NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Peptilogics
Conditions: Prosthetic-joint Infection
Interventions: PLG0206, Placebo
Countries: United States, United Kingdom
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.
Sex: ALL
Age: 18 Years to 80 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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 antibiotic therapy for \>6 months after DAIR procedure * Infection spread beyond the affected knee joint (e.g., osteomyelitis) * History of a prior PJI of the affected knee * Two or more prior revisions in the affected joint * Epithelialized sinus tract with evidence of communication to the joint or visualization of prosthesis * Diabetes mellitus and with an A1c ≥9% * History of malignant disease and having received immunosuppressive therapy, radiation therapy, or chemotherapy within the past year * Known immunodeficiency (e.g., splenectomy; sickle cell anemia; human immunodeficiency virus \[HIV\] with recent CD4 count \<200 cells/mm3; or primary humoral, bone marrow, or other transplantation)
- Sarasota, Florida, United States
- Tamarac, Florida, United States
- Shreveport, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Leland, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Dallas, Texas, United States
- Edinburg, Texas, United States
- Salt Lake City, Utah, United States
- Morgantown, West Virginia, United States
- Leeds, West Yorkshire, United Kingdom