Clinical trial NCT05137314: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Joint Infection
Keywords: PJI
knee infection
Lead sponsor: Peptilogics
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
name: Wellcome Trust
First posted: 2021-11-30
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Open-Label, Dose-Escalating
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The percentage of treatment emergent AEs
timeFrame: approximately 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital
state: California
city: Sarasota
country: United States
facility: Gulfcoast Research
state: Florida
city: Baltimore
country: United States
facility: LifeBridge
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: NYU Langone Orthopedic Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Rothman
state: Pennsylvania
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
city: Morgantown
country: United States
facility: WVU
state: West Virginia
Study officials:
References: