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 (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05137314

Collaborator

Department of Health and Human Services (U.S. Fed), Wellcome Trust (Other)

Enrollment

Locations

Arms

21.1

Anticipated Duration (Months)

3.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to learn about the safety and effects of PLG0206 for treating acute periprosthetic joint infections (PJI) in conjunction with the DAIR (debridement, antibiotics and implant retention) surgical procedure for patients with acute 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 acute 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 Design

Study Type:

Interventional

Anticipated Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Open-Label, Dose-EscalatingOpen-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 :

Mar 31, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

The percentage of treatment emergent AEs [approximately 1 year]
the safety and tolerability of PLG0206 administered via an irrigation solution for the treatment of an acute PJI occurring after TKA during DAIR.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with well-fixed prosthesis;
Patients who have preoperative diagnosis of TKA-PJI ongoing no more than 6 weeks prior to study drug administration

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;
Presence of a sinus tract(s) at screening;
Patients on chronic antibiotic therapy within 1 month of diagnosis of the PJI 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gulfcoast Research	Sarasota	Florida	United States	34232
2	LifeBridge	Baltimore	Maryland	United States	21215
3	Rothman	Philadelphia	Pennsylvania	United States	19107
4	WVU	Morgantown	West Virginia	United States	26501

Sponsors and Collaborators

Peptilogics
Department of Health and Human Services
Wellcome Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peptilogics

ClinicalTrials.gov Identifier:

NCT05137314

Other Study ID Numbers:

PLG0206-PJI-101

First Posted:

Nov 30, 2021

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peptilogics

PJI

knee infection

Additional relevant MeSH terms:

Infections

Communicable Diseases

Arthritis, Infectious

Study Results

No Results Posted as of Jul 20, 2022