Peptilogics
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) .
Joint Infection
PLG0206
PHASE1
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.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 14 participants |
Masking : | NONE |
Primary Purpose : | TREATMENT |
Official Title : | A Phase 1b Open-Label, Dose-Escalating Study to Evaluate the Safety and Tolerability of PLG0206 in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA) |
Actual Study Start Date : | 2022-03-31 |
Estimated Primary Completion Date : | 2024-01 |
Estimated Study Completion Date : | 2024-01 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 79 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Stanford Hospital
Palo Alto, California, United States, 94305
RECRUITING
Gulfcoast Research
Sarasota, Florida, United States, 34232
RECRUITING
LifeBridge
Baltimore, Maryland, United States, 21215
RECRUITING
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
RECRUITING
NYU Langone Orthopedic Hospital
New York, New York, United States, 10003
RECRUITING
Cleveland Clinic
Cleveland, Ohio, United States, 44106
RECRUITING
Ohio State University
Columbus, Ohio, United States, 43203
RECRUITING
Rothman
Philadelphia, Pennsylvania, United States, 19107
RECRUITING
Memorial Hermann Hospital
Houston, Texas, United States, 77030
RECRUITING
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
RECRUITING
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States, 44106
RECRUITING
WVU
Morgantown, West Virginia, United States, 26501