A Prospective Multicentre Randomized Study To Assess The Impact Of A Catheter Coating On Clinical Bacteriuria
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 272
- Locations
- 4
- Primary Endpoint
- 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
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Urine samples will not state which arm the participant is in
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
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
Time Frame: 1 Year
Secondary Outcomes
- Change in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls(1 Year)
- Patient Reported Outcomes (PRO)(1 Year)
- Change in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls(1 Year)