Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria

Study Overview
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Brief Summary
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Catheter-associated urinary tract infections (CAUTI) are the most common nosocomial infections in critically ill patients and are responsible for high morbidity rates, increased hospital stays and associated costs. The purpose of this study is to evaluate whether active drain line clearance by the Accuryn Monitoring System reduces the incidence of CAUTI in hospitalized patients requiring catheters.

Detailed Description
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Urinary tract infection (UTI) is the most common healthcare associated infection (HAI) acquired in hospitals and is estimated to account for approximately 13% of hospital infections in the United States, of which 75% are associated with indwelling urinary catheters. It is estimated that between 12-16% adult inpatients will receive an indwelling urinary catheter during their hospital stay. The rate of catheter-associated UTI (CAUTI) are highest in burn ICUs, followed by inpatient medical wards and neurosurgical ICUs. The purpose of this study is to evaluate whether active drain line clearance by the Accuryn Monitoring System reduces the incidence of bacteriuria and/or CAUTI in patients requiring catheters for more than 72 hours. This study will also evaluate the efficacy in reducing bacteriuria of the Accuryn silver fabricated silicone catheters.

Official Title
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Effect of Active Drain Line Clearance With or Without Silver on Catheter-Associated Bacteriuria (The CAB Study)

Conditions
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Critical Illness, Burns, Surgery, Urinary Tract Infections, Bacteriuria

Intervention / Treatment
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* Device: Standard of Care
* Device: DLC Group
* Device: DLCS Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (age ≥ 18) Patient or Legally Authorized Representative (LAR) possess the capacity to provide informed consent Indication for a urinary bladder catheter (or one currently in place) Expected urinary catheter requirement ≥ 72 hours No current urinary tract infection No current indication for prophylactic antibiotics. If a surgical patient, receive perioperative antibiotics for no greater than 24 hours Exclusion Criteria: Inability to receive a urinary bladder catheter Chronic suprapubic catheter in place Expected survival < 72 hours Receipt of systemic antibiotics within 48 hours of enrollment, other than prophylactic antibiotics given at the time of surgery Surgery of the genitourinary tract in the past 6 months prior to admission Deemed unfit for the protocol by the investigator for any reason

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multi-center, Randomized-Controlled-Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Patients will receive Standard of Care, commercially available catheter utilized by hospital system. | Device: Standard of Care<br>* Standard of care urinary drainage system.<br>|
| Experimental: Drain Line Clearance (DLC) Group<br>Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and plain silicone catheter. | Device: DLC Group<br>* Urinary drainage system with active drain line clearance and plain silicone catheter.<br>|
| Experimental: Drain Line Clearance and Silver (DLCS) Group<br>Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and silver-doped silicone catheter. | Device: DLCS Group<br>* Urinary drainage system with active drain line clearance and silver-doped silicone catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in percentage of catheter-associated bacteriuria | To study the difference in rate of catheter-associated bacteriuria between SOC catheters and Accuryn silicone or Accuryn silver-doped catheters with active drain line clearance. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of asymptomatic (ASB) and symptomatic (CAUTI) bacteriuria | To study the incidence and progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours. | 30 days | 
| Time to Bacteriuria (ASB and CAUTI) | To study the progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours. | 30 days | 
| Urine Culture Comparisons | To study the correlation between patient urine cultures and cultures taken from the Foley (Foley tip, urine sampled from collection bag). | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary catheter