Clinical Evaluation, Development and Commercialisation of an Antimicrobial – Impregnated Catheter Against Peritonitis (The CAP Study)

Research question: Is an antimicrobial peritoneal dialysis (PD) catheter impregnated with rifampicin, sparfloxacin, and triclosan well-tolerated by patients and do these data support future studies of efficacy and commercialisation?

Background: PD is an important treatment modality for people with end-stage kidney disease, with the advantage that it can be performed in the patient s own home.

However, PD-catheter infections are the most common cause of PD access failure and account for 20% of PD patient deaths.

An antimicrobial-impregnated PD catheter has been developed to provide long-term protection against the causative bacteria that cause PD-catheter infections.

Aims: We aim to investigate the tolerability, acceptability, and safety of an antimicrobial-impregnated catheter in people performing PD.

This is supported by four objectives: to develop and evaluate the antimicrobial PD catheter, to complete a clinical evaluation, to embed meaningful PPI throughout, and to develop a commercialisation and NHS adoption strategy. Methods: We will meet the aims and objectives of the project through seven work packages.

Antimicrobial PD catheters will be assessed for quality and biocompatibility. They will be clinically evaluated in 40 adults undergoing elective PD catheter insertion.

Working with Academic Health Sciences Network (AHSN) and the Centre for Healthcare Equipment and Technology Adoption we will develop commercialisation and dissemination strategies.

Timelines: Months 0-9: catheter development and study approvals; Months 9-27: clinical study recruitment; Month 33: clinical study, dissemination plan, and commercialisation plan completion; Month 36: CE-mark ready and final report Impact and Dissemination: The AHSN and PPI group will assist in dissemination of results to relevant stakeholders.

We will work with industry to translate the technology into the NHS and if positive, use the results to support a trial of efficacy.

It is expected that this technology will benefit PD patients by reducing infections and improving quality of life, leading to NHS cost savings.