Phase
Condition
N/ATreatment
PLG0206
Placebo
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female participants age between 18 and <80 years
Able to provide informed consent, geographically stable, and able to comply with therequired follow-up visits
Suspected or confirmed PJI of the knee
Well-fixed and positioned prosthesis and good condition of surrounding soft tissue (no sinus tract)
A single DAIR procedure is indicated as treatment of PJI
Agree to use contraceptives if of childbearing potential
Exclusion
Exclusion Criteria:
Loose prosthesis or surgical treatment planned for removal of well-fixed, nonmodularimplants
Anticipated to require antibiotic therapy for >6 months after DAIR procedure
Infection spread beyond the affected knee joint (e.g., osteomyelitis)
History of a prior PJI of the affected knee
Two or more prior revisions in the affected joint
Epithelialized sinus tract with evidence of communication to the joint orvisualization of prosthesis
Diabetes mellitus and with an A1c ≥9%
History of malignant disease and having received immunosuppressive therapy,radiation therapy, or chemotherapy within the past year
Known immunodeficiency (e.g., splenectomy; sickle cell anemia; humanimmunodeficiency virus [HIV] with recent CD4 count <200 cells/mm3; or primaryhumoral, bone marrow, or other transplantation)
Study Design
Study Description
Connect with a study center
Clinical Trial Site
Sarasota, Florida 34239
United StatesActive - Recruiting
Clinical Trial Site
Tamarac, Florida 33321
United StatesActive - Recruiting
Clinical Trial Site
Tamarac 4174738, Florida 4155751 33321
United StatesSite Not Available
Clinical Trial Site
Baltimore, Maryland 21215
United StatesActive - Recruiting
Clinical Trial Site
Baltimore 4347778, Maryland 4361885 21215
United StatesSite Not Available
Clinical Trial Site
Boston, Massachusetts 02120
United StatesActive - Recruiting
Clinical Trial Site
Boston 4930956, Massachusetts 6254926 02120
United StatesSite Not Available
Clinical Trial Site
Cincinnati, Ohio 45267
United StatesActive - Recruiting
Clinical Trial Site
Columbus, Ohio 43210
United StatesActive - Recruiting
Clinical Trial Site
Cincinnati 4508722, Ohio 5165418 45267
United StatesSite Not Available
Clinical Trial Site
Columbus 4509177, Ohio 5165418 43210
United StatesSite Not Available
Clinical Trial Site
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
Clinical Trial Site
Edinburg, Texas 78539
United StatesActive - Recruiting
Clinical Trial Site
Morgantown, West Virginia 26506
United StatesActive - Recruiting
Clinical Trial Site
Morgantown 4815352, West Virginia 4826850 26506
United StatesSite Not Available

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