Title: Clinical Evaluation, Development and Commercialisation of an Antimicrobial – Impregnated Catheter Against Peritonitis (The CAP Study)
Funder: Department of Health and Social Care

Abstract: 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.

Lay abstract: Peritoneal dialysis (PD) is a type of dialysis that can be used to treat people with kidney failure. In order to perform PD, a silicone tube is placed with one end in the abdominal cavity and the other end exiting through the skin. Fluid is run into the abdomen via the tube and then drained out again after 1-4 hours. This process is repeated multiple times per day. While the fluid is in the abdomen, toxins and other waste chemicals move from the body into the fluid and are then removed when the fluid is drained out. In this way, PD partially replaces kidney function. Infection related to the tube is the most common risk associated with PD. This may be mild if it affects only the skin, but can be severe if the infection spreads to the abdominal cavity. Infection in the abdominal cavity is called peritonitis, and may cause severe pain and even life-threatening sepsis. This requires urgent treatment with antibiotics and often admission to hospital. In severe cases, the PD tube has to be removed to treat the infection. At present, the only measures available to prevent PD tube infections are careful hygiene when handling the tube and antibiotics given before the tube is placed, or if there is any concern that the tube has been contaminated. Despite these measures, peritonitis is one of the most common causes of people having to stop PD and change to another form of dialysis that involves direct filtration of the blood (haemodialysis). Frequent use of antibiotics may also cause the bacteria that cause peritonitis to become resistant to antibiotics. There is therefore an urgent need to develop new ways to prevent PD tube infections. In this project, we propose to test a PD tube that has had three different antibiotics introduced into the silicone. Similar tubes have been used in patients who have a particular type of brain surgery, and in these patients the risk of infection was reduced by 60%. The same technology is also being tested for urine tubes that are placed in the bladder. We will study 40 people needing PD who will have the antibiotic-treated tubes placed as part of their normal care. In this project we will focus on checking whether the tubes are safe to use and, importantly, are acceptable to patients. We will also check whether the tubes are associated with any increase in bacteria that are resistant to antibiotics. The information from this study will be used to apply for permission to use the tubes more widely and to prepare for a bigger study to test how effective the tubes are at reducing infection rates.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: INFECTION