Clinical trial NCT04461262: The Impact Of A Catheter Coating On Clinical Bacteriuria
Official title: A Prospective Multicentre Randomized Study To Assess The Impact Of A Catheter Coating On Clinical Bacteriuria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bacteriuria
Lead sponsor: Camstent Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-08
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Require insertion or exchange of a catheter as a component of their routine clinical care as per hospital guidelines
2. Patients aged 18+ years will be eligible for the study.
3. Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.

Exclusion Criteria:

1. Patients that have or recently (within 3 weeks) had a urinary catheter and displays symptoms of current urinary tract infection.
2. Pregnant or Breastfeeding.
3. Patients with a potentially immunocompromised conditions (HIV)
4. Has a known silicone allergy or sensitivity
5. Use of investigational drug or device within four weeks prior to study entry that may interfere with this study.
6. Any medication deemed by the Investigator to potentially interfere with the study treatment
7. Participation in any other clinical study.
8. Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy

Primary outcomes:
measure: 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
timeFrame: 1 Year
Secondary outcomes:
measure: Change in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls
timeFrame: 1 Year
measure: Change in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls
timeFrame: 1 Year
measure: Patient Reported Outcomes (PRO)
timeFrame: 1 Year
Other outcomes:
Locations:
city: Buckingham
country: United Kingdom
facility: Stoke Mandeville Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: London
country: United Kingdom
facility: Royal National Orthopaedic Hospital
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospital
Study officials:
affiliation: Camstent Ltd.
name: Prital Patel
role: STUDY_DIRECTOR
References: