NCT06332040 Gentamicin Bladder Instillation on CAUTI
| NCT ID | NCT06332040 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | St. Joseph's Hospital and Medical Center, Phoenix |
| Condition | Catheter Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-10-09 |
| Primary Completion | 2026-10-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 400 participants in total. It began in 2023-10-09 with a primary completion date of 2026-10-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Hahn Soe-Lin, MD
PRINCIPAL INVESTIGATOR
St. Joseph's Hospital and Medical Center, Phoenix
Frequently Asked Questions
Who can join the NCT06332040 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Catheter Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06332040 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06332040 currently recruiting?
Yes, NCT06332040 is actively recruiting participants. Contact the research team at Kristina.Kupanoff@commonspirit.org for enrollment information.
Where is the NCT06332040 trial being conducted?
This trial is being conducted at Phoenix, United States.
Who is sponsoring the NCT06332040 clinical trial?
NCT06332040 is sponsored by St. Joseph's Hospital and Medical Center, Phoenix. The principal investigator is Hahn Soe-Lin, MD at St. Joseph's Hospital and Medical Center, Phoenix. The trial plans to enroll 400 participants.