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
Recruiting
Phase 2Phase 3Interventional Study
Prosthetic-joint Infection
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
240 (estimated)
Sponsor
Peptilogics · Industry
Who this trial is looking for
This trial is looking for adults with a knee joint infection after a total knee replacement. Participants will receive either the study drug or a placebo along with their usual treatment and will be monitored for about a year.
Are You a Good Fit for This Trial?
Rules you outDiabetes mellitusActive cancer
You may be able to join if
I am between 18 and 80 years old.
I can give my consent and follow up as required.
I have a suspected or confirmed knee joint infection.
I have a well-fixed knee prosthesis.
I need a single DAIR procedure for my infection.
I agree to use contraception if I could become pregnant.
You may not be able to join if
I have a loose knee prosthesis.
I need antibiotic therapy for more than 6 months after the procedure.
My infection has spread beyond my knee joint.
I have had a previous knee joint infection.
I have had two or more surgeries on my knee joint.
I have an ongoing sinus tract connected to my knee joint.
I have diabetes with an A1c of 9% or higher.
I have a history of cancer and received certain treatments in the past year.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 solut…
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.
Trial Locations
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Eligibility Criteria
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 surr…
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)
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