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

Urinary Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02658903
• Other study ID #: Oxys-01
• Status: Recruiting
• Phase: Phase 1
• First received: November 20, 2015
• Last updated: January 19, 2016
• Start date: January 2016
• Est. completion date: January 2017

Study information

• Verified date: January 2016
• Source: Oxys Medical AG
• Contact: Christoph Scharf, MD
• Phone: ++41763322969
• Email: christoph.scharf[@]gmail.com
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Infections
• Urinary Tract Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital Balgrist	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Oxys Medical AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study.		4 weeks	No
Secondary	Significant bacteriuria assessed by weekly bacterial cultures.		every week during 4 weeks	No
Secondary	Clinically symptomatic catheter associated lower urinary infections.		4 weeks	No
Secondary	occurence of adverse events	safety endpoint	within 4 weeks	Yes