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

• ClinicalTrials.gov Identifier: NCT05137314
• Recruitment Status: Recruiting
• First Posted: November 30, 2021
• Last Update Posted: December 22, 2022
• Sponsor: Peptilogics
• Collaborators: Department of Health and Human Services; Wellcome Trust
• Information provided by (Responsible Party): Peptilogics

Study Description

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) .

Condition or disease	Intervention/treatment	Phase
Joint Infection	Drug: PLG0206	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Open-Label, Dose-Escalating
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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)
• Actual Study Start Date: March 31, 2022
• Estimated Primary Completion Date: January 2024
• Estimated Study Completion Date: January 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: 3 mg/mL PLG0206; administered intraoperatively by local irrigation	Drug: PLG0206; PLG0206 is an engineered antibacterial peptide (EAP)
Experimental: 10 mg/mL PLG0206; administered intraoperatively by local irrigation	Drug: PLG0206; PLG0206 is an engineered antibacterial peptide (EAP)

Outcome Measures

Primary Outcome Measures :

1. The percentage of treatment emergent AEs [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 79 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: David Huang, MD; (936) 577-5770; david.huang@peptilogics.com

Locations

United States, California

Stanford Hospital; Recruiting

Palo Alto, California, United States, 94305

United States, Florida

Gulfcoast Research; Recruiting

Sarasota, Florida, United States, 34232

United States, Maryland

LifeBridge; Recruiting

Baltimore, Maryland, United States, 21215

United States, Massachusetts

Brigham & Women's Hospital; Recruiting

Boston, Massachusetts, United States, 02115

United States, New York

NYU Langone Orthopedic Hospital; Recruiting

New York, New York, United States, 10003

United States, Ohio

Cleveland Clinic; Recruiting

Cleveland, Ohio, United States, 44106

Ohio State University; Recruiting

Columbus, Ohio, United States, 43203

United States, Pennsylvania

Rothman; Recruiting

Philadelphia, Pennsylvania, United States, 19107

United States, Texas

Memorial Hermann Hospital; Recruiting

Houston, Texas, United States, 77030

Michael E. DeBakey VA Medical Center; Recruiting

Houston, Texas, United States, 77030

United States, Utah

University of Utah Orthopaedic Center; Recruiting

Salt Lake City, Utah, United States, 44106

United States, West Virginia

WVU; Recruiting

Morgantown, West Virginia, United States, 26501

Sponsors and Collaborators

Peptilogics

Department of Health and Human Services

Wellcome Trust

More Information

• Responsible Party: Peptilogics
• ClinicalTrials.gov Identifier: NCT05137314
• Other Study ID Numbers: PLG0206-PJI-101
• First Posted: November 30, 2021
• Last Update Posted: December 22, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peptilogics:

PJI; knee infection

Additional relevant MeSH terms:

Infections; Communicable Diseases; Arthritis, Infectious; Disease Attributes; Pathologic Processes; Arthritis; Joint Diseases; Musculoskeletal Diseases