BIP Foley in Prevention of CAUTI at Rehab Station

Phase 4

Completed

• Conditions: Complications; Catheter, Urinary Infection or Inflammation
• Interventions: Device: BIP Foley (latex) or BIP Foley -silicone; Device: Standard catheter

• Registration Number: NCT02808000
• Lead Sponsor: Bactiguard AB

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-21
• Study First Submitted: 2016-06-17
• Study First Submitted QC: 2016-06-17
• Study First Posted: 2016-06-21
• Primary Completion: 2020-03-09
• Study Completion: 2020-03-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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))

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2 (also called Group B)	BIP Foley (latex) or BIP Foley -silicone	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 1 (also called Group A )	BIP Foley (latex) or BIP Foley -silicone	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 2 (also called Group B)	Standard catheter	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 1 (also called Group A )	Standard catheter	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).

Primary Outcome Measures

Name	Time	Method
Incidence of CAUTI	~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)

Secondary Outcome Measures

Name	Time	Method
Antibiotics, number of treatment days	~4 year observational time, the study has an open end and may be prolonged	To assess and compare any differences of number of treatment days of antibiotics used for CAUTI in the two arms.
Incidence of spontaneous urinary and blood cultures and CRP blood	~4 year observational time, the study has an open end and may be prolonged	To asess and compare the spontaneous urinary and blood cultures and CRP blood in the two arms
Antibiotics type	~4 year observational time, the study has an open end and may be prolonged	To assess and compare any differences of type of antibiotics used for CAUTI in the two arms.
Incidence of bacteruria, bacteremia, urosepsis and asymptomatic bacteremia	~4 year observational time, the study has an open end and may be prolonged	To asess and compare the incidence of bacteruria, bacteremia, urosepsis and asymptomatic bacteremiain the two arms
Incidence and typ of advese events	~4 year observational time, the study has an open end and may be prolonged	To assess and compare the frequency and type of adverse events and catheter related adverse events in the two arms
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	The coated and uncoated catheters will be compared with regards to number of easy catheterization.
Antibiotics dose	~4 year observational time, the study has an open end and may be prolonged	To assess and compare any differences of antibiotic dose used for CAUTI in the two arms.

Trial Locations

Locations (1)

Rehab Station Stockholm; 🇸🇪 Stockholm, Solna, Sweden