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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Peptilogics
Study ID
NCT05137314
Phase
PHASE1
Status
Completed

Conditions

  • Joint Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • PLG0206 — DRUG
    PLG0206 is an engineered antibacterial peptide (EAP)

Study Details

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) .

Key Dates

Start date
Mar 31, 2022
Status verified
May 2025
Primary completion
Mar 19, 2024
Completion
Mar 19, 2024

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 3 mg/mL PLG0206
    administered intraoperatively by local irrigation
  • Experimental: 10 mg/mL PLG0206
    administered intraoperatively by local irrigation

Primary Outcome Measure

The percentage of treatment emergent AEs [ Time Frame: approximately 1 year ]

Locations (12)

FacilityCityStateZIPSite coordinators
Stanford HospitalPalo AltoCalifornia94305-
Gulfcoast ResearchSarasotaFlorida34232-
LifeBridgeBaltimoreMaryland21215-
Brigham & Women's HospitalBostonMassachusetts02115-
NYU Langone Orthopedic HospitalNew YorkNew York10003-
Cleveland ClinicClevelandOhio44106-
Ohio State UniversityColumbusOhio43203-
RothmanPhiladelphiaPennsylvania19107-
Memorial Hermann HospitalHoustonTexas77030-
Michael E. DeBakey VA Medical CenterHoustonTexas77030-
University of Utah Orthopaedic CenterSalt Lake CityUtah44106-
WVUMorgantownWest Virginia26501-

Find similar trials in Palo Alto, CA

By research site
Stanford Hospital· Palo Alto, CAGulfcoast Research· Sarasota, FLLifeBridge· Baltimore, MDBrigham & Women's Hospital· Boston, MANYU Langone Orthopedic Hospital· New York, NYCleveland Clinic· Cleveland, OH

Related Studies