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Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty

RecruitingPhase 2, Phase 3Ages 18 Years - 85 YearsAllPeptilogics
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to evaluate whether the investigational drug PLG0206 can help reduce recurrence of infection in adults who have undergone total knee replacement and are receiving a DAIR (Debridement, Antibiotics, and Implant Retention) surgical procedure to treat a Prosthetic Joint Infection (PJI). The study will also assess the safety of PLG0206 when used as an irrigation solution during the DAIR procedure. Participants will receive either PLG0206 or a placebo (an inactive substance that looks like the investigational drug), in addition to standard of care treatments. All participants will be monitored for approximately one year following their DAIR procedure.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male or female participants age between 18 and \<86 years * Able to provide informed consent, geographically stable, and able to comply with the required 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 Criteria: * Loose prosthesis or surgical treatment planned for removal of well-fixed, nonmodular implants * 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 confirmed PJI of the affected knee, including prior DAIR or revision surgery for PJI * Two or more prior revisions in the affected joint for reasons other than infection * Epithelialized sinus tract with evidence of communication to the joint or visualization of prosthesis * Diabetes mellitus and with an A1c โ‰ฅ9% within 3 months, according to medical history * 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; human immunodeficiency virus \[HIV\] with recent CD4 count \<200 cells/mm3; or primary humoral, bone marrow, or other transplantation)
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What it tests

  • PLG0206
  • Placebo
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Where

21 sites
Clinical Trial Site
Sarasota, United States
Clinical Trial Site
Tamarac, United States
Clinical Trial Site
Shreveport, United States
Clinical Trial Site
Baltimore, United States
Clinical Trial Site
Boston, United States
Clinical Trial Site
New York, United States
Clinical Trial Site
Leland, United States
Clinical Trial Site
Cincinnati, United States

โ€ฆand 13 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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