Status:
RECRUITING
Evaluation 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 Knee Arthroplasty
Lead Sponsor:
Peptilogics
Conditions:
Prosthetic-joint Infection
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed 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 Infe...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT07214311
Start Date
December 1 2025
End Date
September 1 2028
Last Update
January 2 2026
Active Locations (3)
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1
Clinical Trial Site
Baltimore, Maryland, United States, 21215
2
Clinical Trial Site
Boston, Massachusetts, United States, 02120
3
Clinical Trial Site
Columbus, Ohio, United States, 43210