The University of Cincinnati has enrolled the first patients in a new clinical trial that will test the effectiveness of an investigational drug for prosthetic joint infections (PJI).
T. Toan Le, MD, professor in the Department of Orthopedic Surgery at the College of Medicine, has now enrolled two patients in Peptilogics’ RETAIN trial.
About 5 million joint replacements are performed each year in the United States and Europe. Peptilogics, a surgical therapy company, develops therapies to prevent and treat medical device-related infections (MDRIs), such as prosthetic joint infections and other joint replacement infections.
“In about 2% to 3% of these cases, the prosthetic joints can become infected,” Le said. A biofilm forms on the surface of the joint implant, created by bacteria that prevents cleaning, antibiotics and the immune system from eliminating the infection. The condition can appear immediately after surgery or even years later.
Biofilm is the leading cause of infections associated with medical devices, and no approved treatment has ever been designed to target it.”
Jonathan Steckbeck, PhD, CEO of Peptilogics
The current standard of care for PJI involves a two-stage revision surgery to remove the infected prosthesis. A spacer is inserted and later replaced with a new prosthetic joint. The procedure carries risks and has a failure rate of up to 25%, according to Peptilogics.
The window for debridement, antibiotics, and implant retention (DAIR) is limited to approximately two weeks after symptoms first appear, or within the first month of the initial procedure. Symptoms may include pain, drainage, swelling and warmth in the affected joint.
RETAIN is a randomized, double-blind, placebo-controlled, multicenter trial testing a biofilm-penetrating peptide solution in patients undergoing DAIR for the treatment of PJI after total knee arthroplasty and the prevention of infection recurrence.
“Once the cleaning is complete, we will use the peptide solution to irrigate the site of infection, leaving it in place on the prosthetic joint for about 15 minutes toward the end of the operation,” Le said. In the trial, half the patients will receive the peptide solution and the other half will receive a saline placebo.
“If this trial is successful, it could make it much easier for orthopedic surgery patients to manage infection and avoid two-stage revision surgery,” Le said. The peptide solution could also extend the treatment window beyond just two weeks.
The trial is expected to enroll 240 patients at up to 50 clinical sites. Each patient will be monitored for persistent infection or recurrence for one year through blood tests and clinic visits, phone calls or virtual visits.
“It’s a very well-designed clinical trial with excellent support for all sites,” Le said.
