The goal of this clinical trial is to evaluate whether the investigational drug PLG0206 can help reduce recurrence of infection in adults who have undergone total knee replacement and are receiving a DAIR (Debridement, Antibiotics, and Implant Retention) surgical procedure to treat a Prosthetic Joint Infection (PJI). The study will also assess the safety of PLG0206 when used as an irrigation solution during the DAIR procedure.
Participants will receive either PLG0206 or a placebo (an inactive substance that looks like the investigational drug), in addition to standard of care treatments. All participants will be monitored for approximately one year following their DAIR procedure.
Male or female participants age between 18 and <86 years
Able to provide informed consent, geographically stable, and able to comply with the required follow-up visits
Suspected or confirmed PJI of the knee
Well-fixed and positioned prosthesis and good condition of surrounding soft tissue (no sinus tract)
Loose prosthesis or surgical treatment planned for removal of well-fixed, nonmodular implants
Anticipated to require antibiotic therapy for >6 months after DAIR procedure
Infection spread beyond the affected knee joint (e.g., osteomyelitis)
History of a prior confirmed PJI of the affected knee, including prior DAIR or revision surgery for PJI
Parallel
PLG0206
DrugPLG0206 Solution
Placebo
DrugPlacebo
Reduction in Treatment Failure Post DAIR
Proportion of participants with PJI treatment failure following DAIR
Reduction Rate of PJI-related Surgical Intervention
Proportion of participants with PJI requiring a PJI-related surgical intervention following DAIR
Safety of PLG0206
Evaluation of adverse events
Survival
Evaluation of PJI-related mortality rate
Efficacy of PLG0206 on Clinical Outcome
Evaluate the rate of PJI treatment failure at specific time points
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