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

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ClinicalTrials.gov Identifier: NCT02808000
Recruitment Status : Unknown
Verified June 2016 by Bactiguard AB.
Recruitment status was:  Recruiting
First Posted : June 21, 2016
Last Update Posted : June 21, 2016
Sponsor:
Collaborator:
Rehab Station Stockholm
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Complications; Catheter, Urinary Infection or Inflammation Device: BIP Foley (latex) or BIP Foley -silicone Device: Standard catheter Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : April 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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).
Device: BIP Foley (latex) or BIP Foley -silicone
Other Name: Noble metal coated urinary catheters

Device: Standard catheter
Other Name: Standard urinary catheter

Experimental: 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).
Device: BIP Foley (latex) or BIP Foley -silicone
Other Name: Noble metal coated urinary catheters

Device: Standard catheter
Other Name: Standard urinary catheter




Primary Outcome Measures :
  1. Determine efficacy of BIP Foleys in reduction of symptomatic catheter associated urinary tract infections (CAUTI) [ Time Frame: ~2 year observational time, the study has an open end and may be prolonged ]
    frequency of CAUTI will be recorded and compared between standard and BIP Foley use


Secondary Outcome Measures :
  1. Adverse events and catheter related adverse events [ Time Frame: ~2 year observational time, the study has an open end and may be prolonged ]
  2. Catheter performance and ease of use [ Time Frame: ~2 year observational time, the study has an open end and may be prolonged ]
  3. Antibiotics used for CAUTI [ Time Frame: ~2 year observational time, the study has an open end and may be prolonged ]
  4. Spontaneous urinary and blood cultures and CRP bloo [ Time Frame: ~2 year observational time, the study has an open end and may be prolonged ]
  5. Bacteriuria, bacteremia, urosepsis and asymptomatic bacteremia [ Time Frame: ~2 year observational time, the study has an open end and may be prolonged ]

Other Outcome Measures:
  1. Stability of the coating during use, possible metal release in urine and blood [ Time Frame: ~2 year observational time, the study has an open end and may be prolonged ]
  2. Comfort of BIP Foley catheters compared to standard catheters [ Time Frame: ~2 year observational time, the study has an open end and may be prolonged ]
  3. Inflammatory markers [ Time Frame: ~2 year observational time, the study has an open end and may be prolonged ]
  4. Bacterial type and resistance pattern [ Time Frame: ~2 year observational time, the study has an open end and may be prolonged ]
  5. Bacterial biofilm on the catheter surface [ Time Frame: ~2 year observational time, the study has an open end and may be prolonged ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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))

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808000


Contacts
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Contact: Åke Seiger, MD, Prof +46-8-585 801 36 ake.seiger@ki.se
Contact: Dorota Johansson, PhD +46-8-706543171 dorota.johansson@bactiguard.se

Locations
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Sweden
Rehab Station Stockholm Recruiting
Stockholm, Solna, Sweden, 169 89
Contact: Åke Seiger, MD Prof    +46739177407    ake.seiger@ki.se   
Contact: Lena Lindbo, Nurse    +46855544250    lena.lindbo@rehabstation.se   
Sponsors and Collaborators
Bactiguard AB
Rehab Station Stockholm
Investigators
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Principal Investigator: Åke Seiger, MD, Prof Rehab Station Stockholm and Karolinska Institutet, Stockholm Sweden

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Responsible Party: Bactiguard AB
ClinicalTrials.gov Identifier: NCT02808000     History of Changes
Other Study ID Numbers: 3686-2031-CDOC
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infection
Urinary Tract Infections
Inflammation
Pathologic Processes
Urologic Diseases