BIP Foley in Prevention of CAUTI at Rehab Station

NCT ID: NCT02808000

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-21
• Study Completion Date: 2020-03-09

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.

Conditions

Complications; Catheter, Urinary Infection or Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

BIP Foley (latex) or BIP Foley -silicone

Intervention Type: DEVICE

Standard catheter

Intervention Type: DEVICE

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).

Group Type: EXPERIMENTAL

BIP Foley (latex) or BIP Foley -silicone

Intervention Type: DEVICE

Standard catheter

Intervention Type: DEVICE

Interventions

BIP Foley (latex) or BIP Foley -silicone

Intervention Type: DEVICE

Standard catheter

Intervention Type: DEVICE

Other Intervention Names

Noble metal coated urinary catheters; Standard urinary catheter

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))

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rehab Station Stockholm

UNKNOWN

Sponsor Role: collaborator

Bactiguard AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Åke Seiger, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Rehab Station Stockholm and Karolinska Institutet, Stockholm Sweden

Locations

Rehab Station Stockholm

Stockholm, Solna, Sweden

Countries

Sweden

Other Identifiers

3686-2031-CDOC

Identifier Type: -

Identifier Source: org_study_id