BIP Foley in Prevention of CAUTI at Rehab Station

NCT02808000 | Completed Phase 4

• 1 other identifier: 3686-2031-CDOC
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

  ~4 year observational time, the study has an open end and may be prolonged

Secondary Outcomes (7)

• Incidence and typ of advese events

  ~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.

  ~4 year observational time, the study has an open end and may be prolonged

• Antibiotics type

  ~4 year observational time, the study has an open end and may be prolonged

• Antibiotics dose

  ~4 year observational time, the study has an open end and may be prolonged

• Antibiotics, number of treatment days

  ~4 year observational time, the study has an open end and may be prolonged

Other Outcomes (6)

• 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,

  ~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.

  ~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.

  ~4 year observational time, the study has an open end and may be prolonged

Study Arms (2)

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).

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).

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

Interventions

BIP Foley (latex) or BIP Foley -silicone DEVICE

Also known as: Noble metal coated urinary catheters

Group 1 (also called Group A ); Group 2 (also called Group B)

Standard catheter DEVICE

Also known as: Standard urinary catheter

Group 1 (also called Group A ); Group 2 (also called Group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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))

Sponsors & Collaborators

• Bactiguard AB: lead
• Rehab Station Stockholm: collaborator

Study Sites (1)

Rehab Station Stockholm

Stockholm, Solna, 169 89, Sweden

Location

MeSH Terms

Conditions

Urinary Tract Infections; Inflammation

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Åke Seiger, MD, Prof

  Rehab Station Stockholm and Karolinska Institutet, Stockholm Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: June 21, 2016
• Study Start: April 21, 2016
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)