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
NCT ID: NCT07214311
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
240 participants
INTERVENTIONAL
2025-12-31
2028-09-30
Brief Summary
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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.
Detailed Description
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Eligible participants will undergo a DAIR procedure according to the treating hospital's standard of care (SOC). Participant eligibility will be based on clinical and diagnostic assessments, including laboratory results.
Once debridement during DAIR is complete, the Investigator will follow a standardized irrigation protocol, with the final irrigation step being administration of a single dose of blinded study drug (PLG0206 or matching placebo). The study drug will be administered as a single intra-articular irrigation.
Following study drug administration, all participants will receive standard post-operative care per institutional guidelines and will be discharged from the hospital in accordance with local standards. Participants may receive IV/oral antimicrobial therapy, as part of post-operative SOC.
Participants will be monitored for safety and signs of PJI recurrence or persistent infection for 365 days post study drug administration. After hospital discharge, study visits will occur in-clinic on Days 14, 90, and 365, and on Days 30, 180, and 270 via a telephone or virtual visit.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PLG0206
PLG0206 will be administered as an irrigation solution during DAIR procedure
PLG0206
PLG0206 Solution
Placebo
Placebo (normal saline) will be administered as an irrigation solution during DAIR procedure
Placebo
Placebo
Interventions
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PLG0206
PLG0206 Solution
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
80 Years
ALL
No
Sponsors
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Peptilogics
INDUSTRY
Responsible Party
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Locations
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Clinical Trial Site
Baltimore, Maryland, United States
Clinical Trial Site
Columbus, Ohio, United States
Countries
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Central Contacts
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Other Identifiers
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PLG0206-PJI-300
Identifier Type: -
Identifier Source: org_study_id