BIP Foley in Prevention of CAUTI at Rehab Station (CDOC)

January 20, 2021 updated by: Bactiguard AB

Evaluation of Suprapubic Noble Metal Alloy BIP Foley Catheter in the Prevention of Catheter-associated Urinary Tract Infections in Spinal Cord Injured Patients

This is a prospective, cross-over, randomized, controlled, partly blinded study evaluating safety and performance of noble metal alloy urinary Catheters (BIP Foley, Bactiguard AB) of both latex and silicone. The included patients are permanently catheterized spinal cord injured patients at the Spinalis clinic at Rehab station in Stockholm, Sweden.

Primary Outcome Measures:

• The primary objective is to evaluate the efficacy of long term suprapubic use of BIP Foley catheters, compared to the use of standard catheters for the same time period, on re-current symptomatic catheter associated urinary tract infection (CAUTIs).

Secondary Outcome Measures:

• to evaluate safety/performance of the catheter, i.e. antibiotic use, bacteriuria, bacteremia, urosepsis and ICU stay.

Exploratory Outcome Measures:

• assessment of levels of immunological markers in urine, urinary bacterial type and resistance pattern, catheter comfort, stability of the coating, and bacterial biofilm on the catheter surface after use.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Solna
      • Stockholm, Solna, Sweden, 169 89
        • Rehab Station Stockholm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients (≥18 years)
  • Patients with permanent suprapubic urethral catheter (Foley catheter) of latex or silicone
  • At least 3 documented CAUTI infections during last year
  • Spinal Cord Injured, changing catheters at Rehab Station every 10 weeks (+/- 2 weeks)

Exclusion Criteria:

  • Children (˂18 years)
  • Participating in other clinical trial(s) with exposure/treatment that could affect the outcome of the present study
  • Stones (calculi) in the urinary tract (these patients can be included after the stones have been removed)
  • Patients on antibiotic treatment (these patients can be included after the treatment is completed (+10 days of expectance))

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1 (also called Group A )
Group 1/A will use standard catheter during the first ~6 months (observational period 1). Then the patients in this group will switch to the noble metal alloy urinary catheter (BIP Foley catheter of latex or silicone produced by Bactiguard AB) and be observed for another ~6 months (the second observational period).
Device: BIP Foley (latex) or BIP Foley -silicone
Other Names:
  • Noble metal coated urinary catheters
Device: Standard catheter
Other Names:
  • Standard urinary catheter
Experimental: Group 2 (also called Group B)
Group 2/B will use the BIP Foley (latex or silicone) during the first ~6 months (observational period 1). Then the patients in this group will switch to the standard catheter and be observed for another ~6 months (the second observational period).
Device: BIP Foley (latex) or BIP Foley -silicone
Other Names:
  • Noble metal coated urinary catheters
Device: Standard catheter
Other Names:
  • Standard urinary catheter

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of CAUTI
Time Frame: ~4 year observational time, the study has an open end and may be prolonged
The frequency of CAUTI will be recorded and compared between the use of standard urinary catheter and BIP Foley (with noble metal coating)
~4 year observational time, the study has an open end and may be prolonged

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence and typ of advese events
Time Frame: ~4 year observational time, the study has an open end and may be prolonged
To assess and compare the frequency and type of adverse events and catheter related adverse events in the two arms
~4 year observational time, the study has an open end and may be prolonged
To compare ease of use of catheter by the nurse. Satisfaction assessed by ticking "easy" or "not easy" after each catheter exchange.
Time Frame: ~4 year observational time, the study has an open end and may be prolonged
The coated and uncoated catheters will be compared with regards to number of easy catheterization.
~4 year observational time, the study has an open end and may be prolonged
Antibiotics type
Time Frame: ~4 year observational time, the study has an open end and may be prolonged
To assess and compare any differences of type of antibiotics used for CAUTI in the two arms.
~4 year observational time, the study has an open end and may be prolonged
Antibiotics dose
Time Frame: ~4 year observational time, the study has an open end and may be prolonged
To assess and compare any differences of antibiotic dose used for CAUTI in the two arms.
~4 year observational time, the study has an open end and may be prolonged
Antibiotics, number of treatment days
Time Frame: ~4 year observational time, the study has an open end and may be prolonged
To assess and compare any differences of number of treatment days of antibiotics used for CAUTI in the two arms.
~4 year observational time, the study has an open end and may be prolonged
Incidence of spontaneous urinary and blood cultures and CRP blood
Time Frame: ~4 year observational time, the study has an open end and may be prolonged
To asess and compare the spontaneous urinary and blood cultures and CRP blood in the two arms
~4 year observational time, the study has an open end and may be prolonged
Incidence of bacteruria, bacteremia, urosepsis and asymptomatic bacteremia
Time Frame: ~4 year observational time, the study has an open end and may be prolonged
To asess and compare the incidence of bacteruria, bacteremia, urosepsis and asymptomatic bacteremiain the two arms
~4 year observational time, the study has an open end and may be prolonged

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess the stability of the coating during long term use, by measurement of the (i.e. Ag, Au and Pd) concentration in urine and in blood and on used catheters,
Time Frame: ~4 year observational time, the study has an open end and may be prolonged
Urine and blood samples as well as used BIP Foley catheters, will be collected during the study visit, and the samples will be analysed with regards to metal concentrations (Ag, Au, and Pd).
~4 year observational time, the study has an open end and may be prolonged
To assess the comfort of BIP Foley Catheters. Comfort is measured by a questionnaire filled in by the patients.
Time Frame: ~4 year observational time, the study has an open end and may be prolonged
The outcome of the questionnaire will be compared between the groups (standard versus coated catheter). The questions assess urine smell, appearance of the urine (i.e. colour), discomfort caused by the catheter, catheter blockage, discomfort at insertion/removal, and will be rated in a three-scale (not at all, little, much).
~4 year observational time, the study has an open end and may be prolonged
To asess inflammatory markers in urine of the patients and compare their levels between the groups.
Time Frame: ~4 year observational time, the study has an open end and may be prolonged
Urine samples will be collected during the study visit, and will be analysed with regards to inflammatory markers. Inflammatory levels (e.g. cytokines IL-8 and microparticles) will be determined, and compared between the groups.
~4 year observational time, the study has an open end and may be prolonged
To assess bacterial type
Time Frame: ~4 year observational time, the study has an open end and may be prolonged
The occurancy of bacterial strains in the two groups will be compared in urine samples collected at each study visit.
~4 year observational time, the study has an open end and may be prolonged
To assess bacterial resistance pattern.
Time Frame: ~4 year observational time, the study has an open end and may be prolonged
The resistance pattern of present urinary bacteria in the two groups will be compared in urine samples collected at each study visit.
~4 year observational time, the study has an open end and may be prolonged
To assess and compare biofilm amount on the catheter surface.
Time Frame: ~4 year observational time, the study has an open end and may be prolonged
Biofilm amount on the catheter surface of uncoated and coated catheters will be assessed and compared by using SEM. Amounts will be given as % biofilm covering the surface area.
~4 year observational time, the study has an open end and may be prolonged

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bactiguard AB

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rehab Station Stockholm

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Åke Seiger, MD, Prof, Rehab Station Stockholm and Karolinska Institutet, Stockholm Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 21, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 9, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 9, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3686-2031-CDOC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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