Back to resultsPrevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter
Primary Purpose
Urinary Infections
Status
Unknown status
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Oxys Catheter
Covidien Mona-Therm Foley catheter
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Infections focused on measuring Foley, Infection, Hospital acquired, catheter associated, urinary
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
Sites / Locations
- University Hospital BalgristRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Study arm with Oxys-Cathter
Control-arm with commercial catheter
Arm Description
The study group is treated with a modified urinary catheter, which delivers electromagnetic therapy to prevent and treat bacterial colonization during the study period. The intervention is the insertion of the study urinary catheter (foley) into the bladder.
The control group is treated with a commercial urinary catheter. The intervention is the insertion of the control urinary catheter (foley) into the bladder,
Outcomes
Primary Outcome Measures
Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study.
Secondary Outcome Measures
Significant bacteriuria assessed by weekly bacterial cultures.
Clinically symptomatic catheter associated lower urinary infections.
occurence of adverse events
safety endpoint
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02658903
Brief Title
Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter
Official Title
Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oxys Medical AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Infections
Keywords
Foley, Infection, Hospital acquired, catheter associated, urinary
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study arm with Oxys-Cathter
Arm Type
Experimental
Arm Description
The study group is treated with a modified urinary catheter, which delivers electromagnetic therapy to prevent and treat bacterial colonization during the study period. The intervention is the insertion of the study urinary catheter (foley) into the bladder.
Arm Title
Control-arm with commercial catheter
Arm Type
Other
Arm Description
The control group is treated with a commercial urinary catheter. The intervention is the insertion of the control urinary catheter (foley) into the bladder,
Intervention Type
Device
Intervention Name(s)
Oxys Catheter
Intervention Description
The study catheter is inserted over the urethra in the bladder as a foley catheter. The study foley catheter delivers electromagnetic therapy.
Intervention Type
Device
Intervention Name(s)
Covidien Mona-Therm Foley catheter
Intervention Description
The control arm catheter is inserted over the urethra in the bladder. The control catheter is a Mona-Therm catheter from Covidien.
Primary Outcome Measure Information:
Title
Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Significant bacteriuria assessed by weekly bacterial cultures.
Time Frame
every week during 4 weeks
Title
Clinically symptomatic catheter associated lower urinary infections.
Time Frame
4 weeks
Title
occurence of adverse events
Description
safety endpoint
Time Frame
within 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph Scharf, MD
Phone
++41763322969
Email
christoph.scharf@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Tivig, MD
Phone
+41 787358855
Email
ki.tivig@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kessler, MD
Organizational Affiliation
Universitätsklinik Balgrist Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Balgrist
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Kessler, Prof., MD
Phone
0041 44 386 11 11
Email
Thomas.Kessler@balgrist.ch
First Name & Middle Initial & Last Name & Degree
Ulrich Menert, MD
Phone
0041 44 386 56 68
Email
Ulrich.Mehnert@balgrist.ch
12. IPD Sharing Statement
Learn more about this trial
Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter
We'll reach out to this number within 24 hrs