Study in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA)
- Registration Number
- NCT05137314
- Lead Sponsor
- Peptilogics
- Brief Summary
The purpose of this study is to learn about the safety and effects of PLG0206 for treating periprosthetic joint infections (PJI) in conjunction with the DAIR (debridement, antibiotics and implant retention) surgical procedure for patients with periprosthetic joint infections (PJI) after total knee arthroplasty (TKA) .
- Detailed Description
Peptilogics, Inc. is developing PLG0206 for the treatment of PJIs. PLG0206 is an engineered antibacterial peptide (EAP) based on naturally-occurring antimicrobial peptides (AMPs). Recent work on PLG0206 has documented that PLG0206 is a highly effective anti-biofilm agent, in addition to its established activity against planktonic staphylococcus, both in vitro and in a murine animal model of PJI.
PLG0206 will be investigated in this study for treatment of PJI in conjunction with the DAIR procedure followed by the 6-week course of antimicrobial therapy that is standard-of-care (SOC) in this indication.
Patients will be followed for approximately 1 year post treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- Patients with well-fixed prosthesis;
- Patients who have a pre- or intra-operative diagnosis of TKA-PJI
- Patients for whom a DAIR procedure is not indicated;
- Patients with loose prosthesis and/or surgical treatment requiring removal of well-fixed, non-modular implants at screening;
- Patients with previous history or presence of osteomyelitis in the index limb;
- Patients who have uncontrolled diabetes mellitus;
- Patients with body mass index >50 kg/m2 at screening;
- Patients who are immunosuppressed;
- Patients who require therapeutic anticoagulation and/or antiplatelet therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description 3 mg/mL PLG0206 PLG0206 administered intraoperatively by local irrigation 10 mg/mL PLG0206 PLG0206 administered intraoperatively by local irrigation
- Primary Outcome Measures
Name Time Method The percentage of treatment emergent AEs approximately 1 year the safety and tolerability of PLG0206 administered via an irrigation solution for the treatment of a PJI occurring after TKA during DAIR.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Stanford Hospital
🇺🇸Palo Alto, California, United States
Gulfcoast Research
🇺🇸Sarasota, Florida, United States
LifeBridge
🇺🇸Baltimore, Maryland, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
NYU Langone Orthopedic Hospital
🇺🇸New York, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Rothman
🇺🇸Philadelphia, Pennsylvania, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Michael E. DeBakey VA Medical Center
🇺🇸Houston, Texas, United States
University of Utah Orthopaedic Center
🇺🇸Salt Lake City, Utah, United States
WVU
🇺🇸Morgantown, West Virginia, United States