RecruitingPHASE2, PHASE3INTERVENTIONAL

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

This research study is testing a new medicine called PLG0206. It's for people who have had a total knee replacement and have developed an infection in their new knee. When doctors treat these infections, they often perform a procedure called DAIR (Debridement, Antibiotics, and Implant Retention) to clean the joint and manage the infection. This study wants to find out if using PLG0206 as a rinse during the DAIR procedure can help stop the infection from coming back. Participants will either receive PLG0206 or a dummy treatment (placebo), along with their usual care. The study also checks how safe PLG0206 is. Everyone in the study will be watched closely for about a year after their procedure.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Peptilogics

Enrolment target

240

Start

03 Feb 2026

Estimated completion

01 Sep 2028

Prosthetic-joint Infection

What is this study about?

Knee replacement surgery is a common operation that can greatly improve a person's quality of life. However, sometimes an infection can develop around the new joint, which is called a periprosthetic joint infection (PJI). This can be a serious problem and often requires further treatment.

One way doctors treat these infections is with a procedure called DAIR, which stands for Debridement, Antibiotics, and Implant Retention. This involves carefully cleaning the infected area and giving antibiotics, usually without removing the knee replacement itself. This study is exploring a new medicine, PLG0206, which might help prevent the infection from returning after a DAIR procedure. Researchers want to see if using PLG0206 as a rinse during the DAIR surgery, alongside standard care, can make a difference.

The main goal of this study is to see if PLG0206 can reduce the chances of the infection coming back in people who've had a knee replacement and are undergoing the DAIR procedure for a PJI. The study will also carefully check for any side effects or safety concerns related to using PLG0206. By taking part, you could help doctors understand better how to prevent these infections and improve outcomes for future patients.

Key takeaways

This study investigates a new rinse, PLG0206, for knee replacement infections.
It aims to prevent infections from returning after a cleaning procedure (DAIR).
Participants will receive either PLG0206 or a dummy treatment (placebo).
The study also checks the safety of PLG0206.
Monitoring will last for approximately one year after surgery.
Your standard medical care for the infection will continue.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old. You must have an infection in your knee replacement (a PJI) that doctors believe can be treated with the DAIR procedure. Your knee replacement should be firmly in place, and the tissues around it should be in good condition. You also need to be able to understand the study, give your permission, and attend all the follow-up visits.

There are also some reasons why you might not be able to join. For example, if your knee replacement is loose or needs to be completely removed, or if your infection has spread beyond your knee. If you've had a history of knee infections in the same knee before, or if you have certain serious health conditions like uncontrolled diabetes or a weakened immune system, you might not be suitable. The study also cannot include you if you're expected to need antibiotics for more than six months after the DAIR procedure.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 80 years old?
Do you have an infection in your total knee replacement?
Is your knee replacement firmly in place and the surrounding tissue healthy?
Has your doctor said the DAIR procedure is suitable for your infection?
Are you able to attend follow-up appointments for about a year?

Answer every question to see your result.

What does participation involve?

If you join this study, you will undergo the DAIR procedure for your knee infection, just as your hospital normally performs it. During this surgery, after cleaning, you'll receive either PLG0206 or a matching dummy solution (placebo) as a rinse within your knee joint. You won't know which one you receive, and neither will your doctor, to ensure fair results. Following the procedure, you'll get your standard post-operative care, which may include antibiotics.

After leaving the hospital, you'll be monitored for approximately one year (365 days). This involves several follow-up visits: in-person visits at 14, 90, and 365 days after your treatment, and phone or video calls at 30, 180, and 270 days. During these visits, doctors will check your safety and look for any signs that your knee infection has returned or hasn't fully cleared up. The whole study monitoring period lasts for one year from the day you have your DAIR procedure.

Potential risks and benefits

Potential benefits of taking part include contributing to medical research that could help improve treatments for prosthetic joint infections in the future. While there's no guarantee the study drug will directly benefit you, you might receive a treatment that proves to be effective. As with any medical procedure or medication, there are potential risks, including side effects from the study drug or complications related to your surgery and recovery. The research team will explain all known risks. Remember, taking part in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (16)

Clinical Trial Site
Verified postcode
Sarasota, United States· Recruiting
Clinical Trial Site
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Tamarac, United States· Recruiting
Clinical Trial Site
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Shreveport, United States· Recruiting
Clinical Trial Site
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Baltimore, United States· Recruiting
Clinical Trial Site
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Boston, United States· Recruiting
Clinical Trial Site
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New York, United States· Recruiting
Clinical Trial Site
Verified postcode
Leland, United States· Recruiting
Clinical Trial Site
Verified postcode
Cincinnati, United States· Recruiting
Clinical Trial Site
Verified postcode
Cleveland, United States· Recruiting
Clinical Trial Site
Verified postcode
Columbus, United States· Recruiting
Clinical Trial Site
Verified postcode
Pittsburgh, United States· Recruiting
Clinical Trial Site
Verified postcode
Dallas, United States· Recruiting

Common questions

What is PLG0206?

PLG0206 is a new investigational medication being tested to see if it can help prevent knee replacement infections from coming back.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the study drug but contains no active medicine. It helps researchers fairly compare the new drug's effects.

How long will I be in the study?

You'll be monitored for about one year (365 days) after your knee cleaning procedure to check on your recovery and any return of infection.

Will I still get my usual treatment?

Yes, all participants will receive the standard DAIR procedure and any other care your doctors usually recommend for your knee infection alongside the study treatment.

Can I leave the study at any time?

Absolutely. Your participation is completely voluntary, and you can withdraw from the study at any point without any impact on your ongoing medical care.

How to find out more

Peptilogics RETAIN Study Lead

clinicaltrials@peptilogics.com 412-643-4924 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.