AuthorisedTherapeutic use (Phase IV)Interventional

Evaluation of the clinical implementation of biofilm susceptibility to antibiotics using Minimum Biofilm Eradication Concentration (MBEC) in addition to Minimum Inhibitory Concentration (MIC) to guide the treatment of periprosthetic joint infections; a prospective randomized clinical trial

This research trial is focusing on people who have developed an infection around their artificial hip or knee joint. Doctors normally use a test (called MIC) to help decide which antibiotics might work best. This study wants to see if adding a new type of test (called MBEC) to the standard one can help doctors choose even more effective antibiotics. The aim is to find out if using both tests together leads to better treatment, reducing the need for more operations, preventing the infection from coming back, and improving people's overall well-being. This is a later-stage study, meaning the treatments involved are already available to patients.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Vaestra Goetalandsregionen

Enrolment target

Start

23 Oct 2024

Periprosthetic hip joint infection Periprosthetic knee joint infection

What is this study about?

This study is about a common problem for people who have had a hip or knee replacement – an infection around their new joint. When an infection happens, doctors need to choose the right antibiotics to get rid of it. Currently, they use a test called MIC (Minimum Inhibitory Concentration) to see which antibiotics can stop the bacteria from growing.

However, bacteria sometimes form a protective layer called a 'biofilm', which can make them much harder to kill. This study is exploring a new test called MBEC (Minimum Biofilm Eradication Concentration), which looks at how well antibiotics can break down these biofilms. The researchers want to know if using both the standard MIC test and the new MBEC test together helps doctors pick better antibiotics. They hope this will lead to more successful treatments and fewer problems for patients.

The main goal is to see if, over six weeks, combining these two tests helps doctors avoid using 'first-line' or standard antibiotics, suggesting they are finding more targeted and effective treatments. They will also be looking at longer-term effects over 12 months, such as whether patients need more surgery, if the infection comes back, how much pain people feel, their general health, how long their joint replacement lasts, and even the cost of care. This research aims to improve how these joint infections are treated in the future.

Key takeaways

This study is for people with infections around artificial hip or knee joints.
It aims to improve antibiotic choice by using a new test (MBEC) alongside a standard one (MIC).
The goal is to reduce infections coming back and avoid more surgery.
Participation involves receiving one of several common antibiotics.
The study monitors your health for up to a year.
It could lead to better infection treatments in the future.

Who may be eligible?

To take part in this study, you must be at least 18 years old. Both men and women are welcome to participate. The study is specifically looking for people who have an infection around their hip or knee replacement.

Infections around artificial joints can be complex, so the study will also have other specific medical rules about who can and cannot join. These rules ensure the study is safe for participants and that the results are clear. Your doctor will be able to check these in detail.

If you have an artificial hip or knee joint and have recently been diagnosed with an infection in that area, and you are over 18, you might be suitable for this study. Your medical team will be able to tell you if you meet all the necessary criteria.

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 18 years old or older?
Do you have an artificial hip joint?
Do you have an artificial knee joint?
Have you been diagnosed with an infection around your artificial joint?
Are you currently planning to receive antibiotic treatment for this infection?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be assigned to one of two groups. One group would have their treatment guided by the standard MIC test, and the other by both the MIC and the new MBEC test. You would receive antibiotics like Linezolid, Fusidic Acid, Rifampicin, Levofloxacin, Sulfamethoxazole and Trimethoprim, or Clindamycin as part of your treatment based on these test results.

Over the first six weeks, doctors will monitor how your treatment progresses. After that, for a full 12 months, the study team will keep track of your health. This will involve checking if you need any further procedures, if the infection returns, and how you are feeling generally using questionnaires like the Oxford Hip/Knee Score and EQ-5D. They will also look at how many times you visit the hospital or clinic, and gather information about healthcare costs. You will have regular appointments and check-ups to assess these various aspects of your care and recovery.

Potential risks and benefits

Participating in this study might offer the benefit of receiving treatment decisions based on more comprehensive testing, potentially leading to a more effective antibiotic regimen for your infection. However, like all medical treatments, the antibiotics used can have side effects, and there's always a risk that the infection might not clear up completely or could return. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

What is an artificial joint infection?

It's when germs get into the area around your new hip or knee joint, causing problems like pain, swelling, or fever.

What is the difference between MIC and MBEC?

MIC is a standard test to see which antibiotics stop bacteria from growing. MBEC is a new test looking at how well antibiotics can fight bacteria that have formed a protective layer called a 'biofilm'.

Will I get different antibiotics in this study?

The study uses commonly available antibiotics (like Linezolid, Rifampicin, etc.) but the choice of which one you get might be guided by different test results.

How long will I be involved in the study?

The main part of monitoring your treatment is for 6 weeks, but your health will be tracked for a total of 12 months.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without it affecting your usual medical care.