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

Last updated: May 19, 2025
Sponsor: Peptilogics
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

PLG0206

Clinical Study ID

NCT05137314
PLG0206-PJI-101
  • Ages 18-79
  • All Genders

Study 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) .

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with well-fixed prosthesis;

  • Patients who have a pre- or intra-operative diagnosis of TKA-PJI

Exclusion

Exclusion Criteria:

  • Patients for whom a DAIR procedure is not indicated;

  • Patients with loose prosthesis and/or surgical treatment requiring removal ofwell-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

Total Participants: 14
Treatment Group(s): 1
Primary Treatment: PLG0206
Phase: 1
Study Start date:
March 31, 2022
Estimated Completion Date:
March 19, 2024

Study 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.

Connect with a study center

  • Stanford Hospital

    Palo Alto, California 94305
    United States

    Site Not Available

  • Gulfcoast Research

    Sarasota, Florida 34232
    United States

    Site Not Available

  • LifeBridge

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • Brigham & Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • NYU Langone Orthopedic Hospital

    New York, New York 10003
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43203
    United States

    Site Not Available

  • Rothman

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Memorial Hermann Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Michael E. DeBakey VA Medical Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Utah Orthopaedic Center

    Salt Lake City, Utah 44106
    United States

    Site Not Available

  • WVU

    Morgantown, West Virginia 26501
    United States

    Site Not Available

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