Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Urinary Infections
- Sponsor
- Oxys Medical AG
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study.
- Last Updated
- 10 years ago
Overview
Brief Summary
The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied.
Detailed Description
This study is an open randomized controlled trial of 4 weeks duration. The intervention is a novel urinary catheter with an electromagnetic therapy to prevent catheter associated infections. The catheter is used in patients which require longterm urinary catheterization over at least 1 month. The endpoint is bacteriological exam and the laboratory is blinded to the therapy status. Weekly urinary cultures are drawn and a sonication culture of the catheter tip is performed to detect and characterize the biofilm. A colonization rate of \>95% is anticipated in the control arm. Therefore a 50% reduction in colonization can be detected with 54 patients, a 90% reduction in colonization can be detected with 20 patients with a power of 0.9.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient with need for an indwelling urinary catheter to be placed at least for 4 weeks, which are willing and capable to provide informed consent. Most patients have spinal cord injury and are treated by the prinicpal investigator.
Exclusion Criteria
- •Need for antibiotic treatment for any infections
- •Urological intervention or need for catheter change within study duration of 4 weeks
Outcomes
Primary Outcomes
Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study.
Time Frame: 4 weeks
Secondary Outcomes
- Significant bacteriuria assessed by weekly bacterial cultures.(every week during 4 weeks)
- occurence of adverse events(within 4 weeks)
- Clinically symptomatic catheter associated lower urinary infections.(4 weeks)