Actively Recruiting
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
Led by Peptilogics · Updated on 2026-05-14
240
Participants Needed
9
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 prosthetic joint infection 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
You will not qualify if you...
- 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 prosthetic joint infection 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 69%
- 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)
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Clinical Trial Site
Sarasota, Florida, United States, 34239
Actively Recruiting
2
Clinical Trial Site
Tamarac, Florida, United States, 33321
Actively Recruiting
3
Clinical Trial Site
Baltimore, Maryland, United States, 21215
Actively Recruiting
4
Clinical Trial Site
Boston, Massachusetts, United States, 02120
Actively Recruiting
5
Clinical Trial Site
Cincinnati, Ohio, United States, 45267
Actively Recruiting
6
Clinical Trial Site
Columbus, Ohio, United States, 43210
Actively Recruiting
7
Clinical Trial Site
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
8
Clinical Trial Site
Edinburg, Texas, United States, 78539
Actively Recruiting
9
Clinical Trial Site
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
P
Peptilogics RETAIN Study Lead
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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