Complications; Catheter, Urinary Infection or InflammationPhase 4CDOCNCT02808000
BIP Foley in Prevention of CAUTI at Rehab Station
A Phase 4 study testing BIP Foley (latex) or BIP Foley -silicone and Standard catheter in people with Complications; Catheter, Urinary Infection or Inflammation, run by Bactiguard AB at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complications; Catheter, Urinary Infection or Inflammation
- What is being tested?
- BIP Foley (latex) or BIP Foley -silicone and Standard catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSweden
- Study dates
- 21 Apr 2016to 9 Mar 2020
- Phase
- Phase 4
- 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 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)
Who cannot join
- 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))
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
- Being tested
- BIP Foley (latex) or BIP Foley -silicone, Standard catheter
- Medical subject headings
- Urinary Tract Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIP Foley (latex) or BIP Foley -siliconeDevice
Also called Noble metal coated urinary catheters
Standard catheterDevice
Also called Standard urinary catheter
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (also called Group A ) | Active comparator | 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). Receives: Device: BIP Foley (latex) or BIP Foley -silicone; Device: Standard catheter |
| Group 2 (also called Group B) | Experimental | 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). Receives: Device: BIP Foley (latex) or BIP Foley -silicone; Device: Standard catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CAUTI
The frequency of CAUTI will be recorded and compared between the use of standard urinary catheter and BIP Foley (with noble metal coating)
Measured: ~4 year observational time, the study has an open end and may be prolonged
Secondary outcomes (7)
Incidence and typ of advese events
To assess and compare the frequency and type of adverse events and catheter related adverse events in the two arms
Measured: ~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.
The coated and uncoated catheters will be compared with regards to number of easy catheterization.
Measured: ~4 year observational time, the study has an open end and may be prolonged
Antibiotics type
To assess and compare any differences of type of antibiotics used for CAUTI in the two arms.
Measured: ~4 year observational time, the study has an open end and may be prolonged
Antibiotics dose
To assess and compare any differences of antibiotic dose used for CAUTI in the two arms.
Measured: ~4 year observational time, the study has an open end and may be prolonged
Antibiotics, number of treatment days
To assess and compare any differences of number of treatment days of antibiotics used for CAUTI in the two arms.
Measured: ~4 year observational time, the study has an open end and may be prolonged
Incidence of spontaneous urinary and blood cultures and CRP blood
To asess and compare the spontaneous urinary and blood cultures and CRP blood in the two arms
Measured: ~4 year observational time, the study has an open end and may be prolonged
Incidence of bacteruria, bacteremia, urosepsis and asymptomatic bacteremia
To asess and compare the incidence of bacteruria, bacteremia, urosepsis and asymptomatic bacteremiain the two arms
Measured: ~4 year observational time, the study has an open end and may be prolonged
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study start21 Apr 2016
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; Catheter, Urinary Infection or InflammationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bactiguard AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rehab Station Stockholm
- Responsible party
- Sponsor
- Investigators
- Åke Seiger, MD, Prof, Principal investigator, Rehab Station Stockholm and Karolinska Institutet, Stockholm Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808000
- Sponsor's protocol ID
- 3686-2031-CDOC
- Acronym
- CDOC
- Status last verified
- Jan 2021
- First submitted
- 17 Jun 2016
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Suprapubic Noble Metal Alloy BIP Foley Catheter in the Prevention of Catheter-associated Urinary Tract Infections in Spinal Cord Injured Patients
- ClinicalTrials.gov ID
- NCT02808000
- Acronym / sponsor ID
- CDOC / 3686-2031-CDOC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Bactiguard ABIndustry (pharma, biotech, devices)
- Collaborators
- Rehab Station Stockholm
- Study start
- 21 Apr 2016 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 21 Jun 2016 (estimated)
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (also called Group A ) | Active comparator | Device: BIP Foley (latex) or BIP Foley -silicone, Device: Standard catheterGroup 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). |
| Group 2 (also called Group B) | Experimental | Device: BIP Foley (latex) or BIP Foley -silicone, Device: Standard catheterGroup 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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))
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 |
|---|---|---|
| BIP Foley (latex) or BIP Foley -siliconeAlso: Noble metal coated urinary catheters | Device | Group 1 (also called Group A ), Group 2 (also called Group B) |
| Standard catheterAlso: Standard urinary catheter | Device | Group 1 (also called Group A ), Group 2 (also called Group B) |
Primary outcome
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)
7 secondary outcomes
Incidence and typ of advese events
Time frame: ~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
Antibiotics type
Time frame: ~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
Antibiotics, number of treatment days
Time frame: ~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
Incidence of bacteruria, bacteremia, urosepsis and asymptomatic bacteremia
Time frame: ~4 year observational time, the study has an open end and may be prolonged
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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.
Åke Seiger, MD, Prof principal investigator
Rehab Station Stockholm and Karolinska Institutet, Stockholm Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BIP Foley (latex) or BIP Foley -silicone and Standard catheter in people with Complications; Catheter, Urinary Infection or Inflammation, run by Bactiguard AB at 1 site in Sweden.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of CAUTI (time frame: ~4 year observational time, the study has an open end and may be prolonged). 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 22 Jan 2021.