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

Bactiguard

Status and phase: Completed; Phase 4

Conditions: Complications; Catheter, Urinary Infection or Inflammation

Treatments: Device: BIP Foley (latex) or BIP Foley -silicone; Device: Standard catheter

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02808000

3686-2031-CDOC

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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))

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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14 participants in 2 patient groups

Group 1 (also called Group A )

Active Comparator group

Description:

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).

Treatment:

Device: Standard catheter

Device: BIP Foley (latex) or BIP Foley -silicone

Group 2 (also called Group B)

Experimental group

Description:

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).

Treatment:

Device: Standard catheter

Device: BIP Foley (latex) or BIP Foley -silicone