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Prevention study for Prosthetic-joint Infection
Official title 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
ClinicalTrials.gov ID: NCT07214311
What this study is testing
What is PLG0206?
PLG0206 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prosthetic-joint infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Male or female participants age between 18 and \<80 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
You likely can't join if
- 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 PJI of the affected knee
- Two or more prior revisions in the affected joint
- Epithelialized sinus tract with evidence of communication to the joint or visualization of prosthesis
See the full eligibility criteria
- Male or female participants age between 18 and \<80 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
- 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 PJI of the affected knee
- Two or more prior revisions in the affected joint
- Epithelialized sinus tract with evidence of communication to the joint or visualization 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; human immunodeficiency virus [HIV] with recent CD4 count \<200 cells/mm3; or primary humoral, bone marrow, or other transplantation)
The study team makes the final eligibility decision.
Where it's taking place
- Sarasota, Florida, United States
- Tamarac, Florida, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Leland, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Dallas, Texas, United States
- Edinburg, Texas, United States
- Morgantown, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sarasota, Florida, United States; Tamarac, Florida, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; New York, New York, United States; Leland, North Carolina, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.