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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2024-03-19

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) .

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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.

Conditions

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Joint Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Open-Label, Dose-Escalating

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3 mg/mL PLG0206

administered intraoperatively by local irrigation

Group Type EXPERIMENTAL

PLG0206

Intervention Type DRUG

PLG0206 is an engineered antibacterial peptide (EAP)

10 mg/mL PLG0206

administered intraoperatively by local irrigation

Group Type EXPERIMENTAL

PLG0206

Intervention Type DRUG

PLG0206 is an engineered antibacterial peptide (EAP)

Interventions

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PLG0206

PLG0206 is an engineered antibacterial peptide (EAP)

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No