*RETAIN
Research type
Research Study
Full title
RETAIN: A Phase 2/3 Randomized, Placebo-Controlled Study to Evaluate the Efficacy of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Total Knee Arthroplasty (TKA)
IRAS ID
1013306
Contact name
Ellie Hershberger
Contact email
Sponsor organisation
Peptilogics, Inc.
Clinicaltrials.gov Identifier
Research summary
This research study will include participants who have developed a periprosthetic joint infection (PJI) after a total knee replacement. The goal of this study is to see if the drug PLG0206 can help people with PJI (an infection around an artificial knee joint) after knee replacement surgery. PLG0206 is a liquid that kills bacteria. It is used during a Debridement, Antibiotics and Implant Retention (DAIR) procedure. It is a procedure to clean the joint and keep the implant in place. The study will test if rinsing the joint with PLG0206 works better than doing the procedure without it. It will also look at whether PLG0206 can stop the infection from coming back. Another part of the study is to see if PLG0206 is safe and to find out what side effects it may cause. PLG0206 is a new type of peptide, which is a very small protein. Peptides like this are part of the body’s natural defence system. They help fight bacteria and stop infections. PLG0206 is designed to kill bacteria that can cause infections in artificial joints and may help keep these infections from coming back.
During the DAIR procedure for PJI, the joint will be rinsed with either PLG0206 or a placebo. A placebo is a salt-water (saline) solution that looks the same as PLG0206 but has no active medicine in it. The solution (PLG0206 or placebo) will be used to wash the inside of the joint at the end of the surgery.
The participants will first have a Screening Period that can last up to 7 days. After that, on Study Day 1 (the day of surgery), the participant will have the DAIR procedure. At the end of this procedure, the knee will be rinsed with the study drug or placebo. After surgery, the participant will be checked for safety and watched for any signs that the infection is coming back. This follow-up will last up to 12 months (about 1 year) after the participant receives the study drug.REC name
Wales REC 2
REC reference
26/WA/0004
Date of REC Opinion
17 Feb 2026
REC opinion
Further Information Favourable Opinion