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

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Peptilogics
Study ID
NCT07214311
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Prosthetic-joint Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • PLG0206 — DRUG
    PLG0206 Solution
  • Placebo — DRUG
    Placebo

Study Details

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.

Key Dates

Start date
Feb 3, 2026
Status verified
May 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PLG0206
    PLG0206 will be administered as an irrigation solution during DAIR procedure
  • Placebo Comparator: Placebo
    Placebo (normal saline) will be administered as an irrigation solution during DAIR procedure

Primary Outcome Measure

Reduction in Treatment Failure Post DAIR [ Time Frame: From treatment through 12 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Clinical Trial SiteSarasotaFlorida34239-
Clinical Trial SiteTamaracFlorida33321-
Clinical Trial SiteBaltimoreMaryland21215-
Clinical Trial SiteBostonMassachusetts02120-
Clinical Trial SiteCincinnatiOhio45267-
Clinical Trial SiteColumbusOhio43210-
Clinical Trial SitePittsburghPennsylvania15232-
Clinical Trial SiteEdinburgTexas78539-
Clinical Trial SiteMorgantownWest Virginia26506-

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