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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)

Primary Purpose

Joint Infection

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PLG0206
Sponsored by
Peptilogics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Joint Infection focused on measuring PJI, knee infection

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford HospitalRecruiting
  • Gulfcoast ResearchRecruiting
  • LifeBridgeRecruiting
  • Brigham & Women's HospitalRecruiting
  • NYU Langone Orthopedic HospitalRecruiting
  • Cleveland ClinicRecruiting
  • Ohio State UniversityRecruiting
  • RothmanRecruiting
  • Memorial Hermann HospitalRecruiting
  • Michael E. DeBakey VA Medical CenterRecruiting
  • University of Utah Orthopaedic CenterRecruiting
  • WVURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

3 mg/mL PLG0206

10 mg/mL PLG0206

Arm Description

administered intraoperatively by local irrigation

administered intraoperatively by local irrigation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2021
Last Updated
December 21, 2022
Sponsor
Peptilogics
Collaborators
Department of Health and Human Services, Wellcome Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05137314
Brief Title
Study in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peptilogics
Collaborators
Department of Health and Human Services, Wellcome Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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) .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Infection
Keywords
PJI, knee infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Open-Label, Dose-Escalating
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3 mg/mL PLG0206
Arm Type
Experimental
Arm Description
administered intraoperatively by local irrigation
Arm Title
10 mg/mL PLG0206
Arm Type
Experimental
Arm Description
administered intraoperatively by local irrigation
Intervention Type
Drug
Intervention Name(s)
PLG0206
Intervention Description
PLG0206 is an engineered antibacterial peptide (EAP)
Primary Outcome Measure Information:
Title
The percentage of treatment emergent AEs
Description
the safety and tolerability of PLG0206 administered via an irrigation solution for the treatment of a PJI occurring after TKA during DAIR.
Time Frame
approximately 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Huang, MD
Phone
(936) 577-5770
Email
david.huang@peptilogics.com
Facility Information:
Facility Name
Stanford Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
Gulfcoast Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Individual Site Status
Recruiting
Facility Name
LifeBridge
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Individual Site Status
Recruiting
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Orthopedic Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Individual Site Status
Recruiting
Facility Name
Rothman
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Utah Orthopaedic Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
WVU
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26501
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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