PLG0206 irrigation to prevent repeat knee replacement infections after DAIR

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 ≥9% 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)

Where it's running

• Clinical Trial Site
  Sarasota, Florida, United States Recruiting
• Clinical Trial Site
  Tamarac, Florida, United States Recruiting
• Clinical Trial Site
  Shreveport, Louisiana, United States Recruiting
• Clinical Trial Site
  Boston, Massachusetts, United States Recruiting
• Clinical Trial Site
  Leland, North Carolina, United States Recruiting
• Clinical Trial Site
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: Peptilogics RETAIN Study Lead
• Email: ClinicalTrials@peptilogics.com
• Phone: 412-643-4924

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.