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

December 21, 2022 updated by: Peptilogics

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)

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) .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Recruiting
        • Stanford hospital
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Gulfcoast Research
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • LifeBridge
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham & Women's Hospital
    • New York
      • New York, New York, United States, 10003
        • Recruiting
        • NYU Langone Orthopedic Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43203
        • Recruiting
        • Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Rothman
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Memorial Hermann Hospital
      • Houston, Texas, United States, 77030
        • Recruiting
        • Michael E. DeBakey VA Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 44106
        • Recruiting
        • University of Utah Orthopaedic Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26501
        • Recruiting
        • WVU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peptilogics

Collaborators

Wellcome Trust
Department of Health and Human Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2022

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

November 29, 2021

First Posted (Actual)

November 30, 2021

Study Record Updates

Last Update Posted (Estimate)

December 22, 2022

Last Update Submitted That Met QC Criteria

December 21, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLG0206-PJI-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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