Clinical trial NCT04658719: A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria
Official title: 'A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria.'
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bacteriuria
Lead sponsor: Camstent Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria when compared to an uncoated 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 allocated to either a coated catheter or an uncoated catheter. Participants will be assigned to receive trial treatment until the catheter has been removed, 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:

* Require insertion or exchange of a urinary catheter in a suprapubic position as a component of their routine clinical care as per 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.2. Patients that have asymptomatic infection (if required may need a blood test to confirm)
* 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

Primary outcomes:
measure: The primary efficacy endpoint is a decrease in the number of days in which bacterial concentrations are greater than 105 CFU/mL in coated catheters, as compared to uncoated control catheters
timeFrame: 1 Year
Secondary outcomes:
measure: • Patient Reported Outcomes (PRO)
timeFrame: 1 Year
measure: • Reduction in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls
timeFrame: 1 Year
measure: • Reduction in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls
timeFrame: 1 Year
measure: • Reduction of number of cases experiencing blockage in coated catheters vs. uncoated controls
timeFrame: 1 Year
measure: • Reduction in Biofilm
timeFrame: 1 Year
measure: • Reduction in site infection
timeFrame: 1 Year
Other outcomes:
Locations:
Study officials:
References: