Study on Antibiotic Treatment for Hip and Knee Joint Infections Using Linezolid, Fusidic Acid, and Rifampicin

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What is this study about?

This clinical trial is focused on studying infections that occur around artificial joints, specifically in the hip and knee. These infections are known as periprosthetic joint infections. The study aims to evaluate how well different antibiotics work in treating these infections. The antibiotics being studied include Linezolid, Fusidic Acid, Rifampicin, Ofloxacin Hydrochloride, Sulfamethoxazole and Trimethoprim, and Clindamycin. These medications are all types of antibiotics, which are drugs used to treat infections caused by bacteria.

The purpose of the study is to see if using a method called Minimum Biofilm Eradication Concentration (MBEC) along with another method called Minimum Inhibitory Concentration (MIC) can help guide the treatment of these infections more effectively. The study will compare how these methods affect the resolution of the infection, the body’s tolerance to the drugs, and the patterns of resistance that might develop in the bacteria causing the infection. Participants in the study will receive one of the antibiotics mentioned, or a placebo, and their progress will be monitored over a period of time.

Throughout the study, participants will be observed for up to 12 months to track various outcomes, such as the need for additional procedures, the recurrence of infection, and overall health status. The study will also look at the resources used during treatment, such as hospital stays and outpatient visits, and the costs associated with these. The goal is to find the most effective way to treat periprosthetic joint infections and improve patient outcomes.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. This study aims to evaluate the effectiveness of different antibiotic treatments for infections around hip or knee implants.

2 initial treatment

You will receive an initial treatment for 14 days with intravenous antibiotics, either cloxacillin or vancomycin. This is to address the infection in your hip or knee joint.

3 antibiotic regimen

After the initial treatment, you will be assigned to a specific antibiotic regimen based on test results. These tests will determine the best antibiotics to use, considering how well they can eliminate bacteria in biofilms, which are protective layers that bacteria form.

4 medication administration

You will take oral antibiotics, which may include linezolid, fusidic acid, rifampicin, levofloxacin, sulfamethoxazole and trimethoprim, or clindamycin. The specific dosage and frequency will be determined by your healthcare provider based on the test results.

5 monitoring and follow-up

Throughout the study, your health and response to the treatment will be closely monitored. You will have regular follow-up visits to assess the effectiveness of the treatment and to check for any side effects.

6 evaluation of outcomes

The study will evaluate various outcomes, such as the resolution of the infection, any need for additional procedures, and your overall health status. This will be assessed over a period of up to 12 months.

Who Can Join the Study?

Must have a first-time infection in the hip or knee joint, known as periprosthetic joint infection (PJI), which is an infection around a joint replacement.
The infection must be a mono-microbial staphylococcal infection, meaning it is caused by a single type of bacteria called staphylococcus.
Must have undergone a procedure called DAIR, which stands for debridement, antibiotics, and implant retention. This is a treatment method where the infected area is cleaned, antibiotics are given, and the implant is kept in place.
Must have received 14 days of intravenous treatment with either cloxacillin or vancomycin, which are types of antibiotics given through a vein.
Must have had a standardized administration of local antibiotics, meaning antibiotics were applied directly to the infected area in a consistent manner.
Open to both male and female participants.
Participants must be adults.

Who Cannot Join the Study?

Patients with periprosthetic hip joint infection cannot participate. This means an infection around a hip joint replacement.
Patients with periprosthetic knee joint infection cannot participate. This means an infection around a knee joint replacement.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen	Boras	Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not yet recruiting	01.01.2021

Trial locations

Investigated drugs:

Antibiotics are medicines used to treat infections caused by bacteria. In this clinical trial, antibiotics are being tested to see how well they work against infections that occur around joint implants, like hip or knee replacements. The study is looking at how effective these antibiotics are when used in different ways to stop the bacteria from growing and to completely get rid of the bacteria that form a protective layer called a biofilm. This biofilm can make infections harder to treat, so the trial is testing if using antibiotics in a new way can help clear these infections better.

Investigated diseases:

Medical device site joint infection

Periprosthetic Hip Joint Infection – This condition occurs when bacteria or other microorganisms infect the tissues surrounding a hip prosthesis. It typically begins with the introduction of bacteria during or after surgery. The infection can cause inflammation, pain, and swelling around the joint. Over time, it may lead to loosening of the prosthetic joint, resulting in decreased mobility and function. The progression of the infection can vary, with some cases remaining localized while others may spread to surrounding tissues. Chronic infections can develop if the condition is not addressed promptly.

Periprosthetic Knee Joint Infection – This disease involves the infection of tissues surrounding a knee prosthesis, often caused by bacteria introduced during or after knee replacement surgery. The infection can lead to symptoms such as pain, swelling, and warmth around the knee joint. As the infection progresses, it may cause the prosthetic joint to become loose, affecting the patient’s ability to move the knee. The condition can remain localized or spread to adjacent tissues, depending on the severity and response to the infection. If not managed, it can become chronic, leading to ongoing joint issues.

Trial ID:

2024-518350-17-00

NCT ID:

NCT04488458

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Antibiotic Treatment for Hip and Knee Joint Infections Using Linezolid, Fusidic Acid, and Rifampicin

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?