Status:
UNKNOWN
The Impact Of A Catheter Coating On Clinical Bacteriuria
Lead Sponsor:
Camstent Ltd.
Conditions:
Bacteriuria
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A prospective multicentre randomized study to assess the impact of a catheter coating on clinical bacteriuria when compared to an uncoated foley catheter. Each participant will take part in the trial...
Eligibility Criteria
Inclusion
- Require insertion or exchange of a catheter as a component of their routine clinical care as per hospital guidelines
- Patients aged 18+ years will be eligible for the study.
- Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.
Exclusion
- Patients that have or recently (within 3 weeks) had a urinary catheter and displays symptoms of current urinary tract infection.
- Pregnant or Breastfeeding.
- Patients with a potentially immunocompromised conditions (HIV)
- Has a known silicone allergy or sensitivity
- Use of investigational drug or device within four weeks prior to study entry that may interfere with this study.
- Any medication deemed by the Investigator to potentially interfere with the study treatment
- Participation in any other clinical study.
- Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT04461262
Start Date
April 27 2021
End Date
October 1 2024
Last Update
December 28 2022
Active Locations (4)
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1
Stoke Mandeville Hospital
Buckingham, United Kingdom
2
Addenbrookes Hospital
Cambridge, United Kingdom
3
Royal National Orthopaedic Hospital
London, United Kingdom
4
Norfolk & Norwich University Hospital
Norwich, United Kingdom