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RETAIN: Study of PLG0206 to Prevent Recurrent Infection After Debridement, Antibiotics, and Implant Retention (DAIR) for Prosthetic Joint Infection Following Knee Replacement
Led by Peptilogics · Updated on 2026-05-14
240
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether the investigational drug PLG0206 can reduce the recurrence of infection in adults who have had a total knee replacement and are undergoing a DAIR (Debridement, Antibiotics, and Implant Retention) surgical procedure to treat a Prosthetic Joint Infection (PJI). The study also assesses the safety of PLG0206 when used as an irrigation solution during this procedure. Participants will be adults between 18 and 80 years old with suspected or confirmed knee PJI and a well-fixed prosthesis. During the DAIR procedure, participants will receive a single dose of either PLG0206 solution or a placebo irrigation solution after debridement, in addition to standard care treatments. Post-procedure, all participants will receive usual care including possible intravenous or oral antibiotics as per hospital guidelines. The study involves a randomized, placebo-controlled design with triple masking to compare PLG0206 against placebo. Participants will be monitored for safety and signs of infection recurrence for 365 days after receiving the study drug. Follow-up visits will occur in-clinic on Days 14, 90, and 365, with telephone or virtual visits on Days 30, 180, and 270. Researchers will assess treatment failure, surgical intervention rates, clinical outcomes, microbiological efficacy, and various safety and pharmacokinetic measures during this period.
CONDITIONS
Brief 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 prosthetic joint infection
- Agree to use contraceptives if of childbearing potential
You will not qualify if you...
- Loose prosthesis or planned removal of well-fixed, nonmodular implants
- Anticipated need for antibiotic therapy for more than 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 communicating to the joint or prosthesis visualization
- Diabetes mellitus with an A1c ≥9%
- History of malignant disease with immunosuppressive therapy, radiation, or chemotherapy within the past year
- Known immunodeficiency including splenectomy, sickle cell anemia, HIV with recent CD4 count <200 cells/mm3, or primary humoral, bone marrow, or other transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day (day of surgery)
Participants undergo a DAIR procedure where a single dose of the study drug (PLG0206 or placebo) is administered intraoperatively by local irrigation during surgery.
1 surgical procedure visit (in-person)
Duration - 365 days
After surgery, participants receive standard post-operative care and are monitored for safety and signs of infection recurrence for 365 days.
In-clinic visits on Days 14, 90, and 365; telephone or virtual visits on Days 30, 180, and 270
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
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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