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

• ClinicalTrials.gov Identifier: NCT03816384
• Recruitment Status: Withdrawn
• First Posted: January 25, 2019
• Last Update Posted: January 29, 2020
• Sponsor: Potrero Medical
• Information provided by (Responsible Party): Potrero Medical

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Critical Illness; Burns; Surgery; Urinary Tract Infections; Bacteriuria	Device: Standard of Care; Device: DLC Group; Device: DLCS Group	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Multi-center, Randomized-Controlled-Trial
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of Active Drain Line Clearance With or Without Silver on Catheter-Associated Bacteriuria (The CAB Study)
• Estimated Study Start Date: January 31, 2020
• Estimated Primary Completion Date: January 31, 2020
• Estimated Study Completion Date: January 31, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Difference in percentage of catheter-associated bacteriuria [ Time Frame: 30 days ]
   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.

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Potrero Medical

Investigators

• Principal Investigator: Kevin Foster, MD; Maricopa Integrated Health System (MIHS)

More Information

• Responsible Party: Potrero Medical
• ClinicalTrials.gov Identifier: NCT03816384
• Other Study ID Numbers: CRD-06-100548
• First Posted: January 25, 2019
• Last Update Posted: January 29, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Potrero Medical:

urinary catheter

Additional relevant MeSH terms:

Urinary Tract Infections; Bacteriuria; Critical Illness; Infections; Urologic Diseases; Disease Attributes; Pathologic Processes