Study in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA)
Purpose
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) .
Condition
- Joint Infection
Eligibility
- Eligible Ages
- Between 18 Years and 79 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patients with well-fixed prosthesis; - Patients who have a pre- or intra-operative diagnosis of TKA-PJI
Exclusion Criteria
- 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
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Open-Label, Dose-Escalating
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 3 mg/mL PLG0206 |
administered intraoperatively by local irrigation |
|
|
Experimental 10 mg/mL PLG0206 |
administered intraoperatively by local irrigation |
|
Recruiting Locations
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- Peptilogics
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.