Thanks to the collaboration between Leeds Teaching Hospitals, the University of Leeds, NIHR Clinical Research Facility: Leeds, and NIHR Biomedical Research Centre: Leeds, a clinical trial of a new product to treat Prosthetic Joint Infection (PJI) has treated the first three patients outside the USA within 25 days of recruitment.
RETAIN is a global phase 2/3 double-blind clinical trial of an investigational antimicrobial peptide, zaloganan, designed by US firm Peptilogics to treat PJI. While PJI affects about two percent of joint replacements, it can cause significant problems for patients and often requires repeated surgeries to clean out the infection and replace the artificial joint.
The trial recruited patients who had developed PJI after a knee replacement. Patients are treated with zaloganan or the standard treatment as part of the surgical procedure for PJI. The trial tests whether zaloganan can break down the bacterial biofilm on the artificial joint that protects the infection against standard antibiotics and which makes PJI so difficult to treat.
Professor Hemant Pandit, workstream lead for surgical technology at the NIHR Biomedical Research Centre: Leeds, Professor of Orthopaedic Surgery at the University of Leeds, and Honorary Consultant Orthopaedic Surgeon at Leeds Teaching Hospitals NHS Trust, said: “While the vast majority of knee replacement surgeries help patients move more freely and live with less pain, prosthetic joint infection is a very serious complication that can require repeated surgeries with increased risk of mortality in the most extreme cases. The diagnosis and optimal management of PJI remains challenging to surgeons, and the condition often leaves behind permanent and life-changing effects that negatively impact the patient’s limb function and overall quality of life.”
Mr Jeya Palan, Consultant Orthopaedic Surgeon and Honorary Senior Clinical Lecturer at the University of Leeds, and co-investigator on the RETAIN trial, said: “PJI can be clinically challenging and can require multiple procedures and have unpredictable outcomes. Finding new clinical practices and options for successful treatment of this serious condition is vital to improving the outcome for patients.”
Led by Investigators, Professor Pandit and Mr Palan, Leeds Teaching Hospitals is one of 15 sites in the UK taking part in the RETAIN trial.
Peptilogics is a clinical stage biotech company dedicated to curing and preventing medical device-related infections (MDRI). More information about the RETAIN trial can be found on the Peptilogics website.