Study of PLG0206 to Prevent Recurrent Infection After Knee Replacement Surgery Using DAIR Procedure

What this Trial Is About

Researchers are evaluating the investigational drug PLG0206 to see if it can reduce the recurrence of infection in adults who have had a total knee replacement and are receiving a DAIR Debridement, Antibiotics, and Implant Retention surgical procedure to treat a Prosthetic Joint Infection PJI. This Phase 23 study also aims to assess the safety of using PLG0206 as an irrigation solution during the DAIR surgery. Participants will undergo a DAIR procedure following their hospitals standard care. After debridement, a single dose of either PLG0206 or a placebo will be administered as an intra-articular irrigation during the surgery. Following this, all participants will receive standard post-operative care, including possible intravenous or oral antibiotics. The study drug is given only once during the procedure. Participants will be monitored for safety and any signs of infection recurrence for one year after the study drug administration. Follow-up includes in-clinic visits on Days 14, 90, and 365, along with telephone or virtual visits on Days 30, 180, and 270. Researchers will measure treatment failure, infection recurrence, clinical outcomes, safety, microbiological effects, and changes in function and biomarkers during this period.

Evaluation 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 Knee Arthroplasty