 0.9% saline administered BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age greater than 18
- admitted with a trauma, surgical, or neuro-critical care diagnosis
- indwelling foley catheter in place
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gentamicinrandom assignment to gentamicin or placebo bladder instillation to prevent CAUTI (catheterized urinary track infection) | Drug | Gentamicin, Placebo |
Primary outcome
CAUTI as primary outcome
Time frame: 30 days
positive urine culture
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hahn Soe-Lin, MD principal investigator
St. Joseph's Hospital and Medical Center, Phoenix
1 site in 1 country: see every site and its status.
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.