AuthorisedTherapeutic confirmatory (Phase III)Interventional

RIFAMAB : Rifabutin versus rifampicin for treatment of staphylococcal prosthetic joint infection treated with debridement, antibiotics and implant retention (DAIR strategy): a multicenter randomized, open-label, non-inferiority trial

This study is comparing two common antibiotics, rifabutin and rifampicin, to see which works best for people who have developed an infection in their artificial (prosthetic) joint, caused by *Staphylococcus* bacteria. These infections are being treated with a method called DAIR, which involves cleaning around the joint and giving antibiotics, without taking out the artificial joint itself. The main goal is to see if one antibiotic is as good as the other in preventing the infection from coming back or causing more surgery within one year. Researchers will also look at side effects, how well people take their medicine, and how their quality of life changes.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier De Tourcoing

Enrolment target

436

Start

07 Feb 2025

Adult with an staphylococcal prosthetic joint infection treated with debridement antibiotics and implant retention (DAIR strategy)

What is this study about?

Imagine you've had an operation to put in an artificial joint, like a new hip or knee. Sometimes, even with the best care, bacteria can cause an infection around this new joint. This can be very serious and upsetting. This study focuses on a specific type of infection caused by bacteria called *Staphylococcus*.

Doctors often treat these infections using a method called DAIR, which stands for Debridement, Antibiotics, and Implant Retention. This means they will clean the infected area around your artificial joint during a small operation, give you antibiotics to fight the bacteria, but importantly, they try to leave your new joint in place if possible. After this, you'll need to take antibiotics for a while.

This study is comparing two different antibiotics, rifabutin and rifampicin, which are both used to treat these kinds of infections. The main goal is to find out if rifabutin is just as effective as rifampicin in preventing the infection from causing more problems, such as needing another operation, or sadly, even leading to death related to the infection, within one year. They also want to make sure new antibiotics don't cause unexpected problems that weren't there when you started the treatment. By doing this research, doctors hope to offer the best possible treatment for people with these challenging infections.

Key takeaways

Compares two antibiotics (rifabutin vs. rifampicin) for artificial joint infections.
Focuses on infections caused by *Staphylococcus* bacteria.
Investigates treatment following a procedure called DAIR.
Aims to see which antibiotic is better at preventing complications for one year.
Monitors for side effects and how treatments affect quality of life.
Study lasts for two years after starting antibiotics.

Who may be eligible?

To be able to join this study, you must be an adult, 18 years old or older. The study is open to both men and women.

You must have an infection in your artificial joint that is caused by specific bacteria called *Staphylococcus*. This infection must be being treated with a special procedure called DAIR. This procedure involves cleaning around the joint and using antibiotics, while trying to keep your artificial joint in place.

There might be other reasons why you can or cannot join the study, which the medical team will discuss with you. They want to make sure the study is safe and appropriate for your specific health situation.

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 infection in your artificial joint?
Is your infection caused by a *Staphylococcus* bacteria?
Are you being treated with the DAIR method for this infection?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive one of two antibiotics: RIFADINE (rifampicin) or ANSATIPINE (rifabutin). You would take the assigned antibiotic, usually in capsule form, for a planned period of 12 weeks. Throughout this time, your health would be closely monitored.

This would involve regular visits to the clinic or hospital for check-ups and to ensure the treatment is working and not causing unexpected side effects. You would also be asked to keep a record of your medication, perhaps in a daily notebook, to help researchers understand how well you're taking your medicine.

After the initial 12 weeks of antibiotic treatment, you would continue to be followed up for a longer period. This follow-up would include regular assessments of your health, your joint, and your general well-being. You would periodically fill out questionnaires about your quality of life and your joint's function. The study aims to follow participants for a total of two years to see the long-term effects of the treatment.

Potential risks and benefits

Taking part in this study might offer a potential benefit of receiving closely monitored treatment for your artificial joint infection, potentially leading to better outcomes. However, like all medications, the antibiotics used in this study have potential side effects, such as liver or kidney problems, digestive issues, eye problems, or other neurological issues. Some side effects can be serious. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

—
Unverified
France

Common questions

What is an artificial joint infection?

It's when bacteria grow around a joint replacement (like a new hip or knee) causing pain, swelling, and other problems.

What is the DAIR procedure?

It's a way to treat these infections by cleaning the area around the joint and giving antibiotics, without always removing the artificial joint itself.

Why are they comparing two antibiotics?

Doctors want to find out if rifabutin works just as well as rifampicin, which are both used to treat these types of infections, and to understand their side effects better.

How long will I be in the study?

You'll take antibiotics for about 12 weeks, but your health will be checked regularly for up to two years to see the long-term effects.

What if I experience side effects?

The medical team will monitor you closely for any side effects and will adjust your treatment if needed. You should always tell them about any new symptoms you experience.