The Impact Of A Catheter Coating On Clinical Bacteriuria

Last updated: December 27, 2022
Sponsor: Camstent Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04461262
Cam-Cath-001
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  1. Require insertion or exchange of a catheter as a component of their routine clinicalcare 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 complywith study procedures and visits.

Exclusion

Exclusion Criteria:

  1. Patients that have or recently (within 3 weeks) had a urinary catheter and displayssymptoms 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 mayinterfere with this study.
  6. Any medication deemed by the Investigator to potentially interfere with the studytreatment
  7. Participation in any other clinical study.
  8. Has a known bloodstream infection or an infection that requires prolonged antibiotictherapy

Study Design

Total Participants: 272
Study Start date:
April 27, 2021
Estimated Completion Date:
October 31, 2024

Connect with a study center

  • Stoke Mandeville Hospital

    Buckingham,
    United Kingdom

    Active - Recruiting

  • Addenbrookes Hospital

    Cambridge,
    United Kingdom

    Active - Recruiting

  • Royal National Orthopaedic Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Norfolk & Norwich University Hospital

    Norwich,
    United Kingdom

    Active - Recruiting

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