Critical IllnessCABNCT03816384
Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria
A study testing DLC Group and DLCS Group in people with Critical Illness and Burns, run by Potrero Medical.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Burns, Surgery
- What is being tested?
- DLC Group and DLCS Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2020to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness, Burns, Surgery, Urinary Tract Infections, Bacteriuria
- Being tested
- Standard of Care, DLC Group, DLCS Group
- Keywords
- urinary catheter
- Medical subject headings
- Critical Illness, Burns, Urinary Tract Infections, Bacteriuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareDevice
Standard of care urinary drainage system.
DLC GroupDevice
Urinary drainage system with active drain line clearance and plain silicone catheter.
DLCS GroupDevice
Urinary drainage system with active drain line clearance and silver-doped silicone catheter.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Patients will receive Standard of Care, commercially available catheter utilized by hospital system. Receives: Device: Standard of Care |
| Drain Line Clearance (DLC) Group | Experimental | Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and plain silicone catheter. Receives: Device: DLC Group |
| Drain Line Clearance and Silver (DLCS) Group | Experimental | Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and silver-doped silicone catheter. Receives: Device: DLCS Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start31 Jan 2020 (estimated)
- Primary completion31 Jan 2020 (estimated)
- Study completion31 Jan 2020 (estimated)
Why it stopped: Declined to pursue Study due to anticipated low enrollment numbers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, Randomized-Controlled-Trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Potrero Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Foster, MD, Principal investigator, Maricopa Integrated Health System (MIHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816384
- Sponsor's protocol ID
- CRD-06-100548
- Acronym
- CAB
- Status last verified
- Jan 2020
- First submitted
- 22 Jan 2019
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Active Drain Line Clearance With or Without Silver on Catheter-Associated Bacteriuria (The CAB Study)
- ClinicalTrials.gov ID
- NCT03816384
- Acronym / sponsor ID
- CAB / CRD-06-100548
- Conditions
- Critical Illness, Burns, Surgery, Urinary Tract Infections, Bacteriuria
- Keywords
- urinary catheter
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Declined to pursue Study due to anticipated low enrollment numbers
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Potrero MedicalIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2020 (estimated)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Multi-center, Randomized-Controlled-Trial
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Device: Standard of CarePatients will receive Standard of Care, commercially available catheter utilized by hospital system. |
| Drain Line Clearance (DLC) Group | Experimental | Device: DLC GroupPatients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and plain silicone catheter. |
| Drain Line Clearance and Silver (DLCS) Group | Experimental | Device: DLCS GroupPatients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and silver-doped silicone catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareStandard of care urinary drainage system. | Device | Standard of Care |
| DLC GroupUrinary drainage system with active drain line clearance and plain silicone catheter. | Device | Drain Line Clearance (DLC) Group |
| DLCS GroupUrinary drainage system with active drain line clearance and silver-doped silicone catheter. | Device | Drain Line Clearance and Silver (DLCS) Group |
Primary outcome
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.
3 secondary outcomes
Percentage of asymptomatic (ASB) and symptomatic (CAUTI) bacteriuria
Time frame: 30 days
Time to Bacteriuria (ASB and CAUTI)
Time frame: 30 days
Urine Culture Comparisons
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Foster, MD principal investigator
Maricopa Integrated Health System (MIHS)
Questions about this trial
What is this clinical trial studying?
A study testing DLC Group and DLCS Group in people with Critical Illness and Burns, run by Potrero Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in percentage of catheter-associated bacteriuria (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.