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NCT07214311
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
Conditions: Prosthetic-joint Infection
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 240
Sponsor: Peptilogics
Location: Clinical Trial Site Sarasota Florida
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Male or female participants age between 18 and \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 \
Source: ClinicalTrials.gov (NCT07214311). StuddyBuddy aggregates publicly available trial information.