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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05137314

Enrollment

Registered

2021-11-30

Start date

2022-03-31

Completion date

2024-03-19

Last updated

2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Joint Infection

Keywords

PJI, knee infection

Brief summary

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

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.

Interventions

DRUGPLG0206

PLG0206 is an engineered antibacterial peptide (EAP)

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Open-Label, Dose-Escalating

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026