PLG0206 for Prosthetic Joint Infection

(RETAIN Trial)

Recruiting at 2 trial locations

Overseen By Peptilogics RETAIN Study Lead

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Peptilogics

Disqualifiers: Diabetes, Malignant disease, Immunodeficiency, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 1 day

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called PLG0206 to determine if it can prevent recurring infections in individuals who have had a knee replacement and developed a joint infection. It compares PLG0206 to a placebo during a specific surgery called DAIR, which cleans out the infection. The trial also assesses the safety of PLG0206. Individuals who have had a total knee replacement, suspect an infection in that joint, and require a DAIR procedure may be suitable for this study. Researchers will follow participants for about a year after their surgery to monitor outcomes. As a Phase 2, Phase 3 trial, this study measures how well PLG0206 works in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that PLG0206 is likely to be safe for humans?

Research has shown that PLG0206 is generally safe for humans. In a recent study, healthy volunteers received PLG0206 through an IV drip, and it proved to be safe and well-tolerated. Another study involving patients with infections in artificial joints also reported positive safety results over six months.

These findings suggest that PLG0206 is likely safe. However, this trial continues to test its use during a specific surgery called a DAIR procedure. Researchers will closely monitor participants for about a year to ensure safety and gather more information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prosthetic joint infection?

Unlike most treatments for prosthetic joint infections, which often involve prolonged use of antibiotics and potential surgical interventions, PLG0206 offers a novel approach as an irrigation solution used during the DAIR procedure (Debridement, Antibiotics, and Implant Retention). Researchers are excited about PLG0206 because it directly targets and disrupts the biofilms that bacteria form on prosthetic joints, which are notoriously difficult to treat. This mechanism of action could potentially lead to more effective and quicker resolution of infections compared to standard treatments, reducing the need for more invasive surgeries and long-term antibiotic use.

What evidence suggests that PLG0206 might be an effective treatment for Prosthetic Joint Infection?

Research has shown that PLG0206, which participants in this trial may receive, might help treat infections in artificial joints. In earlier studies, PLG0206 significantly reduced bacteria, suggesting it could lower infection levels considerably. Positive results from early trials lasted up to 180 days in patients with these infections, indicating potential long-term benefits. In this trial, PLG0206 is used as a wash during surgery to directly target and reduce bacteria in the joint area. These findings suggest that PLG0206 might help prevent infections from recurring after joint replacement surgeries. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults under 80 who've had a knee replacement and now need a DAIR procedure for an infection. They must be able to consent, attend follow-ups, and use birth control if needed. It's not suitable for those outside the age range or with conditions that exclude them.

Inclusion Criteria

I can give informed consent, live in a stable location, and can attend all follow-up visits.

I agree to use birth control if I can have children.

I am between 18 and 79 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the DAIR procedure with administration of PLG0206 or placebo as an irrigation solution

1 day

1 visit (in-person)

Post-operative Care

Participants receive standard post-operative care and may receive IV/oral antimicrobial therapy

Varies

Follow-up

Participants are monitored for safety and signs of PJI recurrence or persistent infection

12 months

In-clinic visits on Days 14, 90, and 365; virtual visits on Days 30, 180, and 270

What Are the Treatments Tested in This Trial?

Interventions

• PLG0206

Trial Overview

The study tests PLG0206 as an irrigation solution during DAIR surgery against a placebo, alongside standard care. The aim is to see if PLG0206 can prevent infections from coming back after knee surgery.

How Is the Trial Designed?

Group I: PLG0206 Experimental Treatment 1 Intervention

PLG0206 will be administered as an irrigation solution during DAIR procedure

Group II: Placebo Placebo Group 1 Intervention

Placebo (normal saline) will be administered as an irrigation solution during DAIR procedure

Who Is Running the Clinical Trial?

Peptilogics

Lead Sponsor

Trials

1

Recruited

10+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07214311

Evaluation of PLG0206 in Prevention of Recurrent Infection ...

This study is designed to assess the efficacy and safety of PLG0206 administered intraoperatively by local irrigation to participants undergoing ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8612143/

Prospective Activity of PLG0206, an Engineered ...

A mean 4-log10 reduction (range, 1 to 7) in the number of bacteria occurred, which may translate to improved clinical outcomes for persons with ...

3.

peptilogics.com

peptilogics.com/news/peptilogics-reports-positive-180-day-top-line-interim-data-from-phase-1b-trial-of-plg0206-in-patients-with-periprosthetic-joint-infection-pji/

Peptilogics Reports Positive 180-Day Top Line Interim ...

Peptilogics Reports Positive 180-Day Top Line Interim Data From Phase 1b Trial of PLG0206 in Patients with Periprosthetic Joint Infection (PJI).

4.

boneandjoint.org.uk

boneandjoint.org.uk/Article/10.1302/1358-992X.2024.19.013

A CLINICAL EVALUATION OF THE SAFETY AND ...

This is the first clinical study to evaluate the safety and tolerability of PLG0206 when administered via an irrigation solution in patients ...

5.

journals.asm.org

journals.asm.org/doi/10.1128/aac.00338-25

Advancing the management of prosthetic joint infections

Peptilogics reports positive 180-day top line interim data from phase 1b trial of PLG0206 in patients with periprosthetic joint infection (PJI).

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8772972/

The Engineered Antibiotic Peptide PLG0206 Eliminates ...

A recent first-in-human study demonstrated that PLG0206 is well tolerated and safe as an intravenous infusion in healthy volunteers. Studies are ...

7.

peptilogics.com

peptilogics.com/news/peptilogics-completes-phase-1b-trial-enrollment-and-will-present-interim-top-line-safety-and-tolerability-data-of-plg0206-in-patients-undergoing-dair-for-the-treatment-of-periprosthetic-joint-infectio/

Peptilogics Completes Phase 1b Trial Enrollment and Will ...

PLG0206 has been granted FDA Orphan Drug Designation for the treatment of PJI and has also been designated as a Qualified Infectious Disease ...

8.

trials.arthritis.org

trials.arthritis.org/trials/NCT05137314

Study in Patients Undergoing Debridement, Antibiotics, and ...

The purpose of this study is to learn about the safety and effects of PLG0206 for treating periprosthetic joint infections (PJI) in conjunction with the DAIR.