Clinical trial
A Randomized Controlled Trial to Evaluate the Effectiveness of Gentamicin Bladder Instillation on CAUTI
Name
22-500-243-50-35
Description
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 arms
Trial start
2023-10-09
Estimated PCD
2026-10-08
Trial end
2026-10-08
Status
Recruiting
Phase
Early phase I
Treatment
Gentamicin
random assignment to gentamicin or placebo bladder instillation to prevent CAUTI (catheterized urinary track infection)
Arms:
Gentamicin, Placebo
Size
400
Primary endpoint
CAUTI as primary outcome
30 days
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}
Updated at
2024-03-26
1 organization
1 product
1 indication
Organization
St. Joseph's Hospital and Medical CenterProduct
GentamicinIndication
Catheter-related bloodstream infection