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

NCT05137314 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PLG0206-PJI-101
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 12

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) .

Conditions

Joint Infection

Keywords

PJI; knee infection

Outcome Measures

Primary Outcomes (1)

• 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.

  approximately 1 year

Study Arms (2)

3 mg/mL PLG0206

EXPERIMENTAL

administered intraoperatively by local irrigation

Drug: PLG0206

10 mg/mL PLG0206

EXPERIMENTAL

administered intraoperatively by local irrigation

Drug: PLG0206

Interventions

PLG0206 DRUG

PLG0206 is an engineered antibacterial peptide (EAP)

10 mg/mL PLG0206; 3 mg/mL PLG0206

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with well-fixed prosthesis;
• Patients who have a pre- or intra-operative diagnosis of TKA-PJI

You may not qualify if:

• 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

Sponsors & Collaborators

• Peptilogics: lead
• Biomedical Advanced Research and Development Authority: collaborator
• Wellcome Trust: collaborator

Study Sites (12)

Stanford Hospital

Palo Alto, California, 94305, United States

Location

Gulfcoast Research

Sarasota, Florida, 34232, United States

Location

LifeBridge

Baltimore, Maryland, 21215, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

NYU Langone Orthopedic Hospital

New York, New York, 10003, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44106, United States

Location

Ohio State University

Columbus, Ohio, 43203, United States

Location

Rothman

Philadelphia, Pennsylvania, 19107, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

University of Utah Orthopaedic Center

Salt Lake City, Utah, 44106, United States

Location

WVU

Morgantown, West Virginia, 26501, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-Label, Dose-Escalating

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 30, 2021
• Study Start: March 31, 2022
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)