PLG0206 irrigation to prevent repeat knee replacement infections after DAIR
RETAIN: A Phase 2/3 Randomized, Placebo-Controlled Study to Evaluate the Efficacy 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 Total Knee Arthroplasty (TKA)
This will test if washing the knee with PLG0206 during a DAIR procedure can lower the chance that a prosthetic knee infection comes back in adults who had a knee replacement.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peptilogics Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 8 sites (Sarasota, Florida and 7 other locations) |
| Trial ID | NCT07214311 on ClinicalTrials.gov |
What this trial studies
Adults with a suspected or confirmed prosthetic joint infection (PJI) after total knee arthroplasty who are having a DAIR (debridement, antibiotics, implant retention) procedure will be randomized to receive a single intraoperative irrigation of either PLG0206 or a placebo in addition to standard care. The irrigation is given after debridement according to a standardized protocol, and postoperative antibiotic therapy follows each site's usual practice. Participants will be followed for 365 days with scheduled clinic and remote visits to monitor safety and signs of infection recurrence. The primary focus is on whether the local PLG0206 irrigation reduces recurrent or persistent PJI compared with placebo while documenting adverse events.
Who should consider this trial
Good fit: Ideal candidates are adults 18 to under 80 years with a suspected or confirmed knee PJI after total knee replacement who have a well-fixed prosthesis, intact surrounding soft tissue, and for whom a single DAIR procedure is planned and they can attend year-long follow-up.
Not a fit: Patients unlikely to benefit include those with a loose prosthesis, infection that has spread beyond the joint, prior PJI of the same knee, multiple prior revisions, an epithelialized sinus tract, very poor diabetic control (A1c ≥9%), or those expected to need antibiotics for more than six months.
Why it matters
Potential benefit: If successful, PLG0206 irrigation could lower the risk that the knee infection returns and help patients avoid additional surgery to remove or revise the implant.
How similar studies have performed: Local antimicrobial lavage during DAIR has been used with mixed results, and PLG0206 is a novel investigational antimicrobial with limited prior clinical data in this specific setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 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 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)
Where this trial is running
Sarasota, Florida and 7 other locations
- Clinical Trial Site — Sarasota, Florida, United States (Recruiting)
- Clinical Trial Site — Tamarac, Florida, United States (Recruiting)
- Clinical Trial Site — Baltimore, Maryland, United States (Recruiting)
- Clinical Trial Site — Boston, Massachusetts, United States (Recruiting)
- Clinical Trial Site — Cincinnati, Ohio, United States (Recruiting)
- Clinical Trial Site — Columbus, Ohio, United States (Recruiting)
- Clinical Trial Site — Pittsburgh, Pennsylvania, United States (Recruiting)
- Clinical Trial Site — Morgantown, West Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Peptilogics RETAIN Study Lead
- Email: ClinicalTrials@peptilogics.com
- Phone: 412-643-4924
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.