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, a professor in the Department of Orthopaedic Surgery in 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 therapeutics company, develops treatments to prevent and cure medical device-related infections (MDRI) such as prosthetic joint infections and other joint replacement infections.
"In about 2% to 3% of these cases, the prosthetic joints can become infected," said Le. A biofilm forms on the surface of the joint implant, created by bacteria preventing debridement, antibiotics and the immune system from eradicating the infection. The condition can occur soon after surgery or even years later.
Biofilm is the root cause of medical device-related infections, and no approved therapy has ever been designed to target it."
Jonathan Steckbeck, PhD, Peptilogics CEO
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 about two weeks after symptoms first appear or within the first month of the initial procedure. Symptoms can include pain, drainage, swelling and warmth at the affected joint.
RETAIN is a randomized, double-blind, placebo-controlled, multicenter trial testing a peptide solution that penetrates biofilm in patients undergoing DAIR to treat PJI following total knee replacement and prevent infection recurrence.
"Once debridement is complete, we will use the peptide solution to irrigate the infection site, leaving it in place on the prosthetic joint for about 15 minutes toward the end of surgery," said Le. In the trial, half of 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 treating orthopaedic surgery patients to manage infection and avoid the two-stage revision surgery," said Le. The peptide solution could also expand 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 work and clinic visits, phone calls or virtual visits.
"It's a very well-designed clinical trial with excellent support for all sites," said Le.
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