Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty

Last updated: May 12, 2026
Sponsor: Peptilogics
Overall Status: Active - Recruiting

Phase

2/3

Condition

N/A

Treatment

PLG0206

Placebo

Clinical Study ID

NCT07214311
PLG0206-PJI-300
  • Ages 18-80
  • All Genders

Study Summary

The goal of this clinical trial is to evaluate whether the investigational drug PLG0206 can help reduce recurrence of infection in adults who have undergone total knee replacement and are receiving a DAIR (Debridement, Antibiotics, and Implant Retention) surgical procedure to treat a Prosthetic Joint Infection (PJI). The study will also assess the safety of PLG0206 when used as an irrigation solution during the DAIR procedure.

Participants will receive either PLG0206 or a placebo (an inactive substance that looks like the investigational drug), in addition to standard of care treatments. All participants will be monitored for approximately one year following their DAIR procedure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female participants age between 18 and <80 years

  • Able to provide informed consent, geographically stable, and able to comply with therequired follow-up visits

  • Suspected or confirmed PJI of the knee

  • Well-fixed and positioned prosthesis and good condition of surrounding soft tissue (no sinus tract)

  • A single DAIR procedure is indicated as treatment of PJI

  • Agree to use contraceptives if of childbearing potential

Exclusion

Exclusion Criteria:

  • Loose prosthesis or surgical treatment planned for removal of well-fixed, nonmodularimplants

  • Anticipated to require antibiotic therapy for >6 months after DAIR procedure

  • Infection spread beyond the affected knee joint (e.g., osteomyelitis)

  • History of a prior PJI of the affected knee

  • Two or more prior revisions in the affected joint

  • Epithelialized sinus tract with evidence of communication to the joint orvisualization of prosthesis

  • Diabetes mellitus and with an A1c ≥9%

  • History of malignant disease and having received immunosuppressive therapy,radiation therapy, or chemotherapy within the past year

  • Known immunodeficiency (e.g., splenectomy; sickle cell anemia; humanimmunodeficiency virus [HIV] with recent CD4 count <200 cells/mm3; or primaryhumoral, bone marrow, or other transplantation)

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: PLG0206
Phase: 2/3
Study Start date:
February 03, 2026
Estimated Completion Date:
September 30, 2028

Study Description

This study is designed to assess the efficacy and safety of PLG0206 administered intraoperatively by local irrigation to participants undergoing a DAIR procedure for treatment of Prosthetic Joint Infection (PJI) occurring after total knee arthroplasty (TKA), also known as knee joint replacement.

Eligible participants will undergo a DAIR procedure according to the treating hospital's standard of care (SOC). Participant eligibility will be based on clinical and diagnostic assessments, including laboratory results.

Once debridement during DAIR is complete, the Investigator will follow a standardized irrigation protocol, with the final irrigation step being administration of a single dose of blinded study drug (PLG0206 or matching placebo). The study drug will be administered as a single intra-articular irrigation.

Following study drug administration, all participants will receive standard post-operative care per institutional guidelines and will be discharged from the hospital in accordance with local standards. Participants may receive IV/oral antimicrobial therapy, as part of post-operative SOC.

Participants will be monitored for safety and signs of PJI recurrence or persistent infection for 365 days post study drug administration. After hospital discharge, study visits will occur in-clinic on Days 14, 90, and 365, and on Days 30, 180, and 270 via a telephone or virtual visit.

Connect with a study center

  • Clinical Trial Site

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Clinical Trial Site

    Tamarac, Florida 33321
    United States

    Active - Recruiting

  • Clinical Trial Site

    Tamarac 4174738, Florida 4155751 33321
    United States

    Site Not Available

  • Clinical Trial Site

    Baltimore, Maryland 21215
    United States

    Active - Recruiting

  • Clinical Trial Site

    Baltimore 4347778, Maryland 4361885 21215
    United States

    Site Not Available

  • Clinical Trial Site

    Boston, Massachusetts 02120
    United States

    Active - Recruiting

  • Clinical Trial Site

    Boston 4930956, Massachusetts 6254926 02120
    United States

    Site Not Available

  • Clinical Trial Site

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

  • Clinical Trial Site

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Clinical Trial Site

    Cincinnati 4508722, Ohio 5165418 45267
    United States

    Site Not Available

  • Clinical Trial Site

    Columbus 4509177, Ohio 5165418 43210
    United States

    Site Not Available

  • Clinical Trial Site

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • Clinical Trial Site

    Edinburg, Texas 78539
    United States

    Active - Recruiting

  • Clinical Trial Site

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

  • Clinical Trial Site

    Morgantown 4815352, West Virginia 4826850 26506
    United States

    Site Not Available

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