A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria

Not Applicable

• Conditions: Bacteriuria

• Registration Number: NCT04658719
• Lead Sponsor: Camstent Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-08
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-11
• Study Start: 2021-02
• Primary Completion: 2021-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	1 Year

Secondary Outcome Measures

Name	Time	Method
• Patient Reported Outcomes (PRO)	1 Year
• Reduction in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls	1 Year
• Reduction of number of cases experiencing blockage in coated catheters vs. uncoated controls	1 Year
• Reduction in Biofilm	1 Year
• Reduction in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls	1 Year
• Reduction in site infection	1 Year