Clinical trial NCT02808000: BIP Foley in Prevention of CAUTI at Rehab Station
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Complications; Catheter, Urinary Infection or Inflammation
Lead sponsor: Bactiguard AB
Sponsor class: INDUSTRY
Collaborators: name: Rehab Station Stockholm
First posted: 2016-06-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: 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))

Primary outcomes:
measure: Incidence of CAUTI
timeFrame: ~4 year observational time, the study has an open end and may be prolonged
Secondary outcomes:
measure: Incidence and typ of advese events
timeFrame: ~4 year observational time, the study has an open end and may be prolonged
measure: To compare ease of use of catheter by the nurse. Satisfaction assessed by ticking "easy" or "not easy" after each catheter exchange.
timeFrame: ~4 year observational time, the study has an open end and may be prolonged
measure: Antibiotics type
timeFrame: ~4 year observational time, the study has an open end and may be prolonged
measure: Antibiotics dose
timeFrame: ~4 year observational time, the study has an open end and may be prolonged
measure: Antibiotics, number of treatment days
timeFrame: ~4 year observational time, the study has an open end and may be prolonged
measure: Incidence of spontaneous urinary and blood cultures and CRP blood
timeFrame: ~4 year observational time, the study has an open end and may be prolonged
measure: Incidence of bacteruria, bacteremia, urosepsis and asymptomatic bacteremia
timeFrame: ~4 year observational time, the study has an open end and may be prolonged
Other outcomes:
measure: 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,
timeFrame: ~4 year observational time, the study has an open end and may be prolonged
measure: To assess the comfort of BIP Foley Catheters. Comfort is measured by a questionnaire filled in by the patients.
timeFrame: ~4 year observational time, the study has an open end and may be prolonged
measure: To asess inflammatory markers in urine of the patients and compare their levels between the groups.
timeFrame: ~4 year observational time, the study has an open end and may be prolonged
measure: To assess bacterial type
timeFrame: ~4 year observational time, the study has an open end and may be prolonged
measure: To assess bacterial resistance pattern.
timeFrame: ~4 year observational time, the study has an open end and may be prolonged
measure: To assess and compare biofilm amount on the catheter surface.
timeFrame: ~4 year observational time, the study has an open end and may be prolonged
Locations:
city: Stockholm
country: Sweden
facility: Rehab Station Stockholm
state: Solna
Study officials:
affiliation: Rehab Station Stockholm and Karolinska Institutet, Stockholm Sweden
name: Åke Seiger, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: