The University of Cincinnati has enrolled the first patient in a new clinical trial testing the effectiveness of an investigational drug against prosthetic joint infections (PJI).
T. Toan Le, MD, professor of orthopedics at the School of Medicine, has now enrolled two patients in Peptide Logix’s RETAIN trial.
Approximately 5 million joint replacement surgeries are performed in the United States and Europe each year. Peptide Logix, a surgical therapeutics company, develops therapies to prevent and treat medical device-associated infections (MDRIs), such as prosthetic joint infections and other joint replacement infections.
“In about 2% to 3% of these cases, the artificial joint can become infected,” Le said. Biofilms form on the surfaces of joint implants with bacteria that prevent debridement, antibiotics, and the immune system from eradicating the infection. This condition may occur immediately after surgery or several years later.
Biofilms are the root cause of medical device-associated infections, and no approved treatments have been designed to date to target biofilms. ”
Dr. Jonathan Steckbeck, CEO of Peptide Logix
The current standard treatment for PJI involves a two-stage revision surgery to remove the infected prosthesis. A spacer is inserted and then replaced with a new artificial joint. The procedure is risky, with a failure rate of up to 25%, according to Peptidelogics.
The duration of debridement, antibiotics, and implant retention (DAIR) is limited to approximately 2 weeks after symptoms first appear or within 1 month of the initial procedure. Symptoms include pain, drainage, swelling, and warmth in the affected joint.
RETAIN is a randomized, double-blind, placebo-controlled, multicenter trial testing a peptide solution that penetrates biofilms in patients undergoing DAIR to treat PJI after total knee arthroplasty and prevent recurrence of infection.
“Once the debridement is complete, we use a peptide solution to cleanse the infected area and leave it on the artificial joint for about 15 minutes toward the end of the surgery,” Le said. In this trial, half of the patients will receive a peptide solution and the other half will receive a saline placebo.
“If this trial is successful, it may become much easier to treat orthopedic patients, allowing them to manage infections and avoid two-stage revision surgeries,” Le said. Peptide solutions also have the potential to extend the treatment period beyond just two weeks.
The trial is expected to enroll 240 patients at up to 50 clinical sites. Each patient will be monitored for one year for persistent infection or recurrence through blood tests, office visits, phone calls or online visits.
“This is a very well-designed clinical trial with excellent support for all sites,” Le said.
