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)
Peptilogics
Summary
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.
Description
This study is designed to assess the efficacy and safety of PLG0206 administered intraoperatively by local irrigation to participants undergoing a DAIR procedure for treatment of Prosthetic Joint Infection (PJI) occurring after total knee arthroplasty (TKA), also known as knee joint replacement. Eligible participants will undergo a DAIR procedure according to the treating hospital's standard of care (SOC). Participant eligibility will be based on clinical and diagnostic assessments, including laboratory results. Once debridement during DAIR is complete, the Investigator will follow a standar…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female participants age between 18 and \<80 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) * A single DAIR procedure is indicated as treatment of PJI * Agree to use contraceptives if of childbearing potential Exclusion Criteria: * Loose prosthesis or surgical treatment planned for removal of well-fixed, nonmodular implants * Anticipated to require an…
Interventions
- DrugPLG0206
PLG0206 Solution
- DrugPlacebo
Placebo
Locations (8)
- Clinical Trial SiteSarasota, Florida
- Clinical Trial SiteTamarac, Florida
- Clinical Trial SiteBaltimore, Maryland
- Clinical Trial SiteBoston, Massachusetts
- Clinical Trial SiteCincinnati, Ohio
- Clinical Trial SiteColumbus, Ohio