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NCT05137314 | Recruiting | Joint Infection


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

Peptilogics

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

Joint Infection

Intervention/treatment

PLG0206

Phase

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 Type : Interventional
Estimated Enrollment : 14 participants
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
Arm Intervention/treatment

Experimental: 3 mg/mL PLG0206

administered intraoperatively by local irrigation

Drug: PLG0206

Experimental: 10 mg/mL PLG0206

administered intraoperatively by local irrigation

Drug: PLG0206

Ages Eligible for Study: 18 Years to 79 Years
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

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

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, California

Stanford Hospital

Palo Alto, California, United States, 94305

Recruiting

United States, Florida

Gulfcoast Research

Sarasota, Florida, United States, 34232

Recruiting

United States, Maryland

LifeBridge

Baltimore, Maryland, United States, 21215

Recruiting

United States, Massachusetts

Brigham & Women's Hospital

Boston, Massachusetts, United States, 02115

Recruiting

United States, New York

NYU Langone Orthopedic Hospital

New York, New York, United States, 10003

Recruiting

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44106

Recruiting

United States, Ohio

Ohio State University

Columbus, Ohio, United States, 43203

Recruiting

United States, Pennsylvania

Rothman

Philadelphia, Pennsylvania, United States, 19107

Recruiting

United States, Texas

Memorial Hermann Hospital

Houston, Texas, United States, 77030

Recruiting

United States, Texas

Michael E. DeBakey VA Medical Center

Houston, Texas, United States, 77030

Recruiting

United States, Utah

University of Utah Orthopaedic Center

Salt Lake City, Utah, United States, 44106

Recruiting

United States, West Virginia

WVU

Morgantown, West Virginia, United States, 26501

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