Study in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Joint Infection

Intervention / Treatment
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* Drug: PLG0206


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Open-Label, Dose-Escalating
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 mg/mL PLG0206<br>administered intraoperatively by local irrigation | Drug: PLG0206<br>* PLG0206 is an engineered antibacterial peptide (EAP)<br>|
| Experimental: 10 mg/mL PLG0206<br>administered intraoperatively by local irrigation | Drug: PLG0206<br>* PLG0206 is an engineered antibacterial peptide (EAP)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of treatment emergent AEs | the safety and tolerability of PLG0206 administered via an irrigation solution for the treatment of a PJI occurring after TKA during DAIR. | approximately 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PJI, knee infection