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

Peptilogics14 enrolled

Overview

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) .

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Joint Infection

Interventions

PLG0206DRUG

PLG0206 is an engineered antibacterial peptide (EAP)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (12)

Stanford Hospital

Palo Alto, California, United States

Gulfcoast Research

Sarasota, Florida, United States

LifeBridge

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: approximately 1 year

Data from ClinicalTrials.gov

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