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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05137314
Recruitment Status : Recruiting
First Posted : November 30, 2021
Last Update Posted : September 1, 2022
Sponsor:
Collaborators:
Department of Health and Human Services
Wellcome Trust
Information provided by (Responsible Party):
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 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.

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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

Resource links provided by the National Library of Medicine


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)




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05137314


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

Locations
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United States, Florida
Gulfcoast Research Recruiting
Sarasota, Florida, United States, 34232
United States, Maryland
LifeBridge Recruiting
Baltimore, Maryland, United States, 21215
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, 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
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Responsible Party: Peptilogics
ClinicalTrials.gov Identifier: NCT05137314    
Other Study ID Numbers: PLG0206-PJI-101
First Posted: November 30, 2021    Key Record Dates
Last Update Posted: September 1, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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