Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria (CAB)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Burns; Critical Illness; Bacteriuria; Urinary Tract Infections; Surgery
• Intervention / Treatment: Device: Standard of Care; Device: DLC Group; Device: DLCS Group

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult (age ≥ 18)
2. Patient or Legally Authorized Representative (LAR) possess the capacity to provide informed consent
3. Indication for a urinary bladder catheter (or one currently in place)
4. Expected urinary catheter requirement ≥ 72 hours
5. No current urinary tract infection
6. No current indication for prophylactic antibiotics. If a surgical patient, receive perioperative antibiotics for no greater than 24 hours

Exclusion Criteria:

1. Inability to receive a urinary bladder catheter
2. Chronic suprapubic catheter in place
3. Expected survival < 72 hours
4. Receipt of systemic antibiotics within 48 hours of enrollment, other than prophylactic antibiotics given at the time of surgery
5. Surgery of the genitourinary tract in the past 6 months prior to admission
6. Deemed unfit for the protocol by the investigator for any reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Potrero Medical
• Investigators: Principal Investigator: Kevin Foster, MD, Maricopa Integrated Health System (MIHS)

Study record dates

Study Major Dates

• Study Start (Anticipated): January 31, 2020
• Primary Completion (Anticipated): January 31, 2020
• Study Completion (Anticipated): January 31, 2020

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: urinary catheter
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Urologic Diseases; Disease Attributes; Urinary Tract Infections; Bacteriuria; Critical Illness
• Other Study ID Numbers: CRD-06-100548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No