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

Joint Infection Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05137314
• Other study ID #: PLG0206-PJI-101
• Status: Recruiting
• Phase: Phase 1
• Start date: March 31, 2022
• Est. completion date: January 2024

Study information

• Verified date: December 2022
• Source: Peptilogics
• Contact: David Huang, MD
• Phone: (936) 577-5770
• Email: david.huang[@]peptilogics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infections
• Joint Infection

Intervention

Drug:
• PLG0206
PLG0206 is an engineered antibacterial peptide (EAP)

Locations

Country	Name	City	State
United States	LifeBridge	Baltimore	Maryland
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Memorial Hermann Hospital	Houston	Texas
United States	Michael E. DeBakey VA Medical Center	Houston	Texas
United States	WVU	Morgantown	West Virginia
United States	NYU Langone Orthopedic Hospital	New York	New York
United States	Stanford Hospital	Palo Alto	California
United States	Rothman	Philadelphia	Pennsylvania
United States	University of Utah Orthopaedic Center	Salt Lake City	Utah
United States	Gulfcoast Research	Sarasota	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Peptilogics	Department of Health and Human Services, Wellcome Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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