Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter

January 19, 2016 updated by: Oxys Medical AG
The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study arm with Oxys-Cathter
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.
Device: Oxys Catheter
The study catheter is inserted over the urethra in the bladder as a foley catheter. The study foley catheter delivers electromagnetic therapy.
Other: Control-arm with commercial catheter
The control group is treated with a commercial urinary catheter. The intervention is the insertion of the control urinary catheter (foley) into the bladder,
Device: Covidien Mona-Therm Foley catheter
The control arm catheter is inserted over the urethra in the bladder. The control catheter is a Mona-Therm catheter from Covidien.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study.
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Significant bacteriuria assessed by weekly bacterial cultures.
Time Frame: every week during 4 weeks
every week during 4 weeks
Clinically symptomatic catheter associated lower urinary infections.
Time Frame: 4 weeks
4 weeks
occurence of adverse events
Time Frame: within 4 weeks
safety endpoint
within 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxys Medical AG

Investigators

  • Principal Investigator: Thomas Kessler, MD, Universitätsklinik Balgrist Zürich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

November 20, 2015

First Submitted That Met QC Criteria

January 19, 2016

First Posted (Estimate)

January 20, 2016

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oxys-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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