The Impact Of A Catheter Coating On Clinical Bacteriuria (NCT04461262) | Clinical Trial Compass
UnknownNot Applicable
The Impact Of A Catheter Coating On Clinical Bacteriuria
United Kingdom272 participantsStarted 2021-04-27
Plain-language 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 from the time the participant signs the informed consent form (ICF).
After the screening visit, the participants will be randomized to either a coated catheter or an uncoated catheter. Participants will be assigned to receive trial treatment until the catheter has been removed as per standard hospital guidelines, investigator's decision to withdraw the subject, noncompliance with trial treatment or procedures, unacceptable adverse event, or participant withdraws consent.
During the trial urine samples will be taken form the catheter port, temperature will be taken, and participants and healthcare providers will be asked to complete questionnaires.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Require insertion or exchange of a catheter as a component of their routine clinical care as per hospital guidelines
ā. Patients aged 18+ years will be eligible for the study.
ā. Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.
Exclusion criteria
ā. Patients that have or recently (within 3 weeks) had a urinary catheter and displays symptoms of current urinary tract infection.
ā. Pregnant or Breastfeeding.
ā. Patients with a potentially immunocompromised conditions (HIV)
ā. Has a known silicone allergy or sensitivity
ā. Use of investigational drug or device within four weeks prior to study entry that may interfere with this study.
ā. Any medication deemed by the Investigator to potentially interfere with the study treatment
What they're measuring
1
Change in the number of days in which bacterial concentrations are greater than 10^5 CFU/mL in coated catheters, as compared to uncoated control catheters